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)
Fraser Orthopaedic Research Society
138 participants
Jun 20, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria9
- 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.)
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Surgical intervention to treat CMC arthritis
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05111405