A Randomized Prospective Multicenter Study Comparing Suture Button Suspensionplasty (SBS) with Ligament Reconstruction and Tendon Interposition (LRTI)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
Canada
South Campus Research Unit for Bone and Soft Tissue
RECRUITING
Calgary
Fraser Orthopaedic Research Society
RECRUITING
New Westminster
Contact Information
Primary
Bertrand Perey
bperey@shaw.ca
604-553-3247
Time Frame
Start Date: 2022-06-20
Estimated Completion Date: 2026-05
Participants
Target number of participants: 138
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Fraser Orthopaedic Research Society