<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03026764</url>
  </required_header>
  <id_info>
    <org_study_id>106362</org_study_id>
    <nct_id>NCT03026764</nct_id>
  </id_info>
  <brief_title>Inpatient vs Outpatient Total Hip Replacement</brief_title>
  <official_title>Patient Satisfaction and Costs Associated With Total Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Western Ontario, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a pragmatic randomized clinical trial comparing standard inpatient total hip&#xD;
      arthroplasty with same day discharge. Patients who are medically well and have a good support&#xD;
      structure at home will be randomized to inpatient or same day discharge. The investigators&#xD;
      will compare patient costs from the perspective of the Ministry of Health, the institution,&#xD;
      society and the patient. The investigators will also record complications, patient&#xD;
      satisfaction, functional ability and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total Hip Arthroplasty (THA) is currently one of the most successful procedures in&#xD;
      orthopaedics. Over the last 40 years, postoperative care has significantly evolved.&#xD;
      Initially, the standard procedure following THA was that patients were required to stay in&#xD;
      the hospital to recover for 2.5 to 3 weeks. However, with the implementation of less invasive&#xD;
      techniques, coupled with early weight bearing and more comprehensive postoperative&#xD;
      rehabilitation protocols, inpatient stays have drastically decreased on average to 2 to 3&#xD;
      days. A new, minimally invasive surgical (MIS) technique has led to an even larger decrease&#xD;
      in hospital stays, culminating in a same day discharge. The possibility of early&#xD;
      mobilization, combined with an increasing push from patients to accelerate recovery and&#xD;
      return to activities, have led to the implementation of outpatient THA in select patients.&#xD;
      For same day discharge to succeed, extensive preoperative and perioperative care must&#xD;
      accompany the procedure. Furthermore, more aggressive rehabilitation and improved pain&#xD;
      control is crucial for successful outpatient THA. For younger patients that need to return to&#xD;
      work as early as possible, a quicker recovery time is essential. Perfecting outpatient THA is&#xD;
      a crucial step towards achieving these requirements.&#xD;
&#xD;
      There are 4 major components to a successful THA: pain relief, functional recovery, patient&#xD;
      satisfaction and durable reconstruction. Outpatient THA is a fairly new concept in&#xD;
      arthroplasty, and patient satisfaction has not been properly assessed following this new THA&#xD;
      protocol. Satisfaction in accordance with THA refers to a patient achieving their functional&#xD;
      and pain expectations. A similar study evaluating patient satisfaction of a randomized&#xD;
      control trial (RCT) of inpatient versus outpatient anterior cruciate ligament (ACL)&#xD;
      reconstructions reported that outpatient satisfaction following surgery is higher than&#xD;
      inpatient satisfaction. Although this is a different procedure, it would seem outpatient ACL&#xD;
      reconstruction and outpatient THA has similar pain levels, safety and patient satisfaction.&#xD;
      The goal with outpatient surgery with regards to satisfaction is providing patients with&#xD;
      relief of their anxiety, while allowing them earlier control of their independence. Potential&#xD;
      advantages of outpatient surgery include that patients are permitted to recover in a secure,&#xD;
      private and comfortable home environment, while surgeons will improve efficiency and time&#xD;
      management with the decreased responsibilities of having to visit their inpatients.&#xD;
&#xD;
      In addition to the potential satisfaction benefit, outpatient THA is a potential source of&#xD;
      cost savings for both the patient and the hospital. Numerous efforts by hospitals have been&#xD;
      made to decrease costs and increase available beds for additional patients. A previous study&#xD;
      investigating the financial effects of outpatient THA found that the average hospital bill&#xD;
      for outpatients was $4000 less than for the inpatients. Including preoperative physical&#xD;
      therapy and home healthcare, the total charges for outpatients was $2500 less than&#xD;
      inpatients. A similar study demonstrated that select individuals can successfully undergo THA&#xD;
      in an outpatient setting with no increase in complications, while also receiving a&#xD;
      substantial savings to the patient and the healthcare system. By reducing costs and&#xD;
      increasing healthcare staff availability, hospitals can allocate more money to areas in need&#xD;
      of funding, while wait times can drastically reduce for future patients.&#xD;
&#xD;
      The most important part of preoperative care for a successful outpatient THA is giving the&#xD;
      patient appropriate goals and expectations. Patients should be educated by the&#xD;
