NERVES
CONDUCT
RCT: denervation versus trapeziectomy in CMC1 OA
Inclusion to be started
Background:
Thumb carpometacarpal (CMC-1) osteoarthritis is a common condition that may result in severe, function-limiting pain despite maximal conservative treatment. Trapeziectomy is the current standard surgical treatment but is associated with prolonged recovery and substantial healthcare costs. Denervation of the CMC-1 joint may offer a less invasive alternative with faster recovery.
Objective:
To determine whether CMC-1 joint denervation is non-inferior to trapeziectomy in reducing pain at 1 year postoperatively in patients with radiographically confirmed CMC-1 osteoarthritis and disabling pain despite maximal conservative management.
Hypothesis:
CMC-1 joint denervation will result in non-inferior pain reduction compared with trapeziectomy, with faster recovery, lower costs, improved pinch strength, and non-inferior improvements in function and range of motion.
Methods:
This open-label, multicenter, parallel-group randomized controlled trial employs a non-inferiority design. Adult patients with radiographic CMC-1 osteoarthritis and disabling pain refractory to conservative treatment will be randomized to either CMC-1 joint denervation or trapeziectomy. The primary outcome is between-group difference in pain at 1 year, measured using the Numeric Rating Scale. Secondary outcomes include functional recovery, quality of life, healthcare utilization, and productivity-related costs.
Statistical Analysis:
Accounting for a 10% loss to follow-up, a total of 144 patients (72 per group) will be included. The primary outcome will be analyzed using a linear mixed-effects model with treatment group as a fixed effect and participating center as a random effect.
Economic Evaluation:
Incremental medical and societal costs will be assessed to evaluate the cost-effectiveness and budget impact of CMC-1 joint denervation compared with trapeziectomy.
Timeline:
Study preparation (months 1–5), patient inclusion (months 6–30), follow-up (months 31–42), and data analysis and reporting (months 43–48).
