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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Thumb Range of Motion: Thumb IP Joint Extension
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
Time frame: 12 months
Thumb Range of Motion: Thumb IP Joint Flexion
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
Time frame: 12 months
Thumb Range of Motion: Thumb MCP Joint Extension
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
Time frame: 12 months
Thumb Range of Motion: Thumb MCP Joint Flexion
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
Time frame: 12 months
Thumb Range of Motion: Thumb CMC Joint Palmar Abduction
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
Time frame: 12 months
Thumb Range of Motion: Thumb CMC Joint Palmar Adduction
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
Time frame: 12 months
Thumb Range of Motion: Thumb CMC Joint Radial Abduction
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
Time frame: 12 months
Thumb Range of Motion: Thumb CMC Joint Radial Adduction
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups.
Time frame: 12 months
Grip Strength
The investigators will record grip strength PRE-OP and POST-OP (all visits except 2 weeks post-op) in both the operative hands. Grip strength will be measured using dynamometer and recorded in pounds (lbs).
Time frame: 12 months
Pinch Strength: Lateral Pinch
The investigators will record pinch strength PRE-OP and POST-OP (all visits except 2 weeks post-op) in the operative hand. Pinch strength will be measured using a pinch gauge and recorded in pounds (lbs). For pinch, the investigators will record "lateral/key pinch" AND "3-point pinch."
Time frame: 12 months
Pinch Strength: Three-Point Pinch
The investigators will record pinch strength PRE-OP and POST-OP (all visits except 2 weeks post-op) in the operative hand. Pinch strength will be measured using a pinch gauge and recorded in pounds (lbs). For pinch, the investigators will record "lateral/key pinch" AND "3-point pinch."
Time frame: 12 months
Thumb Metacarpal Radiographic Subsidence: Trapezial Space Ratio Reduction
Posteroanterior wrist and Roberts view C-arm XRs from pre-op, 3 months post-op, and 1 year post-op were obtained. Thumb metacarpal subsidence was calculated using the trapezial space ratio (TSR) measured on a posteroanterior wrist radiograph.
Time frame: 12 months
Return to Work/Activity
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.
Time frame: 12 months
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