Article
Evaluation of a new collagen membrane (Cova™ ORTHO) in guided tissue regeneration for tenolysis or neurolysis in upper limb surgery. Preliminary results
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Published: | October 9, 2012 |
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Outline
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Objective: To prevent frequent complications linked to adherences and fibrosis formed after orthopaedic surgery, medical treatments, cover flaps and more recently, use of biomaterials have been tested to decrease their incidences. Biomaterials, especially membranes can be interposed between the injured and surrounding tissues to avoid contact and formation of the fibrin bridge after surgery on nerves and/or tendons. In this study, we evaluate the efficiency and tolerance of a new membrane designed to guide the healing process and prevent adherences.
Methods: The membrane (Cova™ ORTHO, Biom’Up, France) is only composed of collagen. Most patients involved required secondary surgery after the initial post trauma surgical procedure for neurolysis or tenolysis. The wet collagen membrane (immersed in physiological serum) was tested by beeing placed around the liberated tissues to ensure protection and avoid adherence formation. 56 patients, mean age 49 y.o., 21 females and 35 males were included for 16 tenolysis and 40 neurolysis. Before surgery, all patients had severe chronic pain with irritative syndrome and/or stiffness of the affected joints. Surgery constantly consisted in the liberation of nerves and/or tendons involved in the adherence and in the protection of the tissue by the collagen membrane.
Results: No allergic or unwanted inflammatory response was observed. After 2 to 11 months, 12 excellent or good results were found after tendon tenolysis. We noted an increase of 38% of active total range of motion (ROM) and of 22% for passive total ROM. After neurolysis, good or excellent results were obtained in 75% of patients. The irritative syndrome was totally resolved in 53% of cases and reduced in 35%. The Quick Dash was improved of 14 points. Paresthesis disappeared in 30% cases and were reduced in 45%.
Conclusion: The preliminary results of a prospective clinical study performed to assess the efficiency and tolerance of a new collagen membrane in the prevention of postsurgical adherence formation and in the guidance of tissue regeneration show a significant reduction of previous irritative syndromes and a recovery of mobility after neurolysis and tenolysis. No adverse event was reported. In some cases, we can also recommend the use of this collagen membrane Cova™ ORTHO for specific pluritissular lesions in emergency procedures.