Fraser Orthopaedic Research Society
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.
Arthritis
CMC Arthroplasty
Not Applicable
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).}}
| Study Type : | Interventional |
| Estimated Enrollment : | 138 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Treatment |
| Official Title : | A Randomized Prospective Multicenter Study Comparing Suture Button Suspensionplasty (SBS) With Ligament Reconstruction and Tendon Interposition (LRTI) |
| Actual Study Start Date : | June 20, 2022 |
| Estimated Primary Completion Date : | December 2024 |
| Estimated Study Completion Date : | May 2025 |
| Arm | Intervention/treatment |
|---|---|
|
Other: Trapezial excision with or without soft tissue interposition and /or ligament reconstruction 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 |
|
Other: Suture button suspension arthroplasty (SBS) 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 |
| Ages Eligible for Study: | 50 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
South Campus Research Unit for Bone and Soft Tissue
Calgary, Alberta, Canada, 1m4
Recruiting
Fraser Orthopaedic Research Society
New Westminster, British Columbia, Canada, V3L 0E4