<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/NCT04458584</url>
  </required_header>
  <id_info>
    <org_study_id>D20092</org_study_id>
    <nct_id>NCT04458584</nct_id>
  </id_info>
  <brief_title>Restoration of Thumb Strength and Function in Basal Joint Arthritis: A Comparative Effectiveness Trial (RESTART)</brief_title>
  <acronym>RESTART</acronym>
  <official_title>Restoration of Thumb Strength and Function in Basal Joint Arthritis: A Comparative Effectiveness Trial (RESTART)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the basis for three widely held fundamental tenets&#xD;
      about surgical intervention for thumb basal joint arthritis;&#xD;
&#xD;
        1. Trapeziectomy with ligament reconstruction and metacarpal stabilization is associated&#xD;
           with superior functional outcomes and strength,&#xD;
&#xD;
        2. Preservation of the arthroplasty space correlates with functional outcomes, pain relief,&#xD;
           and restoration of strength after basal joint arthroplasty, and&#xD;
&#xD;
        3. Mitigation of metacarpophalangeal joint (MCPJ) hyperextension optimizes postoperative&#xD;
           strength after basal joint arthroplasty, regardless of surgical technique.&#xD;
&#xD;
      It is hypothesized that thumb basal joint arthroplasty with metacarpal stabilization, by&#xD;
      either ligament reconstruction (I) or suture suspension (II), provides greater improvement in&#xD;
      grip and pinch strength, and better hand function, than might be achieved following provision&#xD;
      of pain relief alone by simple trapeziectomy (III). Preservation of the arthroplasty space&#xD;
      will correlate positively, and MCPJ hyperextension will correlate negatively, with improved&#xD;
      thumb function and lateral pinch strength.&#xD;
&#xD;
      Primary Aims (within 3 procedure cohorts):&#xD;
&#xD;
        1. Compare pre-operative pinch and grip strength as well as patient-reported outcomes&#xD;
           (PROs) for pain in patients before and after lidocaine injection of the&#xD;
           trapeziometacarpal joint, prior to thumb basal joint arthroplasty;&#xD;
&#xD;
        2. Compare post-operative pinch and grip strength and PROs for pain and function at 3 and 6&#xD;
           months after thumb basal joint arthroplasty with pre-operative values before and after&#xD;
           lidocaine injection;&#xD;
&#xD;
        3. Correlate preservation of dynamic arthroplasty space as measured on a stress radiograph&#xD;
           with postoperative improvement in pinch and grip strength, and PROs for pain and&#xD;
           function;&#xD;
&#xD;
        4. Correlate dynamic MCP joint position and laxity with change in strength and&#xD;
           patient-reported pain and function to define optimal MCPJ position.&#xD;
&#xD;
      Secondary Aims (between 3 procedure cohorts):&#xD;
&#xD;
        1. Compare change in pre- and post-operative pinch and grip strength and PROs for pain and&#xD;
           function between patients having basal joint arthroplasty with and without specific&#xD;
           metacarpal stabilization;&#xD;
&#xD;
        2. Compare preservation of the dynamic arthroplasty space and improvement in strength and&#xD;
           patient-reported pain and function between arthroplasty groups; and&#xD;
&#xD;
        3. Compare changes in pinch and grip strength and PROs for pain and function with dynamic&#xD;
           MCPJ position between arthroplasty groups.&#xD;
&#xD;
        4. Compare postoperative neuritis and complications between surgical groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Procedures: Upon obtaining informed consent and within 4 weeks of the planned date of&#xD;
      surgery, each site coordinator will collect baseline clinical and demographic information, a&#xD;
      visual analogue score (VAS), the Patient-Reported Outcomes Measurement Information System&#xD;
      (PROMIS-10) Global Health Survey, the short form Disabilities of the Arm, Shoulder, and Hand&#xD;
      (QuickDASH) questionnaire and grip and then pinch measurements from the participant. On the&#xD;
      same day, and immediately following collection of baseline clinical data in the clinic, the&#xD;
      surgeon will anesthetize the trapeziometacarpal joint. Adequacy of the injection and&#xD;
      resulting anesthesia of the joint will be assessed by repeat of the VAS score. Following 15&#xD;
      minutes set time for the local anesthetic, the VAS diagram will again be completed by the&#xD;
      patient followed by recording of repeat grip and then pinch measurements. Each patient will&#xD;
      then undergo one of three pre-specified procedures; trapeziectomy with ligament&#xD;
      reconstruction-tendon interposition (LRTI) arthroplasty with flexor carpi radialis tendon;&#xD;
      trapeziectomy with suture suspensionplasty; or arthroscopic trapeziectomy with temporary&#xD;
      K-wire fixation. Patient follow-up visits are otherwise scheduled according to the surgeon's&#xD;