      anaesthesiology team, the physical and occupational therapist, the surgeon, the nurses, and&#xD;
      anyone else involved in the surgery. Patients are required to attend classes explaining the&#xD;
      various aspects of the operative experience, as well as discharge goals and techniques for&#xD;
      postoperative home rehabilitation. Furthermore, functional and symptomatic goals need to be&#xD;
      clearly defined. In these educational sessions, pain management strategies are one of the&#xD;
      main focuses. To have a successful same day discharge, patients must be well versed in pain&#xD;
      management and proper rehabilitation strategies. Before the preoperative class, all patients&#xD;
      are instructed to practice certain skills, such as bed transfer, cane/crutches use and gait&#xD;
      training. Potential complications are discussed so that the patient is reassured with what is&#xD;
      normally supposed to happen following surgery. The goal of preoperative care is that the&#xD;
      patient has a defined set of goals and expectations for their surgery, medications, and&#xD;
      rehabilitation.&#xD;
&#xD;
      For outpatient THA surgery, it is preferred to perform the surgery in the morning to&#xD;
      facilitate same day discharge. Immediately following surgery, the primary goals are to treat&#xD;
      pain, nausea and hypovolemia. Prior to symptoms arriving, these issues have to be dealt with&#xD;
      using the proper fluids and medications. Physical therapy is usually initiated 3 to 4 hours&#xD;
      following surgery. The combination of this early rehabilitation program, combined with the&#xD;
      minimally invasive surgical technique is vital to the rapid recovery process. Home physical&#xD;
      therapy should begin immediately, with a focus on ambulation. The patient is then asked for a&#xD;
      follow-up visit within 1 week of the surgery to make sure all of the patient's goals have&#xD;
      been met.&#xD;
&#xD;
      The primary concern with outpatient THA is safety of the patient. There are also concerns&#xD;
      including emergency room readmissions in patients who have difficulty once home in the&#xD;
      immediate postoperative period. Furthermore, some patients will require transfer to an&#xD;
      inpatient facility when they are experiencing a delayed recovery after surgery.&#xD;
&#xD;
      Anecdotal data was collected prior to the start of this research project. Since there was a&#xD;
      clinical practice change, informal conversations with outpatient THA demonstrated that 10/11&#xD;
      patients would have outpatient surgery again, and 9/11 would recommend outpatient THA surgery&#xD;
      to others. These encouraging findings are an important justification for performing the&#xD;
      present study.&#xD;
&#xD;
      Although previous THA outpatient studies have demonstrated successful results, it is&#xD;
      imperative to complete a RCT to diminish any bias associated with these findings. In the&#xD;
      absence of high quality comparative evidence, the success in same day discharge THA may be a&#xD;
      result of selection bias, since previous research is largely driven by observational studies&#xD;
      of highly selected populations. This would severely decrease the generalizability of previous&#xD;
      studies. To our knowledge, this will be the first level one study that will investigate the&#xD;
      cost, early complications and patient satisfaction associated with outpatient THA in a&#xD;
      pragmatic selection of patients. This study will answer important questions on how to best&#xD;
      treat patients undergoing THA, and whether an earlier discharge following surgery affects&#xD;
      patient outcomes.&#xD;
&#xD;
      A retrospective analysis of over 50,000 THA and TKA procedures found no differences in 30-day&#xD;
      major complications or readmissions among patients with a zero to two-day hospital stay&#xD;
      compared to those discharged on day three or four postoperative. The rate of serious adverse&#xD;
      events in the inpatient group is expected to be greater than five percent. To define a&#xD;
      non-inferiority margin we agreed that no more than a five percent increase in the risk of&#xD;
      serious adverse event (RD ≥ 6% favoring inpatient care) was acceptable. If the risk in the&#xD;
      inpatient group ranges between five to eight percent and there is truly no difference in risk&#xD;
      of serious adverse event between the groups, then a maximum of 506 patients are required to&#xD;
      be 80% certain that the upper limit of a one-sided 95% confidence interval will exclude a&#xD;
      difference in favour of the inpatient group of more than six percent. Given that the primary&#xD;
      outcome is being measured at 3-months postoperative, we anticipate a low lost-to-follow-up&#xD;
      rate. Previous studies conducted at the study site in similar patients demonstrate loss to&#xD;
      follow up rates less than one percent for the first 3 months. Therefore, to account for a&#xD;
