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Achilles Tendon Repair With Bioinductive Implant

2016-06-23 19:08:22 | BioPortfolio

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.

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 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Tendinopathy

Intervention

Rotation Medical Bioinductive Implant

Location

MedStar Union Memorial Hospital
Baltimore
Maryland
United States
21218

Status

Enrolling by invitation

Source

Rotation Medical, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-06-23T19:08:22-0400

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