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To evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation Medical Bioinductive Implant used as adjunct to surgical repair in the treatment of insertional Achilles tendonitis.
This is a prospective, non-randomized, single-arm study conducted under a common protocol designed to evaluate long-term outcomes following open treatment and implantation of the Rotation Medical Bioinductive Implant to treat insertional Achilles tendinopathy.
Up to 10 subjects will be enrolled and treated with the Rotation Medical Bioinductive Implant.
Enrollment is anticipated to take up to 12 months and all subjects will be followed for two years after surgery. Therefore, the overall study duration is estimated to be 36 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rotation Medical Bioinductive Implant
MedStar Union Memorial Hospital
Enrolling by invitation
Rotation Medical, Inc.
Published on BioPortfolio: 2016-06-23T19:08:22-0400
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