<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/NCT03822247</url>
  </required_header>
  <id_info>
    <org_study_id>KBC Zagreb Surgery</org_study_id>
    <nct_id>NCT03822247</nct_id>
  </id_info>
  <brief_title>Evaluation of Multidisciplinary Recovery After Surgery Program in Orthopedics and Traumatology</brief_title>
  <official_title>A Prospective, Randomized Comparison of Multidisciplinary Recovery After Surgery Program and Conventional Protocol for Perioperative Care in Orthopedics and Traumatology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klinički Bolnički Centar Zagreb</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Klinički Bolnički Centar Zagreb</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the recovery protocol is to reduce surgical trauma, postoperative pain, and&#xD;
      complications, shorten hospital treatment and improve postoperative recovery. Orthopedic and&#xD;
      traumatology surgeries are often followed by a long-lasting recovery with difficulties of&#xD;
      everyday functioning. Up to this time, only a few publications of multidisciplinary protocol&#xD;
      in orthopedics and traumatology have been published, mostly to improve the care of patients&#xD;
      after elective surgical procedures. The goal of multidisciplinary after surgery recovery&#xD;
      program in orthopedics and traumatology is to improve the care of both urgent and elective&#xD;
      patients using standardized, multi-professional care programs. It focuses on patient&#xD;
      education, preoperative respiratory training, adequate nutritive and hemodynamic support,&#xD;
      modified anesthesia protocol, prevention of postoperative pain, nausea and vomiting, and&#xD;
      early postoperative delirium detection. The implementation of the program will reduce the&#xD;
      rate of postoperative complications and the rate of rehospitalization, enhance the recovery&#xD;
      after surgery and increase the satisfaction with the treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The protocol combines scientifically proven interventions to standardize medical care,&#xD;
      improve treatment outcomes and reduce healthcare costs. The aim is to reduce surgical trauma&#xD;
      and postoperative pain, reduce complications, shorten hospital treatment and improve&#xD;
      postoperative recovery. Moreover, it has been shown that using standardized, patient oriented&#xD;
      recovery protocol significantly improves the outcomes and quality of care, but also brings&#xD;
      financial benefit for the hospital as well as for the health system in general. Studies about&#xD;
      implementing multidisciplinary recovery protocol in orthopedic and traumatology are scarce.&#xD;
      Orthopedic and traumatology surgeries are often followed by a long-lasting and demanding&#xD;
      recovery characterized by the difficulties of everyday functioning. Recovery is therefore&#xD;
      multidisciplinary: for example, it is necessary to monitor the nutritional status of a&#xD;
      patient, decrease postoperative pain, monitor cognitive status, etc. Until now only a few&#xD;
      publications of recovery protocols in orthopedics and traumatology have been published,&#xD;
      mostly to improve the care of patients after elective surgical procedures. The goal of this&#xD;
      protocol in orthopedics and traumatology is to improve the care of both urgent and elective&#xD;
      patients using standardized, multi-professional care programs. It was created based on&#xD;
      evidence-based practice and modified by multidisciplinary team of orthopedic and traumatology&#xD;
      surgeons, anesthesiologists, physiatrist, physiotherapists, specialized medical nurses,&#xD;
      nutritionists, and psychiatrists. It focuses on patient preoperative education, preoperative&#xD;
      respiratory training, adequate nutritive and hemodynamic support, modified local and regional&#xD;
      anesthesia protocol, prevention of postoperative pain, nausea and vomiting, and early&#xD;
      postoperative delirium detection. The investigators postulate that the implementation of this&#xD;
      program will reduce the rate of postoperative complications and the rate of&#xD;
      rehospitalization, enhance the recovery after surgery and increase the satisfaction with the&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">January 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Early Postoperative Complications</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>Occurrence of early complications:&#xD;
Dislocation or malpositioning of joint replacement&#xD;
Neurological deficit&#xD;
Need for blood transfusion&#xD;
Postoperative delirium&#xD;
Nausea or vomiting&#xD;
Pneumonia&#xD;
Headache&#xD;
Wound dehiscence, secretion, inflammation, bleeding</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Late Postoperative Complications</measure>
    <time_frame>10 days after surgery</time_frame>
    <description>Occurrence of late complications:&#xD;
Wound infection, healing by secundam&#xD;
Decubitus&#xD;
Fracture of joint replacement&#xD;
Aseptic loosening of hip joint replacement&#xD;
