LRTI vs Internal Brace for CMC OA

NCT03971188 | Completed Results

• 1 other identifier: 010216
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (3)

• Postoperative Follow-Up Retention Rate

  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

• VAS Pain Scores

  Visual Analog Scale (VAS) Pain 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.

  12 months

• Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores

  PROMIS 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. A higher score indicates better upper extremity function.

  12 months

Secondary Outcomes (13)

• Thumb Range of Motion: Thumb IP Joint Extension

  12 months

• Thumb Range of Motion: Thumb IP Joint Flexion

  12 months

• Thumb Range of Motion: Thumb MCP Joint Extension

  12 months

• Thumb Range of Motion: Thumb MCP Joint Flexion

  12 months

• Thumb Range of Motion: Thumb CMC Joint Palmar Abduction

  12 months

Study Arms (2)

Internal Brace

EXPERIMENTAL

Patients will undergo Internal Brace procedure for thumb CMC OA.

Procedure: Trapeziectomy with Internal Brace

LRTI

ACTIVE COMPARATOR

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

Interventions

Trapeziectomy with Internal Brace 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.

Internal Brace; LRTI

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (3)

Washington University & Barnes-Jewish Orthopedic Center in Chesterfield

St Louis, Missouri, 63017, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Barnes-Jewish Center for Advanced Medicine - South County

St Louis, Missouri, 63129, United States

Location

Limitations and Caveats

First, patients randomized to LRTI and STS participated in different postoperative rehab protocols, which may be a confounding factor in interpreting outcomes. Second, it was not possible to blind surgeons or patients to the procedures and rehab protocol, introducing potential bias. Third, the size of this initial RCT was not sufficient to balance confounding variables between groups. Finally, our cohort was underpowered to detect statistically significant differences in outcome measures.

Results Point of Contact

• Title: Dr. Charles Goldfarb
• Organization: Washington University in St. Louis

goldfarbc@wustl.edu

(314) 362-3768

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: June 3, 2019
• Study Start: January 1, 2020
• Primary Completion: August 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 6, 2025
• Results First Posted: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)