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Compares treatment options for Arthritis
Official title Study Comparing SBS and LRTI for Treatment of CMC Arthritis
ClinicalTrials.gov ID: NCT05111405
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- New Westminster, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; New Westminster, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.