Infection of joint replacement&#xD;
Thromboembolism&#xD;
Need for a revision</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Readmission rates</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Rate of readmission to the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported outcome after orthopedic surgery using The Western Ontario and McMaster Universities Arthritis Index (WOMAC)</measure>
    <time_frame>2 days, 60 days after surgery, 90 days after surgery</time_frame>
    <description>The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into 3 subscales (pain, stiffness and physical function). The questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score; higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessment using Visual Analog Scale (VAS)</measure>
    <time_frame>1 day, 2 days, 60 days after surgery, 90 days after surgery</time_frame>
    <description>The Visual Analog Scale (VAS) is a unidimensional measure of pain intensity. It is a straight horizontal line of fixed length of 100 mm. The ends are defined as the extreme limits of pain orientated from the left (worst) to the right (best). The score represents the distance measured (mm) between the worst and best mark, providing a range of scores between 0-100. A higher score indicates greater pain intensity. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of health related quality of life using Euro Quality of Life Index (Euro QoL 5-D 5-L)</measure>
    <time_frame>baseline, 2 days, 60 days after surgery, 90 days after surgery</time_frame>
    <description>The instrument Euro Quality of Life Index (Euro QoL 5-D 5-L) measures five dimensions, Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression. Each dimension can be rated at five levels: from no problems to major problems. The five dimensions can be summed into a descriptive health state with 11111 representing no problems in any of the five health dimensions and 55555 indicating major problems in any of the five health dimensions. Second part of the instrument is the Visual Analogue Scale to assess health status at baseline, where 0 signifies worst imaginable health state, and 100 signifies best imaginable health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of patients' satisfaction with the care provided using The Short-form patient satisfaction questionnaire (PSQ-18)</measure>
    <time_frame>3 days after surgery</time_frame>
    <description>The Short-form patient satisfaction questionnaire (PSQ-18) contains 18 items tapping each of the seven dimension of satisfaction with medical care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with the doctor and accessibility and convenience. All items are scored so that high scores reflect satisfaction with medical care and after item scoring, items within the same subscale should be averaged together to create the seven subscale scores.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hip Fractures</condition>
  <condition>Knee Fracture</condition>
  <condition>Hip Arthritis</condition>
  <condition>Knee Arthritis</condition>
  <arm_group>
    <arm_group_label>Multidisciplinary Recovery Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two cohorts of patients will randomly be placed in either experimental od no intervention group.&#xD;
Patients undergoing Multidisciplinary Recovery After Surgery Program will gain better preparation for early mobilization after surgery, nutritional support, individually modified analgesia and psychological support during inpatient treatment. Program includes preoperative, intraoperative and postoperative multidisciplinary comprehensive interventions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Perioperative Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients undergoing conventional care</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Multidisciplinary Recovery Program</intervention_name>
    <description>Preoperative care:&#xD;
Patient's education&#xD;
Providing respiratory training&#xD;
Assessment of nutritional status&#xD;
Application of compression stockings&#xD;
Thromboembolism prophylaxis by low molecular weighted heparin&#xD;
Induction of hemodynamic support 12 hours before the surgery&#xD;
Oral carbohydrate solution loading until 2 hours before the surgery&#xD;
Intraoperative care:&#xD;
Maintaining normothermia&#xD;
Multimodal prevention of postoperative nausea and vomiting&#xD;
Use of spinal anesthesia&#xD;
Prevention of excessive blood loss&#xD;
Local anesthetic infiltration&#xD;
Postoperative care:&#xD;
Active pain control&#xD;
Early mobilization&#xD;
Early onset of oral nutrition&#xD;
Early delirium detection&#xD;
Application of compression stockings</description>
    <arm_group_label>Multidisciplinary Recovery Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fracture od proximal femur or knee fracture requiring surgery&#xD;
&#xD;
          -  Hip or knee arthrosis requiring joint replacement&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) score II or III&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive impairment&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  End stage of malignant disease&#xD;
&#xD;