      routine and by clinical indication only. The patient will follow the routine postoperative&#xD;
      rehabilitation protocol and hand therapy program of the operating surgeon. Protective&#xD;
      splinting and exercise programs are to be utilized per surgeon protocol and&#xD;
      preference.Postoperative study assessment will occur at three and six months after operation,&#xD;
      The 3 and 6 month evaluation will include PROMIS-10 and QuickDASH surveys, completion of the&#xD;
      VAS pain diagram, and recording of grip, key, and pulp to pulp pinch strengths. Additionally,&#xD;
      specific notation of paresthesias, dysaesthesias, or sensitivity of the incision will be made&#xD;
      by the surgeon or hand therapist at the 3 and 6 month assessments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pre-operative pinch and grip strength as measured by kilograms of pressure within and between procedure cohorts before and after lidocaine injection of the trapeziometacarpal joint.</measure>
    <time_frame>Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery</time_frame>
    <description>Power grip using a Jamar (Jackson, MO) dynamometer, followed by lateral (key) and pulp-to-pulp pinch, will be recorded (in kilograms) with a pinch meter, taking the greater strength of three successive attempts at each position with a 15 second rest between each attempt. The dynamic position of the thumb metacarpophalangeal (MCP) joint will be recorded with a small goniometer during lateral pinch testing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Pain, pre- to post-operatively, as measured by a standard visual analogue score (VAS) diagram to grade perceived pain within and between procedure cohorts.</measure>
    <time_frame>Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery</time_frame>
    <description>The standard VAS diagram is a scale from 0 to 10 where 0 indicates No Pain (smiling face), and 10 indicates Worst possible, unbearable, excruciating pain (crying face).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient-Reported Function as measured by the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, within and between procedure cohorts.</measure>
    <time_frame>Baseline, 3 months and 6 months after surgery</time_frame>
    <description>The short form QuickDASH questionnaire will be completed as a reflection of patient-reported specific upper extremity function. Absolute improvement in QuickDASH score will be compared within groups longitudinally and between groups at each time point. QuickDASH scores range from 0 (no disability) to 100 (most severe disability).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Quality of Life as measured by the PROMIS-10 Global Health questionnaire, within and between procedure cohorts.</measure>
    <time_frame>Baseline, 3 months and 6 months after surgery</time_frame>
    <description>The PROMIS-10 Global Health measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. A higher score indicates better health.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications between procedure cohorts</measure>
    <time_frame>3 months and 6 months post surgery</time_frame>
    <description>Postoperative complications specifically related to superficial sensory neuritis or complex regional pain syndrome and wound related infection, between arthroplasty groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in absolute dynamic arthroplasty space height as measured by on a stress radiograph within and between procedure and cohorts</measure>
    <time_frame>Baseline, immediately after surgery, 1 month after surgery, 3 months and 6 months after surgery</time_frame>
    <description>The static and dynamic arthroplasty space will be comparatively assessed on immediate postop and sequential radiographs taken upon removal of plaster immobilization and K-wire fixation at 1 month, and at 3 and 6 months after surgery. Three and six month radiographs will be taken in Roberts anteroposterior (AP) and true lateral projections during lateral key pinch. The absolute arthroplasty space height, and its change over time following operation and plaster removal, will be correlated with improvement in strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dynamic metacarpophalangeal joint position (MCPJ) and laxity as measured by hand goniometer within and between procedure cohorts</measure>
    <time_frame>Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery</time_frame>
    <description>Dynamic position of the MCPJ will be measured with a hand goniometer during lateral pinch testing</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">165</enrollment>
  <condition>Osteoarthritis Thumb</condition>
  <arm_group>
    <arm_group_label>Ligament Reconstruction - Tendon Interposition (LRTI)</arm_group_label>
    <description>Patients undergoing thumb basal joint arthroplasty using LRTI procedure as treatment of osteoarthritis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Suture Suspensionplasty (SS)</arm_group_label>
