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 5, 2011 |
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Objective: To prevent frequent complications linked to adherences and fibrosis formed after orthopaedic surgery, several solutions have been tested to decrease their incidences: medical treatments, cover flaps and more recently, use of biomaterials. Local flaps may be beneficial but results are often unpredictable.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 orthopaedic surgery, moreover after trauma, the lack of validated biomaterials often leads to re-intervention for neurolysis and/or tenolysis. 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 composed at a 100% 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. Sixteen patients, mean age 50y.o., 8 females and 8 males were included for 7 tenolysis of extensors and 9 neurolysis. Before the 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, 7 excellent or good results were found after extensor tendon tenolysis and 8 excellent or good results after neurolysis. One patient obtained a fair result after a 4th neurolysis of a transposed ulnar nerve.
Conclusion: Authors report 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 after neurolysis and tenolysis. These first results show a significant reduction of previous irritative syndromes and a recovery of mobility in each case. 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.