Arthritis
Conditions
Brief 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).
Interventions
PROCEDURECMC Arthroplasty
Surgical intervention to treat CMC arthritis
Sponsors
Fraser Orthopaedic Research Society
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter, randomized, prospective trial.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Exclusion criteria
* 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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale- Pain | 12 Months | Participants overall assessment of their pain at maximal key pinch loading on a 10 cm visual analogue scale |
| Disabilities of the Arm, Shoulder and Hand Questionnaire | 12 Months | A 30 Item questionnaire that measures an individuals' ability to complete tasks, absorb forces and severity of symptoms. Lower scores will indicated better outcomes.Lower scores will indicate better outcomes. |
| Patient Related Wrist Evaluation Questionnaire | 12 Months | A 15 item questionnaire to measure wrist pain and disability pain in activities of daily living |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | Intraoperative | Time as recorded from the surgeons start of the procedure until the surgeons stop. |
| Work Productivity and Activity Impairment: Specific Health Problem Questionnaire | 12 Months | A questionnaire pertaining to the effect of the participant's CMC arthritis on their ability to work and perform regular activities. Lower scores will indicate better outcomes. |
| Strength | 12 Months | Transverse volar grip strength as measured by a dynamometer and key and lateral pinch strength measure by a pinch gauge |
| Range of Motion | 12 Months | Thumb flexion will be measured from the top of the thumb (pulp) to the base of the 5th metacarpal (pinky finger). Retropulsion measured as the distance between the thumb and table when the dorsum of the hand is pressed against the table. |
Countries
Canada
Contacts
Primary ContactBertrand Perey
Outcome results
None listed