    <description>Patients undergoing thumb basal joint arthroplasty using suture suspensionplasty (SS) procedure as treatment of osteoarthritis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arthroscopic Trapeziectomy (AT)</arm_group_label>
    <description>Patients undergoing thumb basal joint arthroplasty using arthroscopic trapeziectomy (AT) procedure as treatment of osteoarthritis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trapeziectomy with ligament reconstruction (I; LRTI)</intervention_name>
    <description>Thumb basal joint arthroplasty (surgical) using Trapeziectomy with ligament reconstruction (I; LRTI)</description>
    <arm_group_label>Ligament Reconstruction - Tendon Interposition (LRTI)</arm_group_label>
    <other_name>NOTE: NO devices or drugs are included as part of this intervention.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trapeziectomy with suture suspensionplasty (II; SS)</intervention_name>
    <description>Thumb basal joint arthroplasty (surgical) using Trapeziectomy with suture suspension-lastly (II; SS)</description>
    <arm_group_label>Suture Suspensionplasty (SS)</arm_group_label>
    <other_name>NOTE: NO devices or drugs are included as part of this intervention.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arthroscopic Trapeziectomy (III; AT)</intervention_name>
    <description>Thumb basal joint arthroplasty (surgical) using Arthroscopic Trapeziectomy (III; AT)</description>
    <arm_group_label>Arthroscopic Trapeziectomy (AT)</arm_group_label>
    <other_name>NOTE: NO devices or drugs are included as part of this intervention.</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive patients seen at participating centers who have failed non-operative&#xD;
        treatment and are considering primary basal joint arthroplasty for a diagnosis of thumb&#xD;
        basal joint osteoarthritis, post-traumatic arthritis, or have undergone a prior basal joint&#xD;
        procedure for either fracture or instability resulting in persistent synovitis and are&#xD;
        bothered by persistent symptoms, will be considered for participation in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females 21 years of age or older;&#xD;
&#xD;
          -  Undergoing elective non-prosthetic, primary basal joint arthroplasty;&#xD;
&#xD;
          -  Patient has necessary mental capacity to participate and comply with study protocol;&#xD;
&#xD;
          -  Patient is willing and able to give informed consent; and&#xD;
&#xD;
          -  Patient is willing to participate under the care of their chosen surgeon.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a diagnosis of rheumatoid arthritis, systemic lupus erythematosis,&#xD;
             psoriatic arthritis, or other related inflammatory arthritis;&#xD;
&#xD;
          -  Patients undergoing simultaneous bilateral hand procedures of any nature;&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding;&#xD;
&#xD;
          -  Women of reproductive potential unless there is a negative urine pregnancy test on the&#xD;
             day of surgery. Women of child bearing potential include those who are premenopausal&#xD;
             who have not had a bilateral oophorectomy, hysterectomy or tubal ligation.&#xD;
             Post-menopausal is defined as not having had a menstrual period for at least one&#xD;
             calendar year.&#xD;
&#xD;
          -  Vulnerable patient populations including prisoners and institutionalized individuals.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Vincent D Pellegrini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth-Hitchcock Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vincent D Pellegrini, MD</last_name>
    <phone>(603) 650-5133</phone>
    <email>Vincent.D.Pellegrini.Jr@hitchcock.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vincent D Pellegrini, MD</last_name>
      <phone>603-650-5133</phone>
      <email>Vincent.D.Pellegrini.Jr@hitchcock.org</email>
    </contact>
    <contact_backup>
      <last_name>Lance G Warhold, MD</last_name>
      <phone>(603) 650-5133</phone>
      <email>Lance.G.Warhold@hitchcock.org</email>
    </contact_backup>
    <investigator>
      <last_name>Lance G Warhold, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jennifer A Chickering, OTR, CHT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>January 12, 2023</last_update_submitted>
  <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Vincent D. Pellegrini</investigator_full_name>
    <investigator_title>Staff Physician, Orthopaedics</investigator_title>
  </responsible_party>
  <keyword>Ligament reconstruction</keyword>
  <keyword>Suspensionplasty</keyword>
  <keyword>Arthroscopic Trapeziectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <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/NCT04458584
org study id: D20092
nct id: NCT04458584
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the basis for three widely held fundamental tenets
      about surgical intervention for thumb basal joint arthritis;

