Tornier and LifeCell commence enrollment in Conexa Reconstructive Tissue Matrix clinical trial

Jan 28 2010

Tornier, Inc., a global leader in extremities and sports medicine orthopaedics, and LifeCell™ Corporation, a KCI Company (NYSE: KCI), announced today the first 13 patients have been enrolled in a multi-center clinical trial to document the clinical value of Conexa™ Reconstructive Tissue Matrix for the surgical repair of large rotator cuff tears. Conexa™ is a porcine-derived tissue matrix with both biologic and mechanical properties that are important to support the repair of injured or surgically reconstructed soft tissue. Launched by Tornier for orthopaedic applications in October of 2008, Conexa™ has been used successfully in approximately 1,500 patients.

“The clinical trial to investigate the potential benefits of Conexa represents a significant commitment from Tornier to support science-based clinical research. Dr. Iannotti and I look forward to working with leading shoulder surgeons nationally and internationally on this important project.”

The primary objective of the 65 patient, prospective Conexa™ clinical trial is to assess clinical outcomes following the surgical repair of large rotator cuff tears. In conjunction with these surgical procedures, Conexa™ is being utilized to reinforce the patient’s rotator cuff tissue that, especially in the case of large tears, may be atrophied or otherwise compromised. The primary clinical results of the study will be determined by comparing the pre-operative and post-operative measurements of functional metrics utilizing shoulder outcome scores. We will also be reviewing rotator cuff tissue healing using MRI images and shoulder strength. Study protocol and medical expert oversight are being provided by John Sperling, M.D. and Joseph Iannotti, M.D.

Dr. Sperling commented, “The clinical trial to investigate the potential benefits of Conexa represents a significant commitment from Tornier to support science-based clinical research. Dr. Iannotti and I look forward to working with leading shoulder surgeons nationally and internationally on this important project.”

Tears of the rotator cuff, the group of tendons and muscles that maintains the stability and range of motion of the shoulder, are among the most common of orthopaedic injuries. Large rotator cuff tears are especially challenging with research published in the Journal of Bone and Joint Surgery and other publications reporting re-tear rates that range from 29% to 94% and that increase dramatically with complicating factors such as advanced age, diabetes, and tobacco use. Patients with non-healed rotator cuff tears can face diminished function or permanent disability.