      potential one percent dropout rate we inflated our sample size to 511.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">March 30, 2022</completion_date>
  <primary_completion_date type="Actual">March 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Indirect and Direct Costs of Treatment</measure>
    <time_frame>3 months</time_frame>
    <description>ER visits, clinician visits, caregiver lost productivity, tests, etc</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Early complications and adverse events</measure>
    <time_frame>3 months</time_frame>
    <description>falls, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Standardized measure of health outcome (EQ-5D)</measure>
    <time_frame>3 months</time_frame>
    <description>utility</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction Questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>Patient satisfaction with care pre, peri and postoperative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Western Ontario McMaster Osteoarthritis Index (WOMAC)</measure>
    <time_frame>3 months</time_frame>
    <description>Functional outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Harris Hip Score</measure>
    <time_frame>3 months</time_frame>
    <description>Functional Outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form - 12</measure>
    <time_frame>3 months</time_frame>
    <description>Quality of Life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Numeric Scale Rating</measure>
    <time_frame>3 months</time_frame>
    <description>Pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Assistance Scale</measure>
    <time_frame>2 weeks</time_frame>
    <description>Caregiver Confidence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Strain Index</measure>
    <time_frame>2 weeks</time_frame>
    <description>Caregiver Strain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">558</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Outpatient</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the outpatient group (same day discharge following THA) are discharged the same day following surgery. All patients are required to meet the discharge criteria to be sent home (i.e., capable of using crutches, relatively free of pain, free of nausea and vomiting, free of excess bleeding, alert and oriented, given take-home medications, and in the company of a caregiver).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inpatient</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the inpatient group (following day discharge following THA) stay in the hospital overnight and then are discharged home the next day. All patients are required to meet the discharge criteria to be sent home (i.e., capable of using crutches, relatively free of pain, free of nausea and vomiting, free of excess bleeding, alert and oriented, given take-home medications, and in the company of a caregiver).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Outpatient</intervention_name>
    <description>Patients in the outpatient group will be discharged from the hospital the same day of surgery following a total hip arthroplasty</description>
    <arm_group_label>Outpatient</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Inpatient</intervention_name>
    <description>Patients in the inpatient group will be discharged from the hospital the following day after a total hip arthroplasty</description>
    <arm_group_label>Inpatient</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. American Society of Anaesthesiologists (ASA) score equal to or less than 3&#xD;
&#xD;
          2. Have the ability to read and understand English (printed instructions are provided in&#xD;
             English only)&#xD;
&#xD;
          3. Live within a 60 minute driving distance of University Hospital (UH)&#xD;
&#xD;
          4. Home / cell phone access&#xD;
&#xD;
          5. An adult to accompany patient home post-operatively&#xD;
&#xD;
          6. Sufficient caregiver support&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient has significant pain management issues&#xD;
&#xD;
          2. Patient / family history of anesthesia related complication(s) (e.g., malignant&#xD;
             hyperthermia, pseudocholinesterase deficiency, airway difficulties, obstructive sleep&#xD;
             apnea)&#xD;
&#xD;
          3. Obesity that significantly impacts the patient's ability to mobilize&#xD;
&#xD;
          4. Anaphylaxis to penicillin&#xD;
&#xD;
          5. Significant psycho / social issues that would prevent the patient from managing at&#xD;
             home safely&#xD;
&#xD;
          6. Cognitive issues that preclude the ability to understand instructions&#xD;
&#xD;
          7. Lack of an appropriate social network that can observe the patient post-operatively&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brent Lanting, MD, FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Health Sciences Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Aynardi M, Post Z, Ong A, Orozco F, Sukin DC. Outpatient surgery as a means of cost reduction in total hip arthroplasty: a case-control study. HSS J. 2014 Oct;10(3):252-5. doi: 10.1007/s11420-014-9401-0. Epub 2014 Jul 12.</citation>