        1. Trapeziectomy with ligament reconstruction and metacarpal stabilization is associated
           with superior functional outcomes and strength,

        2. Preservation of the arthroplasty space correlates with functional outcomes, pain relief,
           and restoration of strength after basal joint arthroplasty, and

        3. Mitigation of metacarpophalangeal joint (MCPJ) hyperextension optimizes postoperative
           strength after basal joint arthroplasty, regardless of surgical technique.

      It is hypothesized that thumb basal joint arthroplasty with metacarpal stabilization, by
      either ligament reconstruction (I) or suture suspension (II), provides greater improvement in
      grip and pinch strength, and better hand function, than might be achieved following provision
      of pain relief alone by simple trapeziectomy (III). Preservation of the arthroplasty space
      will correlate positively, and MCPJ hyperextension will correlate negatively, with improved
      thumb function and lateral pinch strength.

      Primary Aims (within 3 procedure cohorts):

        1. Compare pre-operative pinch and grip strength as well as patient-reported outcomes
           (PROs) for pain in patients before and after lidocaine injection of the
           trapeziometacarpal joint, prior to thumb basal joint arthroplasty;

        2. Compare post-operative pinch and grip strength and PROs for pain and function at 3 and 6
           months after thumb basal joint arthroplasty with pre-operative values before and after
           lidocaine injection;

        3. Correlate preservation of dynamic arthroplasty space as measured on a stress radiograph
           with postoperative improvement in pinch and grip strength, and PROs for pain and
           function;

        4. Correlate dynamic MCP joint position and laxity with change in strength and
           patient-reported pain and function to define optimal MCPJ position.

      Secondary Aims (between 3 procedure cohorts):

        1. Compare change in pre- and post-operative pinch and grip strength and PROs for pain and
           function between patients having basal joint arthroplasty with and without specific
           metacarpal stabilization;

        2. Compare preservation of the dynamic arthroplasty space and improvement in strength and
           patient-reported pain and function between arthroplasty groups; and

        3. Compare changes in pinch and grip strength and PROs for pain and function with dynamic
           MCPJ position between arthroplasty groups.

