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A Comparison of the Adhesion Reduction Efficacy of ACI-Maix and Tenoglide™ in Primary Flexor Tendon Repair
John Bradley Turner, MD1; Rubina L. Corazzini, BS2; Timothy J. Butler, BS2; David S. Garlick, DVM, DACVP3; Brian Rinker, MD1
1Division of Plastic Surgery, University of Kentucky, Lexington, KY; 2Department of Biomaterials Science and Engineering, Genzyme Corporation, Cambridge, MA; 3Department of Pathology, Histo-Scientific Research Laboratories, Mount Jackson, VA

Introduction: The prevention of peritendinous adhesions following Zone II flexor tendon repair remains an elusive objective in hand surgery.  Many modalities have been employed with varying results.  The use of commercially available mechanical barriers remains a practical option though the most ideal entity remains to be discovered. Two collagen-based materials were evaluated in this study: ACI-Maix Collagen membrane, a product derived of purified porcine Type I/III collagen and TenoGlide Tendon Protector Sheet, a product of cross linked bovine Type I collagen and glycosaminoglycan.

Methods: A standardized flexor tendon laceration and repair was performed in toes 2, 3 and 4 of adult female Leghorn chickens (n=18).  Toes were randomized to one of 3 repair types (1) ACI-Maix Collagen membrane (n=18), (2) TenoGlide Tendon Protector Sheet (n=18), or (3) untreated control (n=18).  On postoperative day 21 the animals were sacrificed and the repair sites were evaluated histologically. Blinded qualitative and semi-quantitative evaluations were performed with the extent of peritendinous adhesions rated on a 4-point scale (none, minimal, mild, moderate, and marked) and the nature of tendon healing rated on a 3-point scale (excellent, good, fair, poor) based on previously published scoring schema.  Groups were compared using chi-square analysis.

Results: Our analysis demonstrated statistically significant improvements in the degree of peritendinous adhesions relative to untreated controls for both the ACI-Maix and TenoGlide groups.  The ACI-Maix group demonstrated mild or lesser degree of adhesions as defined by a 4-point evaluation scale in 94% (p<0.05) of those analyzed.  In the TenoGlide group 100% of sites were characterized as having mild or lesser adhesions (p<0.05).  In the control tendons, 0% of sites were described as mild or lesser adhesions.  With regard to the nature of tendon healing, ACI-Maix demonstrated 50% and TenoGlide demonstrated 64% scores of good or excellent relative to 0% in the untreated control group.  There were no statistically significant differences between the ACI-Maix and TenoGlide groups in regards to either peritendinous adhesion or tendon healing.  There was a mild to marked inflammatory response to the ACI-Maix Collagen membrane relative to the TenoGlide and control groups.  ACI-Maix had more favorable surgical handling characteristics.

Discussion: Both ACI-Maix and TenoGlide demonstrate statistically significant reduction in the degree of peritendinous adhesions as well as improvement in overall tendon healing compared to untreated tendon repairs.  Collagen-based barriers may be a useful adjunct to standard repair and rehabilitation protocols to reduce postoperative tendon adhesions and improve clinical outcomes.

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