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Achilles Non-SNIS REGENETEN
Sponsor: OrthoCarolina Research Institute, Inc.
Summary
The proposed study addresses this gap by prospectively evaluating patient-reported outcomes, imaging endpoints, and safety through 12 months after BCI-augmented repair in IAT and MSR patients. The purpose is to evaluate clinical outcomes (effectiveness) following the use of REGENETEN to augment Achilles tendon surgical procedures.
Key Details
Gender
All
Age Range
21 Years - 70 Years
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2026-08-03
Completion Date
2028-12-31
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
REGENETEN
The REGENETEN Bioinductive Implant is a scaffold made from highly purified type I collagen fibers. Following fixation, using its efficient and suture-free technique, the REGENETEN Implant is resorbed and replaced by a new layer of tendon-like tissue within 6 months increasing tendon thickness, and creating an environment conducive to healing.
Locations (1)
OrthoCarolina Research Institute
Charlotte, North Carolina, United States