LRTI vs Internal Brace for CMC OA

January 27, 2023 updated by: Washington University School of Medicine

Ligament Reconstruction Tendon Interposition Versus Internal Brace for the Surgical Treatment of Thumb Carpometacarpal Arthritis: a Prospective Randomized Trial Pilot Study

Carpometacarpal osteoarthritis (CMC OA) is a prevalent and disabling disease. Trapeziectomy with ligament reconstruction and tendon interposition (LRTI), the most frequently performed procedure for CMC OA, requires prolonged postoperative immobilization which limits patients' abilities to perform Activities of Daily Life (ADLs) and to work. Trapezium excision and internal brace (IB) stabilization is a largely unstudied novel alternative to LRTI which has demonstrated encouraging short-term clinical outcomes and allows an expedited return to work/activity. In this feasibility and pilot grant application, our overall objective is to investigate critical questions to inform the planning of a definitive randomized controlled trial (RCT) comparing IB and LRTI for patients with CMC OA. Our central hypothesis is that a prospective RCT comparing LRTI and IB is feasible, and that IB will produce superior patient-reported outcomes to LRTI at 6 weeks and 3 months with an expedited return to work/activity. Our specific aims are to (1) Establish feasibility of a definitive trial by determining the proportion of eligible subjects who agree to randomized treatment and determining the follow-up retention rate, (2) Estimate effect sizes and variability in outcomes for planning a definitive RCT, and (3) Characterize objective clinical outcomes (thumb range of motion, grip/pinch strength, radiographic outcomes, complications/need for additional surgery, and cost) and to identify differences in return to work/activity following IB and LRTI. To achieve the study's aims, the investigators will randomize 50 patients as they present to the clinics of the 7 Washington University Orthopaedic Hand surgeons to LRTI (control) or IB (experimental). Patients will follow-up at 2 weeks, 4 weeks, 3 months, and 1 year post-operatively. Primary outcomes will be feasibility (randomization rate, follow-up retention rate), and PROMIS scores at 6 weeks and 3 months. Secondary outcomes will be objective clinical outcomes and return to work/activity. Upon completion of the study's aims, the investigators expect to demonstrate that a prospective, randomized trial comparing ligament reconstruction and tendon interposition (LRTI) and internal brace (IB) is feasible, and that patients who undergo IB will have superior short-term patient-reported outcomes to those who undergo LRTI. Furthermore, the study will generate effect size and variability estimates for a definitive, subsequent randomized controlled trial (RCT). Should the objectives for this study be successful, the IB procedure may be readily incorporated into the Hand surgeon's armamentarium as a viable option for the treatment of CMC OA, and the study will provide essential data to support informed, shared decision-making among patients and their physicians.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
      • Saint Louis, Missouri, United States, 63017
        • Washington University & Barnes-Jewish Orthopedic Center in Chesterfield
      • Saint Louis, Missouri, United States, 63129
        • Barnes-Jewish Center for Advanced Medicine - South County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >50
  • Isolated treatment of CMC arthritis
  • No carpal tunnel syndrome (to avoid outcome data confusion)

Exclusion Criteria:

  • Patients with thumb metacarpophalangeal hyperextension being addressed surgically
  • Patients with concurrent rheumatoid arthritis/inflammatory arthritis
  • Patients with history of chronic opioid use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Internal Brace
Patients will undergo Internal Brace procedure for thumb CMC OA.
Procedure: Trapeziectomy with Internal Brace
Trapeziectomy is performed in standard fashion. Longitudinal traction applied to thumb. Suture anchor with suture tape is inserted into drill hole at radial thumb metacarpal base. A second suture anchor is inserted into a drill hole at the radial base of the index metacarpal such that the suture tape suspends the thumb at the natural groove. Thumb position and tension assessed.
ACTIVE_COMPARATOR: LRTI
Patients will undergo ligament reconstruction tendon interposition (most commonly performed surgery for thumb CMC OA) and serve as control group.
Procedure: Trapeziectomy with Internal Brace
Trapeziectomy is performed in standard fashion. Longitudinal traction applied to thumb. Suture anchor with suture tape is inserted into drill hole at radial thumb metacarpal base. A second suture anchor is inserted into a drill hole at the radial base of the index metacarpal such that the suture tape suspends the thumb at the natural groove. Thumb position and tension assessed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Randomization rate
Time Frame: 12 months
The investigators will establish feasibility of a definitive trial by determining the proportion of eligible subjects who agree to randomized treatment and determining follow-up retention rate.
12 months
Follow-up retention rate
Time Frame: 12 months
The investigators will establish feasibility of a definitive trial by determining the proportion of eligible subjects who agree to randomized treatment and determining follow-up retention rate.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity and Physical Function scores
Time Frame: 12 months
PROMIS Physical Function and Upper Extremity scores will be collected at all clinic visits on iPad as per standard protocol for all patients presenting to a Washington University Orthopaedic Surgery clinic. These scores will be compared pre-op and at 2 weeks, 4 weeks, 3 months, and 1 year post-op. All PROMIS domain scores are normalized to a mean score of 50 and standard deviation of 10 intending to minimize floor and ceiling effects and ensure the results are readily understood and communicated. Higher scores on all PROMIS Computer Adaptive Tests (CATs) indicate more of the domain measured such that higher scores on Physical Function are associated with greater function. The Upper Extremity and Physical Function scores will be reported independently, and will not be summed.
12 months
Visual Analog Scale (VAS) Pain and Satisfaction scores
Time Frame: 12 months
Visual Analog Scale Pain and Satisfaction scores will be collected by a member of our team at all visits. These scores will be compared pre-op and at 2 weeks, 4 weeks, 3 months, and 1 year post-op. Scale ranges from 0 to 10 points. For Pain, 0 indicates no pain and 10 indicates maximum pain. For Satisfaction, 0 indicates most unsatisfied and 10 indicates most satisfied.
12 months
Thumb Range of Motion (ROM)
Time Frame: 12 months
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
12 months
Grip Strength
Time Frame: 12 months
The investigators will record pinch and grip strength PRE-OP and POST-OP (all visits except 2 weeks post-op) in both the operative and contralateral hands. Pinch strength will be measured using a pinch gauge and recorded in kilograms. For pinch, the investigators will record "lateral/key pinch" AND "3-point pinch". Grip strength will be measured using dynamometer and recorded in kilograms.
12 months
Pinch Strength
Time Frame: 12 months
The investigators will record pinch and grip strength PRE-OP and POST-OP (all visits except 2 weeks post-op) in both the operative and contralateral hands. Pinch strength will be measured using a pinch gauge and recorded in kilograms. For pinch, the investigators will record "lateral/key pinch" AND "3-point pinch". Grip strength will be measured using dynamometer and recorded in kilograms.
12 months
Radiographic Subsidence of Thumb Metacarpal
Time Frame: 12 months
Posteroanterior wrist and Roberts view C-arm XRs from pre-op, 3 months post-op, and 1 year post-op will be obtained. Subsidence of the thumb metacarpal will be measured in millimeters and compared between the two groups.
12 months
Complications
Time Frame: 12 months
Complications will recorded at all time points post-op and will be tracked as binary (yes/no). There will be 3 levels of severity- mild, moderate, and severe. Mild- minor clinical significance (i.e., scar tenderness or sensory disturbances). Moderate- clinically relevant with delay in patient recovery, but not severe enough to necessitate revision surgery and resolved 12 months post-op (i.e., mild Complex Regional Pain Syndrome type I, tendinitis, neuromas treated with steroid injections). Severe- result in revision surgery, pain at rest, or impaired hand function at 12 month exam (i.e., severe Complex Regional Pain Syndrome type I or tendinitis and neuromas that did not improve with corticosteroid injections and required surgery). Complications will be compared between the two treatment groups.
12 months
Return to Work/Activity
Time Frame: 12 months
The investigators will track return to work/activity by asking patients at each follow-up visit (1) IF they have returned to their work and baseline activity, and (2) if so, HOW LONG AFTER THEIR SURGERY did they return (ie, 2 weeks, 4 weeks, 6 weeks, 2 mos, 2.5 mos, 3 mos, 4 mos, 5 mos, >6 mos). Return to work and activity will be compared between the two treatment groups.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

June 30, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

May 29, 2019

First Posted (ACTUAL)

June 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 27, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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