    <PMID>25264442</PMID>
  </reference>
  <reference>
    <citation>Berger RA. Total hip arthroplasty using the minimally invasive two-incision approach. Clin Orthop Relat Res. 2003 Dec;(417):232-41. doi: 10.1097/01.blo.0000096828.67494.95.</citation>
    <PMID>14646722</PMID>
  </reference>
  <reference>
    <citation>Berger RA, Jacobs JJ, Meneghini RM, Della Valle C, Paprosky W, Rosenberg AG. Rapid rehabilitation and recovery with minimally invasive total hip arthroplasty. Clin Orthop Relat Res. 2004 Dec;(429):239-47. doi: 10.1097/01.blo.0000150127.80647.80.</citation>
    <PMID>15577494</PMID>
  </reference>
  <reference>
    <citation>Berger RA. A comprehensive approach to outpatient total hip arthroplasty. Am J Orthop (Belle Mead NJ). 2007 Sep;36(9 Suppl):4-5.</citation>
    <PMID>17948159</PMID>
  </reference>
  <reference>
    <citation>Bertin KC. Minimally invasive outpatient total hip arthroplasty: a financial analysis. Clin Orthop Relat Res. 2005 Jun;(435):154-63. doi: 10.1097/01.blo.0000157173.22995.cf.</citation>
    <PMID>15930933</PMID>
  </reference>
  <reference>
    <citation>Charnley J. Present status of total hip replacement. Ann Rheum Dis. 1971 Nov;30(6):560-4. doi: 10.1136/ard.30.6.560. No abstract available.</citation>
    <PMID>5130137</PMID>
  </reference>
  <reference>
    <citation>Dorr LD, Maheshwari AV, Long WT, Wan Z, Sirianni LE. Early pain relief and function after posterior minimally invasive and conventional total hip arthroplasty. A prospective, randomized, blinded study. J Bone Joint Surg Am. 2007 Jun;89(6):1153-60. doi: 10.2106/JBJS.F.00940.</citation>
    <PMID>17545416</PMID>
  </reference>
  <reference>
    <citation>Dorr LD, Thomas D, Long WT, Polatin PB, Sirianni LE. Psychologic reasons for patients preferring minimally invasive total hip arthroplasty. Clin Orthop Relat Res. 2007 May;458:94-100. doi: 10.1097/BLO.0b013e31803212dc.</citation>
    <PMID>17224839</PMID>
  </reference>
  <reference>
    <citation>Dorr LD, Thomas DJ, Zhu J, Dastane M, Chao L, Long WT. Outpatient total hip arthroplasty. J Arthroplasty. 2010 Jun;25(4):501-6. doi: 10.1016/j.arth.2009.06.005. Epub 2009 Jul 28.</citation>
    <PMID>19640672</PMID>
  </reference>
  <reference>
    <citation>Husted H, Holm G, Jacobsen S. Predictors of length of stay and patient satisfaction after hip and knee replacement surgery: fast-track experience in 712 patients. Acta Orthop. 2008 Apr;79(2):168-73. doi: 10.1080/17453670710014941.</citation>
    <PMID>18484241</PMID>
  </reference>
  <reference>
    <citation>Krywulak SA, Mohtadi NG, Russell ML, Sasyniuk TM. Patient satisfaction with inpatient versus outpatient reconstruction of the anterior cruciate ligament: a randomized clinical trial. Can J Surg. 2005 Jun;48(3):201-6.</citation>
    <PMID>16013623</PMID>
  </reference>
  <reference>
    <citation>Mancuso CA, Salvati EA, Johanson NA, Peterson MG, Charlson ME. Patients' expectations and satisfaction with total hip arthroplasty. J Arthroplasty. 1997 Jun;12(4):387-96. doi: 10.1016/s0883-5403(97)90194-7.</citation>
    <PMID>9195314</PMID>
  </reference>
  <reference>
    <citation>Lovell TP. Single-incision direct anterior approach for total hip arthroplasty using a standard operating table. J Arthroplasty. 2008 Oct;23(7 Suppl):64-8. doi: 10.1016/j.arth.2008.06.027.</citation>
    <PMID>18922376</PMID>
  </reference>
  <reference>
    <citation>Mears DC, Mears SC, Chelly JE, Dai F, Vulakovich KL. THA with a minimally invasive technique, multi-modal anesthesia, and home rehabilitation: factors associated with early discharge? Clin Orthop Relat Res. 2009 Jun;467(6):1412-7. doi: 10.1007/s11999-009-0785-y. Epub 2009 Mar 20. Erratum In: Clin Orthop Relat Res. 2009 Jul;467(7):1928.</citation>
    <PMID>19301081</PMID>
  </reference>
  <reference>
    <citation>Chen D, Berger RA. Outpatient minimally invasive total hip arthroplasty via a modified Watson-Jones approach: technique and results. Instr Course Lect. 2013;62:229-36.</citation>
    <PMID>23395028</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>March 9, 2016</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>August 17, 2022</last_update_submitted>
  <last_update_submitted_qc>August 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cost</keyword>
  <keyword>total hip replacement</keyword>
  <keyword>outpatient Surgery</keyword>
  <keyword>satisfaction</keyword>
  <keyword>arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03026764
org study id: 106362
nct id: NCT03026764
lead sponsor: 
collaborator: 
has dmc: No
This study is a pragmatic randomized clinical trial comparing standard inpatient total hip
      arthroplasty with same day discharge. Patients who are medically well and have a good support
      structure at home will be randomized to inpatient or same day discharge. The investigators
      will compare patient costs from the perspective of the Ministry of Health, the institution,
      society and the patient. The investigators will also record complications, patient
      satisfaction, functional ability and quality of life.
