NCT02811003

Achilles Tendon Repair With Bioinductive Implant

Evaluation of the Rotation Medical Bioinductive Implant for Insertional Achilles Tendinopathy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 20 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.

Conditions

• Tendinopathy

Interventions

Type	Name	Description
DEVICE	Rotation Medical Bioinductive Implant	Placement of bioinductive implant over repair of insertional Achilles tendinopathy

Timeline

• Start date: 2016-06-03
• Primary completion: 2019-09-17
• Completion: 2019-09-17
• First posted: 2016-06-23
• Last updated: 2022-11-04
• Results posted: 2022-11-04

Locations

2 sites across 1 country: United States