LRTI vs Internal Brace for CMC OA

NCT ID: NCT03971188

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-12-31

Brief Summary

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.

Conditions

Thumb Carpometacarpal Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internal Brace

Patients will undergo Internal Brace procedure for thumb CMC OA.

Group Type: EXPERIMENTAL

Trapeziectomy with Internal Brace

Intervention Type: PROCEDURE

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.

LRTI

Patients will undergo ligament reconstruction tendon interposition (most commonly performed surgery for thumb CMC OA) and serve as control group.

Group Type: ACTIVE_COMPARATOR

Trapeziectomy with Internal Brace

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Washington University & Barnes-Jewish Orthopedic Center in Chesterfield

St Louis, Missouri, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Barnes-Jewish Center for Advanced Medicine - South County

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

010216

Identifier Type: -

Identifier Source: org_study_id