Total Hip Arthroplasty (THA) is currently one of the most successful procedures in
      orthopaedics. Over the last 40 years, postoperative care has significantly evolved.
      Initially, the standard procedure following THA was that patients were required to stay in
      the hospital to recover for 2.5 to 3 weeks. However, with the implementation of less invasive
      techniques, coupled with early weight bearing and more comprehensive postoperative
      rehabilitation protocols, inpatient stays have drastically decreased on average to 2 to 3
      days. A new, minimally invasive surgical (MIS) technique has led to an even larger decrease
      in hospital stays, culminating in a same day discharge. The possibility of early
      mobilization, combined with an increasing push from patients to accelerate recovery and
      return to activities, have led to the implementation of outpatient THA in select patients.
      For same day discharge to succeed, extensive preoperative and perioperative care must
      accompany the procedure. Furthermore, more aggressive rehabilitation and improved pain
      control is crucial for successful outpatient THA. For younger patients that need to return to
      work as early as possible, a quicker recovery time is essential. Perfecting outpatient THA is
      a crucial step towards achieving these requirements.

      There are 4 major components to a successful THA: pain relief, functional recovery, patient
      satisfaction and durable reconstruction. Outpatient THA is a fairly new concept in
      arthroplasty, and patient satisfaction has not been properly assessed following this new THA
      protocol. Satisfaction in accordance with THA refers to a patient achieving their functional
      and pain expectations. A similar study evaluating patient satisfaction of a randomized
      control trial (RCT) of inpatient versus outpatient anterior cruciate ligament (ACL)
      reconstructions reported that outpatient satisfaction following surgery is higher than
      inpatient satisfaction. Although this is a different procedure, it would seem outpatient ACL
      reconstruction and outpatient THA has similar pain levels, safety and patient satisfaction.
      The goal with outpatient surgery with regards to satisfaction is providing patients with
      relief of their anxiety, while allowing them earlier control of their independence. Potential
      advantages of outpatient surgery include that patients are permitted to recover in a secure,
      private and comfortable home environment, while surgeons will improve efficiency and time
      management with the decreased responsibilities of having to visit their inpatients.

      In addition to the potential satisfaction benefit, outpatient THA is a potential source of
      cost savings for both the patient and the hospital. Numerous efforts by hospitals have been
      made to decrease costs and increase available beds for additional patients. A previous study
      investigating the financial effects of outpatient THA found that the average hospital bill
      for outpatients was $4000 less than for the inpatients. Including preoperative physical
      therapy and home healthcare, the total charges for outpatients was $2500 less than
      inpatients. A similar study demonstrated that select individuals can successfully undergo THA
      in an outpatient setting with no increase in complications, while also receiving a
      substantial savings to the patient and the healthcare system. By reducing costs and
      increasing healthcare staff availability, hospitals can allocate more money to areas in need
      of funding, while wait times can drastically reduce for future patients.

      The most important part of preoperative care for a successful outpatient THA is giving the
      patient appropriate goals and expectations. Patients should be educated by the
      anaesthesiology team, the physical and occupational therapist, the surgeon, the nurses, and
      anyone else involved in the surgery. Patients are required to attend classes explaining the
      various aspects of the operative experience, as well as discharge goals and techniques for
      postoperative home rehabilitation. Furthermore, functional and symptomatic goals need to be
      clearly defined. In these educational sessions, pain management strategies are one of the
      main focuses. To have a successful same day discharge, patients must be well versed in pain
      management and proper rehabilitation strategies. Before the preoperative class, all patients
      are instructed to practice certain skills, such as bed transfer, cane/crutches use and gait
      training. Potential complications are discussed so that the patient is reassured with what is
      normally supposed to happen following surgery. The goal of preoperative care is that the
      patient has a defined set of goals and expectations for their surgery, medications, and
      rehabilitation.