        4. Compare postoperative neuritis and complications between surgical groups.
Study Procedures: Upon obtaining informed consent and within 4 weeks of the planned date of
      surgery, each site coordinator will collect baseline clinical and demographic information, a
      visual analogue score (VAS), the Patient-Reported Outcomes Measurement Information System
      (PROMIS-10) Global Health Survey, the short form Disabilities of the Arm, Shoulder, and Hand
      (QuickDASH) questionnaire and grip and then pinch measurements from the participant. On the
      same day, and immediately following collection of baseline clinical data in the clinic, the
      surgeon will anesthetize the trapeziometacarpal joint. Adequacy of the injection and
      resulting anesthesia of the joint will be assessed by repeat of the VAS score. Following 15
      minutes set time for the local anesthetic, the VAS diagram will again be completed by the
      patient followed by recording of repeat grip and then pinch measurements. Each patient will
      then undergo one of three pre-specified procedures; trapeziectomy with ligament
      reconstruction-tendon interposition (LRTI) arthroplasty with flexor carpi radialis tendon;
      trapeziectomy with suture suspensionplasty; or arthroscopic trapeziectomy with temporary
      K-wire fixation. Patient follow-up visits are otherwise scheduled according to the surgeon's
      routine and by clinical indication only. The patient will follow the routine postoperative
      rehabilitation protocol and hand therapy program of the operating surgeon. Protective
      splinting and exercise programs are to be utilized per surgeon protocol and
      preference.Postoperative study assessment will occur at three and six months after operation,
      The 3 and 6 month evaluation will include PROMIS-10 and QuickDASH surveys, completion of the
      VAS pain diagram, and recording of grip, key, and pulp to pulp pinch strengths. Additionally,
      specific notation of paresthesias, dysaesthesias, or sensitivity of the incision will be made
      by the surgeon or hand therapist at the 3 and 6 month assessments.
observational model: Other
time perspective: Prospective
measure: Change in pre-operative pinch and grip strength as measured by kilograms of pressure within and between procedure cohorts before and after lidocaine injection of the trapeziometacarpal joint.
time frame: Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery
description: Power grip using a Jamar (Jackson, MO) dynamometer, followed by lateral (key) and pulp-to-pulp pinch, will be recorded (in kilograms) with a pinch meter, taking the greater strength of three successive attempts at each position with a 15 second rest between each attempt. The dynamic position of the thumb metacarpophalangeal (MCP) joint will be recorded with a small goniometer during lateral pinch testing.
measure: Change in Pain, pre- to post-operatively, as measured by a standard visual analogue score (VAS) diagram to grade perceived pain within and between procedure cohorts.
time frame: Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery
description: The standard VAS diagram is a scale from 0 to 10 where 0 indicates No Pain (smiling face), and 10 indicates Worst possible, unbearable, excruciating pain (crying face).
measure: Change in Patient-Reported Function as measured by the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, within and between procedure cohorts.
time frame: Baseline, 3 months and 6 months after surgery
description: The short form QuickDASH questionnaire will be completed as a reflection of patient-reported specific upper extremity function. Absolute improvement in QuickDASH score will be compared within groups longitudinally and between groups at each time point. QuickDASH scores range from 0 (no disability) to 100 (most severe disability).
measure: Change in Quality of Life as measured by the PROMIS-10 Global Health questionnaire, within and between procedure cohorts.
time frame: Baseline, 3 months and 6 months after surgery
description: The PROMIS-10 Global Health measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. A higher score indicates better health.
measure: Postoperative complications between procedure cohorts
time frame: 3 months and 6 months post surgery
description: Postoperative complications specifically related to superficial sensory neuritis or complex regional pain syndrome and wound related infection, between arthroplasty groups.
measure: Change in absolute dynamic arthroplasty space height as measured by on a stress radiograph within and between procedure and cohorts
time frame: Baseline, immediately after surgery, 1 month after surgery, 3 months and 6 months after surgery
description: The static and dynamic arthroplasty space will be comparatively assessed on immediate postop and sequential radiographs taken upon removal of plaster immobilization and K-wire fixation at 1 month, and at 3 and 6 months after surgery. Three and six month radiographs will be taken in Roberts anteroposterior (AP) and true lateral projections during lateral key pinch. The absolute arthroplasty space height, and its change over time following operation and plaster removal, will be correlated with improvement in strength.
measure: Change in dynamic metacarpophalangeal joint position (MCPJ) and laxity as measured by hand goniometer within and between procedure cohorts
time frame: Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery
description: Dynamic position of the MCPJ will be measured with a hand goniometer during lateral pinch testing
arm group label: Ligament Reconstruction - Tendon Interposition (LRTI)
description: Patients undergoing thumb basal joint arthroplasty using LRTI procedure as treatment of osteoarthritis.
arm group label: Suture Suspensionplasty (SS)
description: Patients undergoing thumb basal joint arthroplasty using suture suspensionplasty (SS) procedure as treatment of osteoarthritis.
arm group label: Arthroscopic Trapeziectomy (AT)
description: Patients undergoing thumb basal joint arthroplasty using arthroscopic trapeziectomy (AT) procedure as treatment of osteoarthritis.
intervention type: Procedure
intervention name: Trapeziectomy with ligament reconstruction (I; LRTI)
description: Thumb basal joint arthroplasty (surgical) using Trapeziectomy with ligament reconstruction (I; LRTI)
arm group label: Ligament Reconstruction - Tendon Interposition (LRTI)
other name: NOTE: NO devices or drugs are included as part of this intervention.
intervention type: Procedure
intervention name: Trapeziectomy with suture suspensionplasty (II; SS)
description: Thumb basal joint arthroplasty (surgical) using Trapeziectomy with suture suspension-lastly (II; SS)
arm group label: Suture Suspensionplasty (SS)
other name: NOTE: NO devices or drugs are included as part of this intervention.
intervention type: Procedure
intervention name: Arthroscopic Trapeziectomy (III; AT)
description: Thumb basal joint arthroplasty (surgical) using Arthroscopic Trapeziectomy (III; AT)
arm group label: Arthroscopic Trapeziectomy (AT)
other name: NOTE: NO devices or drugs are included as part of this intervention.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
last name: Vincent D Pellegrini, MD
role: Principal Investigator
affiliation: Dartmouth-Hitchcock Medical Center
last name: Vincent D Pellegrini, MD
phone: (603) 650-5133
email: Vincent.D.Pellegrini.Jr@hitchcock.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Vincent D. Pellegrini
investigator title: Staff Physician, Orthopaedics
mesh term: Arthritis
mesh term: Osteoarthritis
sharing ipd: No