OrthoCarolina Research Institute, Inc.
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.
Achilles tendon pathology is a common musculoskeletal condition, affecting approximately 6% of the general population. Mid substance ruptures (MSR) have a reported incidence rate of approximately 2.1 per 100000 people, and one third of all instances of Achilles tendon pain have been attributed to Insertional Achilles tendinopathy (IAT). Although patients undergoing standard of care repair of MSR generally report good clinical outcomes, and re-rupture rates following primary repair of a mid-substance tear are cited to range 2-3%, the timeframe for returning to activity can be upwards of 6-8 mo…
Inclusion Criteria: Acute Mid-Substance Rupture: * Clinical diagnosis of complete mid-portion Achilles rupture by experienced physician (Diagnosis confirmation to include presence of positive Thompson test) * Adult patients ≥21 to 70 years old * Acute rupture (≤14 days of initial injury) * Rupture located 2-6cm proximal to calcaneal insertion mid portion * Indicated for surgical procedure Insertional Achilles Tendinopathy: * Diagnosis of insertional Achilles tendinopathy confirmed by imaging and having failed at least 3 months of conservative management. * Adult patients ≥21 to 70 years ol…
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.
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