      For outpatient THA surgery, it is preferred to perform the surgery in the morning to
      facilitate same day discharge. Immediately following surgery, the primary goals are to treat
      pain, nausea and hypovolemia. Prior to symptoms arriving, these issues have to be dealt with
      using the proper fluids and medications. Physical therapy is usually initiated 3 to 4 hours
      following surgery. The combination of this early rehabilitation program, combined with the
      minimally invasive surgical technique is vital to the rapid recovery process. Home physical
      therapy should begin immediately, with a focus on ambulation. The patient is then asked for a
      follow-up visit within 1 week of the surgery to make sure all of the patient's goals have
      been met.

      The primary concern with outpatient THA is safety of the patient. There are also concerns
      including emergency room readmissions in patients who have difficulty once home in the
      immediate postoperative period. Furthermore, some patients will require transfer to an
      inpatient facility when they are experiencing a delayed recovery after surgery.

      Anecdotal data was collected prior to the start of this research project. Since there was a
      clinical practice change, informal conversations with outpatient THA demonstrated that 10/11
      patients would have outpatient surgery again, and 9/11 would recommend outpatient THA surgery
      to others. These encouraging findings are an important justification for performing the
      present study.

      Although previous THA outpatient studies have demonstrated successful results, it is
      imperative to complete a RCT to diminish any bias associated with these findings. In the
      absence of high quality comparative evidence, the success in same day discharge THA may be a
      result of selection bias, since previous research is largely driven by observational studies
      of highly selected populations. This would severely decrease the generalizability of previous
      studies. To our knowledge, this will be the first level one study that will investigate the
      cost, early complications and patient satisfaction associated with outpatient THA in a
      pragmatic selection of patients. This study will answer important questions on how to best
      treat patients undergoing THA, and whether an earlier discharge following surgery affects
      patient outcomes.

      A retrospective analysis of over 50,000 THA and TKA procedures found no differences in 30-day
      major complications or readmissions among patients with a zero to two-day hospital stay
      compared to those discharged on day three or four postoperative. The rate of serious adverse
      events in the inpatient group is expected to be greater than five percent. To define a
      non-inferiority margin we agreed that no more than a five percent increase in the risk of
      serious adverse event (RD ≥ 6% favoring inpatient care) was acceptable. If the risk in the
      inpatient group ranges between five to eight percent and there is truly no difference in risk
      of serious adverse event between the groups, then a maximum of 506 patients are required to
      be 80% certain that the upper limit of a one-sided 95% confidence interval will exclude a
      difference in favour of the inpatient group of more than six percent. Given that the primary
      outcome is being measured at 3-months postoperative, we anticipate a low lost-to-follow-up
      rate. Previous studies conducted at the study site in similar patients demonstrate loss to
      follow up rates less than one percent for the first 3 months. Therefore, to account for a
      potential one percent dropout rate we inflated our sample size to 511.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Care Provider)
measure: Indirect and Direct Costs of Treatment
time frame: 3 months
description: ER visits, clinician visits, caregiver lost productivity, tests, etc
measure: Early complications and adverse events
time frame: 3 months
description: falls, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc
measure: Standardized measure of health outcome (EQ-5D)
time frame: 3 months
description: utility
measure: Patient Satisfaction Questionnaire
time frame: 3 months
description: Patient satisfaction with care pre, peri and postoperative
measure: Western Ontario McMaster Osteoarthritis Index (WOMAC)
time frame: 3 months
description: Functional outcome
measure: Harris Hip Score
time frame: 3 months
description: Functional Outcome
measure: Short Form - 12
time frame: 3 months
description: Quality of Life
measure: Pain Numeric Scale Rating
time frame: 3 months
description: Pain
measure: Caregiver Assistance Scale
time frame: 2 weeks
description: Caregiver Confidence
measure: Caregiver Strain Index
time frame: 2 weeks
description: Caregiver Strain
arm group label: Outpatient
arm group type: Experimental
description: Patients in the outpatient group (same day discharge following THA) are discharged the same day following surgery. All patients are required to meet the discharge criteria to be sent home (i.e., capable of using crutches, relatively free of pain, free of nausea and vomiting, free of excess bleeding, alert and oriented, given take-home medications, and in the company of a caregiver).