          -  Decompensated heart or liver disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nikica Daraboš</last_name>
    <role>Study Chair</role>
    <affiliation>Head of Department of traumatology, bone and joint surgery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nikica Daraboš</last_name>
    <phone>+385 1 2388 203</phone>
    <email>nikica.darabos@kbc-zagreb.hr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sara Medved</last_name>
    <phone>+385 1 2388 394</phone>
    <email>smedved@kbc-zagreb.hr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>KBC Zagreb</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nikica Daraboš</last_name>
      <phone>+385 1 2388 203</phone>
      <email>nikica.darabos@kbc-zagreb.hr</email>
    </contact>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>February 16, 2019</last_update_submitted>
  <last_update_submitted_qc>February 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Klinički Bolnički Centar Zagreb</investigator_affiliation>
    <investigator_full_name>Nikica Darabos</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Recovery</keyword>
  <keyword>Patient reported outcome measures</keyword>
  <keyword>Hip fracture</keyword>
  <keyword>Hip arthritis</keyword>
  <keyword>Knee fracture</keyword>
  <keyword>Knee arthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
    <mesh_term>Knee Fractures</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/NCT03822247
org study id: KBC Zagreb Surgery
nct id: NCT03822247
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the recovery protocol is to reduce surgical trauma, postoperative pain, and
      complications, shorten hospital treatment and improve postoperative recovery. Orthopedic and
      traumatology surgeries are often followed by a long-lasting recovery with difficulties of
      everyday functioning. Up to this time, only a few publications of multidisciplinary protocol
      in orthopedics and traumatology have been published, mostly to improve the care of patients
      after elective surgical procedures. The goal of multidisciplinary after surgery recovery
      program in orthopedics and traumatology is to improve the care of both urgent and elective
      patients using standardized, multi-professional care programs. It focuses on patient
      education, preoperative respiratory training, adequate nutritive and hemodynamic support,
      modified anesthesia protocol, prevention of postoperative pain, nausea and vomiting, and
      early postoperative delirium detection. The implementation of the program will reduce the
      rate of postoperative complications and the rate of rehospitalization, enhance the recovery
      after surgery and increase the satisfaction with the treatment.
The protocol combines scientifically proven interventions to standardize medical care,
      improve treatment outcomes and reduce healthcare costs. The aim is to reduce surgical trauma
      and postoperative pain, reduce complications, shorten hospital treatment and improve
      postoperative recovery. Moreover, it has been shown that using standardized, patient oriented
      recovery protocol significantly improves the outcomes and quality of care, but also brings
      financial benefit for the hospital as well as for the health system in general. Studies about
      implementing multidisciplinary recovery protocol in orthopedic and traumatology are scarce.
      Orthopedic and traumatology surgeries are often followed by a long-lasting and demanding
      recovery characterized by the difficulties of everyday functioning. Recovery is therefore
      multidisciplinary: for example, it is necessary to monitor the nutritional status of a
      patient, decrease postoperative pain, monitor cognitive status, etc. Until now only a few
      publications of recovery protocols in orthopedics and traumatology have been published,
      mostly to improve the care of patients after elective surgical procedures. The goal of this
      protocol in orthopedics and traumatology is to improve the care of both urgent and elective
      patients using standardized, multi-professional care programs. It was created based on
      evidence-based practice and modified by multidisciplinary team of orthopedic and traumatology
      surgeons, anesthesiologists, physiatrist, physiotherapists, specialized medical nurses,
      nutritionists, and psychiatrists. It focuses on patient preoperative education, preoperative
      respiratory training, adequate nutritive and hemodynamic support, modified local and regional
      anesthesia protocol, prevention of postoperative pain, nausea and vomiting, and early
      postoperative delirium detection. The investigators postulate that the implementation of this
      program will reduce the rate of postoperative complications and the rate of
      rehospitalization, enhance the recovery after surgery and increase the satisfaction with the
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Early Postoperative Complications
time frame: 48 hours after surgery
description: Occurrence of early complications:
Dislocation or malpositioning of joint replacement
Neurological deficit
Need for blood transfusion
