Study Comparing SBS and LRTI for Treatment of CMC Arthritis

Study Overview
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Brief Summary
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A multi-center, randomized control trial comparing the two standard of care surgical treatments for CMC arthritis ; trapezial excision with or without soft tissue interposition and /or ligament reconstruction (LRTI) versus the suture button suspension arthroplasty (SBS). Patient reported outcomes will be collected at 6 and 6 weeks, 3, 6, and 12 months.

Detailed Description
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LRTI is a well established treatment of CMC arthritis with good results.However, comparable results have also been reported with SBS, with the latter procedure eliminating the need for flexor carpi radialis (FCR) harvest and interposition, resulting in potential shorter OR time and donor site morbidity. To date, there have been biomechanical studies comparing LRTI vs suture button suspension arthroplasty (SBS), and clinical studies comparing trapeziectomy alone vs SBS, but to the best of our knowledge, no random control studies comparing LRTI with SBS.The primary objective is to determine whether treatment with SBS results in improved overall pain relief compared to LRTI as measured by patient reported outcomes.Secondary outcome measures will be to determine if SBS results in shorter OR time and improved grip and pinch strength compared to LRTI, as well as have comparable return to work times and amount of radiographic shortening as shown on radiographs (metacarpal shortening has been felt to lead to decreased grip strength).

Official Title
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A Randomized Prospective Multicenter Study Comparing Suture Button Suspensionplasty (SBS) With Ligament Reconstruction and Tendon Interposition (LRTI)

Conditions
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Arthritis

Intervention / Treatment
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* Procedure: CMC Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age fifty years or older Isolated carpometacarpal (trapeziometacarpal) osteoarthritis Failure to respond to non-operative management Willing and able to consent on their own behalf and follow the protocol and clinical visits as described Able to read and understand English or have interpreter available Exclusion Criteria: Previous surgery for CMC arthritis Duration of symptoms for less than 6 months Greater than or equal to 30 degrees of ipsilateral metacarpophalangeal (MCP) hyperextension Scaphotrapeziotrapezoidal (stage 4 CMC) arthritis Other significant ipsilateral wrist or hand pathology A history of inflammatory arthropathy A requirement for concomitant surgery for another condition Any previous hand or wrist fracture Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged patients without adequate support, etc.)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Multicenter, randomized, prospective trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Trapezial excision with or without soft tissue interposition and /or ligament reconstruction<br>The participating surgeon will perform their usual version of a trapeziectomy and thumb metacarpal using either FCR tendon or abductor hallucis longs (APL) tendon. Tendon interposition will be left to the surgeon's discretion. | Procedure: CMC Arthroplasty<br>* Surgical intervention to treat CMC arthritis<br>|
| Other: Suture button suspension arthroplasty (SBS)<br>Dorso-radial incision, capsulotomy between extensor pollicis brevis (EPB) and APL protecting the radial artery. A second incision is made on dorsum of hand between the 2nd and 3rd MCs. A cannulated drill with suture passer is passed from base of 1st MC to mid 2nd MC. The TightropeTM is passed from 1st to second MC with one button on the base of the 1st MC. Trapeziectomy is then performed using a cruciate osteotomy and rongeurs. The thumb is adducted against index MC to avoid excessive tightening and the suture is tied over a second button on the 2nd MC. Closure of capsule with Vicryl. Closure of skin with running Prolene suture. | Procedure: CMC Arthroplasty<br>* Surgical intervention to treat CMC arthritis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale- Pain | Participants overall assessment of their pain at maximal key pinch loading on a 10 cm visual analogue scale | 12 Months | 
| Disabilities of the Arm, Shoulder and Hand Questionnaire | A 30 Item questionnaire that measures an individuals' ability to complete tasks, absorb forces and severity of symptoms. Lower scores will indicated better outcomes.Lower scores will indicate better outcomes. | 12 Months | 
| Patient Related Wrist Evaluation Questionnaire | A 15 item questionnaire to measure wrist pain and disability pain in activities of daily living | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time | Time as recorded from the surgeons start of the procedure until the surgeons stop. | Intraoperative | 
| Strength | Transverse volar grip strength as measured by a dynamometer and key and lateral pinch strength measure by a pinch gauge | 12 Months | 
| Range of Motion | Thumb flexion will be measured from the top of the thumb (pulp) to the base of the 5th metacarpal (pinky finger). Retropulsion measured as the distance between the thumb and table when the dorsum of the hand is pressed against the table. | 12 Months | 
| Work Productivity and Activity Impairment: Specific Health Problem Questionnaire | A questionnaire pertaining to the effect of the participant's CMC arthritis on their ability to work and perform regular activities. Lower scores will indicate better outcomes. | 12 Months |