arm group label: Inpatient
arm group type: Active Comparator
description: Patients in the inpatient group (following day discharge following THA) stay in the hospital overnight and then are discharged home the next day. All patients are required to meet the discharge criteria to be sent home (i.e., capable of using crutches, relatively free of pain, free of nausea and vomiting, free of excess bleeding, alert and oriented, given take-home medications, and in the company of a caregiver).
intervention type: Procedure
intervention name: Outpatient
description: Patients in the outpatient group will be discharged from the hospital the same day of surgery following a total hip arthroplasty
arm group label: Outpatient
intervention type: Procedure
intervention name: Inpatient
description: Patients in the inpatient group will be discharged from the hospital the following day after a total hip arthroplasty
arm group label: Inpatient
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Brent Lanting, MD, FRCSC
role: Principal Investigator
affiliation: London Health Sciences Centre
facility: 
country: Canada
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PMID: 25264442
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PMID: 14646722
citation: Berger RA, Jacobs JJ, Meneghini RM, Della Valle C, Paprosky W, Rosenberg AG. Rapid rehabilitation and recovery with minimally invasive total hip arthroplasty. Clin Orthop Relat Res. 2004 Dec;(429):239-47. doi: 10.1097/01.blo.0000150127.80647.80.
PMID: 15577494
citation: Berger RA. A comprehensive approach to outpatient total hip arthroplasty. Am J Orthop (Belle Mead NJ). 2007 Sep;36(9 Suppl):4-5.
PMID: 17948159
citation: Bertin KC. Minimally invasive outpatient total hip arthroplasty: a financial analysis. Clin Orthop Relat Res. 2005 Jun;(435):154-63. doi: 10.1097/01.blo.0000157173.22995.cf.
PMID: 15930933
citation: Charnley J. Present status of total hip replacement. Ann Rheum Dis. 1971 Nov;30(6):560-4. doi: 10.1136/ard.30.6.560. No abstract available.
PMID: 5130137
citation: Dorr LD, Maheshwari AV, Long WT, Wan Z, Sirianni LE. Early pain relief and function after posterior minimally invasive and conventional total hip arthroplasty. A prospective, randomized, blinded study. J Bone Joint Surg Am. 2007 Jun;89(6):1153-60. doi: 10.2106/JBJS.F.00940.
PMID: 17545416
citation: Dorr LD, Thomas D, Long WT, Polatin PB, Sirianni LE. Psychologic reasons for patients preferring minimally invasive total hip arthroplasty. Clin Orthop Relat Res. 2007 May;458:94-100. doi: 10.1097/BLO.0b013e31803212dc.
PMID: 17224839
citation: Dorr LD, Thomas DJ, Zhu J, Dastane M, Chao L, Long WT. Outpatient total hip arthroplasty. J Arthroplasty. 2010 Jun;25(4):501-6. doi: 10.1016/j.arth.2009.06.005. Epub 2009 Jul 28.
PMID: 19640672
citation: Husted H, Holm G, Jacobsen S. Predictors of length of stay and patient satisfaction after hip and knee replacement surgery: fast-track experience in 712 patients. Acta Orthop. 2008 Apr;79(2):168-73. doi: 10.1080/17453670710014941.
PMID: 18484241
citation: Krywulak SA, Mohtadi NG, Russell ML, Sasyniuk TM. Patient satisfaction with inpatient versus outpatient reconstruction of the anterior cruciate ligament: a randomized clinical trial. Can J Surg. 2005 Jun;48(3):201-6.
PMID: 16013623
citation: Mancuso CA, Salvati EA, Johanson NA, Peterson MG, Charlson ME. Patients' expectations and satisfaction with total hip arthroplasty. J Arthroplasty. 1997 Jun;12(4):387-96. doi: 10.1016/s0883-5403(97)90194-7.
PMID: 9195314
citation: Lovell TP. Single-incision direct anterior approach for total hip arthroplasty using a standard operating table. J Arthroplasty. 2008 Oct;23(7 Suppl):64-8. doi: 10.1016/j.arth.2008.06.027.
PMID: 18922376
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PMID: 19301081
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PMID: 23395028
responsible party type: Sponsor
mesh term: Osteoarthritis
sharing ipd: No