Tornier, a developer and marketer of orthopaedic medical devices, and LifeCell, a subsidiary of KCI, have reported that the first 13 patients have been enrolled in a multi-center clinical trial to document the clinical value of Conexa. Its a reconstructive tissue matrix used for the surgical repair of large rotator cuff tears.
Conexa is a sterile medical device with a sterility assurance level of 10-6. It is a porcine-derived tissue matrix, with both biologic and mechanical properties that support the repair of injured or surgically reconstructed soft tissue. Conexa has been launched by Tornier for orthopaedic applications in October 2008.
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 utilised to reinforce the patient’s rotator cuff tissue that, especially in the case of large tears, may be atrophied or otherwise compromised, said the company.
The primary clinical results of the study will be determined by comparing the pre-operative and post-operative measurements of functional metrics, utilising shoulder outcome scores. The rotator cuff tissue healing using MRI images and shoulder strength will also be reviewed. Study protocol and medical expert oversight are being provided by John Sperling and Joseph Iannotti.
Dr. Sperling said: “The clinical trial to investigate the potential benefits of Conexa represents a 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 project.”