Ultra minimally invasive sonographically guided carpal tunnel release: an external pilot study

Area of Science:

• Orthopedic Surgery
• Minimally Invasive Procedures
• Musculoskeletal Disorders

Background:

• Carpal tunnel syndrome (CTS) surgery aims to reduce dissection for better outcomes.
• A novel sonographically guided ultra-minimally invasive carpal tunnel release (Ultra-MIS CTR) using a 1mm incision has been introduced.

Purpose of the Study:

• To assess the feasibility of a clinical trial comparing Ultra-MIS CTR with mini-open carpal tunnel release (Mini-OCTR).
• To evaluate safety, efficacy, recruitment rates, and other feasibility metrics for a future clinical trial.

Main Methods:

• A pilot study compared Ultra-MIS CTR (1mm incision) with Mini-OCTR (2cm incision).
• Feasibility was defined by meeting primary (safety, efficacy) and secondary objectives (recruitment, compliance, blinding, sample size).
• Quick-DASH scores and complication rates were primary outcomes; learning curve stability was assessed via turnover times.

Main Results:

• The pilot study met primary and secondary feasibility objectives.
• A sample size of 91 patients was calculated for the definitive clinical trial.
• Preliminary Quick-DASH scores favored Ultra-MIS CTR (14.54 vs 7.39), with lower complication rates (5% vs 20%).

Conclusions:

• A clinical trial comparing Ultra-MIS CTR and Mini-OCTR is feasible.
• Current evidence does not contraindicate or support withholding Ultra-MIS CTR for carpal tunnel syndrome.