Postoperative delirium
Nausea or vomiting
Pneumonia
Headache
Wound dehiscence, secretion, inflammation, bleeding
measure: Late Postoperative Complications
time frame: 10 days after surgery
description: Occurrence of late complications:
Wound infection, healing by secundam
Decubitus
Fracture of joint replacement
Aseptic loosening of hip joint replacement
Infection of joint replacement
Thromboembolism
Need for a revision
measure: Readmission rates
time frame: 30 days after surgery
description: Rate of readmission to the hospital
measure: Patient-reported outcome after orthopedic surgery using The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
time frame: 2 days, 60 days after surgery, 90 days after surgery
description: The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into 3 subscales (pain, stiffness and physical function). The questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score; higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
measure: Pain assessment using Visual Analog Scale (VAS)
time frame: 1 day, 2 days, 60 days after surgery, 90 days after surgery
description: The Visual Analog Scale (VAS) is a unidimensional measure of pain intensity. It is a straight horizontal line of fixed length of 100 mm. The ends are defined as the extreme limits of pain orientated from the left (worst) to the right (best). The score represents the distance measured (mm) between the worst and best mark, providing a range of scores between 0-100. A higher score indicates greater pain intensity. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
measure: Assessment of health related quality of life using Euro Quality of Life Index (Euro QoL 5-D 5-L)
time frame: baseline, 2 days, 60 days after surgery, 90 days after surgery
description: The instrument Euro Quality of Life Index (Euro QoL 5-D 5-L) measures five dimensions, Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression. Each dimension can be rated at five levels: from no problems to major problems. The five dimensions can be summed into a descriptive health state with 11111 representing no problems in any of the five health dimensions and 55555 indicating major problems in any of the five health dimensions. Second part of the instrument is the Visual Analogue Scale to assess health status at baseline, where 0 signifies worst imaginable health state, and 100 signifies best imaginable health state.
measure: Evaluation of patients' satisfaction with the care provided using The Short-form patient satisfaction questionnaire (PSQ-18)
time frame: 3 days after surgery
description: The Short-form patient satisfaction questionnaire (PSQ-18) contains 18 items tapping each of the seven dimension of satisfaction with medical care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with the doctor and accessibility and convenience. All items are scored so that high scores reflect satisfaction with medical care and after item scoring, items within the same subscale should be averaged together to create the seven subscale scores.
arm group label: Multidisciplinary Recovery Program
arm group type: Experimental
description: Two cohorts of patients will randomly be placed in either experimental od no intervention group.
Patients undergoing Multidisciplinary Recovery After Surgery Program will gain better preparation for early mobilization after surgery, nutritional support, individually modified analgesia and psychological support during inpatient treatment. Program includes preoperative, intraoperative and postoperative multidisciplinary comprehensive interventions.
arm group label: Conventional Perioperative Care
arm group type: No Intervention
description: Patients undergoing conventional care
intervention type: Procedure
intervention name: Multidisciplinary Recovery Program
description: Preoperative care:
Patient's education
Providing respiratory training
Assessment of nutritional status
Application of compression stockings
Thromboembolism prophylaxis by low molecular weighted heparin
Induction of hemodynamic support 12 hours before the surgery
Oral carbohydrate solution loading until 2 hours before the surgery
Intraoperative care:
Maintaining normothermia
Multimodal prevention of postoperative nausea and vomiting
Use of spinal anesthesia
Prevention of excessive blood loss
Local anesthetic infiltration
Postoperative care:
Active pain control
Early mobilization
Early onset of oral nutrition
Early delirium detection
Application of compression stockings
arm group label: Multidisciplinary Recovery Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nikica Daraboš
role: Study Chair
affiliation: Head of Department of traumatology, bone and joint surgery
last name: Nikica Daraboš
phone: +385 1 2388 203
email: nikica.darabos@kbc-zagreb.hr
last name: Sara Medved
phone: +385 1 2388 394
email: smedved@kbc-zagreb.hr
facility: 
status: Recruiting
contact: 
country: Croatia
responsible party type: Principal Investigator
investigator affiliation: Klinički Bolnički Centar Zagreb
investigator full name: Nikica Darabos
investigator title: Assistant Professor
mesh term: Arthritis
mesh term: Fractures, Bone
mesh term: Hip Fractures
mesh term: Knee Fractures
sharing ipd: No