Clinical trial NCT03971188: LRTI vs Internal Brace for CMC OA
Official title: Ligament Reconstruction Tendon Interposition Versus Internal Brace for the Surgical Treatment of Thumb Carpometacarpal Arthritis: a Prospective Randomized Trial Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thumb Carpometacarpal Osteoarthritis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 31
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Postoperative Follow-Up Retention Rate
timeFrame: 12 months
measure: VAS Pain Scores
timeFrame: 12 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores
timeFrame: 12 months
Secondary outcomes:
measure: Thumb Range of Motion: Thumb IP Joint Extension
timeFrame: 12 months
measure: Thumb Range of Motion: Thumb IP Joint Flexion
timeFrame: 12 months
measure: Thumb Range of Motion: Thumb MCP Joint Extension
timeFrame: 12 months
measure: Thumb Range of Motion: Thumb MCP Joint Flexion
timeFrame: 12 months
measure: Thumb Range of Motion: Thumb CMC Joint Palmar Abduction
timeFrame: 12 months
measure: Thumb Range of Motion: Thumb CMC Joint Palmar Adduction
timeFrame: 12 months
measure: Thumb Range of Motion: Thumb CMC Joint Radial Abduction
timeFrame: 12 months
measure: Thumb Range of Motion: Thumb CMC Joint Radial Adduction
timeFrame: 12 months
measure: Grip Strength
timeFrame: 12 months
measure: Pinch Strength: Lateral Pinch
timeFrame: 12 months
measure: Pinch Strength: Three-Point Pinch
timeFrame: 12 months
measure: Thumb Metacarpal Radiographic Subsidence: Trapezial Space Ratio Reduction
timeFrame: 12 months
measure: Return to Work/Activity
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University & Barnes-Jewish Orthopedic Center in Chesterfield
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Center for Advanced Medicine - South County
state: Missouri
Study officials:
References: