Dionigi Lorusso, Aurore Giliberti, Margherita Bianco and Gioacchino
Study design
To evaluate the role played by the Layershield matrix (L.S.M.) in avoiding scar tissue and adhesion of the median nerve after decompression in carpal tunnel syndrome.
Objective
Prospective randomized trial to examine this technique. The idea was to investigate the potential benefits when dealing with complications (adherence of the flexor tendons and severing or scarring of the median nerve using the twoinch matrix as an adhesion barrier following mini-open carpal tunnel release).
Summary of background
The study cohort (L.S.M group) consisted of consecutive patients (200 patients) treated with L.S.M. Patients in the standard procedure group (200 patients in all) underwent operations using the same technique in carpal tunnel surgery in both groups, completing follow-up evaluations at no less than 3 to 6 months post-operation. The male to female ratio was 1:6. In twenty patients, there was bilateral involvement.
Method
All operations were conducted by the author at the Hospital General Universitario de Valencia, and the Clínica La Salud, Valencia, Spain, between 2012 and 2013. All patients complained of numbness and/or sensory disturbance or weakness in the median nerve distribution of the hand. Tinel and Phalen sign tests were positive in about two-thirds of patients. EMG studies were performed in all patients and were positive, ranging from mild to severe.
Results
Numbness and paresthesia were relieved in 95% of patients in the L.S.M. group and 89% in the control group (CG). Pain was relieved in 95% DG and 90% CG. Motor weakness was relieved in 95% DG and 92% CG. Normal grip strength was evident in 93% DG and 91% had normal pinch strength.
Re-operation rate
Adherence of the flexor tendons in 3 CG patients and 8 patients due to scarring involving the median nerve, with the L.S. matrix group undergoing re-operation for the following reasons: recurrent pain (3 patients due to scarring around the median nerve). The difference in the re-operation rate between the collagen matrix group and the standard procedure group is statistically significant (p<0.01).
Conclusion
Findings in this study (reduced pain and lower incidence of adhesions) are consistent with the L.S. matrix acting as an effective adhesion barrier. By preventing median nerve adhesions, the L.S. matrix may significantly reduce the incidence of disabling pain associated with re-operation. Ultimately, the prophylactic use of the Layershield Matrix to prevent adhesions may result in improved patient outcomes.
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