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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
Surgical intervention to treat CMC arthritis
South Campus Research Unit for Bone and Soft Tissue
Calgary, Alberta, Canada
RECRUITINGFraser Orthopaedic Research Society
New Westminster, British Columbia, Canada
RECRUITINGVisual Analog Scale- Pain
Participants overall assessment of their pain at maximal key pinch loading on a 10 cm visual analogue scale
Time frame: 12 Months
Disabilities of the Arm, Shoulder and Hand Questionnaire
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.
Time frame: 12 Months
Patient Related Wrist Evaluation Questionnaire
A 15 item questionnaire to measure wrist pain and disability pain in activities of daily living
Time frame: 12 Months
Operative Time
Time as recorded from the surgeons start of the procedure until the surgeons stop.
Time frame: Intraoperative
Strength
Transverse volar grip strength as measured by a dynamometer and key and lateral pinch strength measure by a pinch gauge
Time frame: 12 Months
Range of Motion
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.
Time frame: 12 Months
Work Productivity and Activity Impairment: Specific Health Problem Questionnaire
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 Months