NCT05111405

Study Comparing SBS and LRTI for Treatment of CMC Arthritis

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Fraser Orthopaedic Research Society · Network
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

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).

Conditions

• Arthritis

Interventions

Type	Name	Description
PROCEDURE	CMC Arthroplasty	Surgical intervention to treat CMC arthritis

Timeline

• Start date: 2022-06-20
• Primary completion: 2026-02-01
• Completion: 2026-05-01
• First posted: 2021-11-08
• Last updated: 2025-02-28

Locations

2 sites across 1 country: Canada