CompletedNot Applicable

Achilles Tendon Repair With Bioinductive Implant

United States20 participantsStarted 2016-06-03

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. At least 21 years of age
✓. Insertional Achilles tendonitis requiring surgery that has failed conservative management, which consist of:
✓. Chronic Achilles tendon pain lasting longer than 3 months
✓. MRI or X-ray of the ankle within 60 days prior to the study procedure
✓. Willing to comply with the prescribed post-operative rehabilitation program
✓. Willing to be available for each protocol-required follow-up examination
✓. Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures
✓. Ability to read, understand, and complete subject-reported outcomes in English

Exclusion criteria

✕. Achilles tendon rupture
✕. Previous Achilles tendon surgery on the index ankle
✕. Genetic collagen disease
✕. History of auto-immune or immunodeficiency disorders
✕. History of chronic inflammatory disorders
✕. Oral steroid use in last 2 months or injectable steroid use in last 4 weeks
✕. History of heavy smoking (\> 1 pack per day) within last 6 months
✕. Hypersensitivity to bovine-derived materials

What they're measuring

New Tissue Thickness

Timeframe: 3, 12, and 24 months

MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue)

Timeframe: 3, 12, and 24 months

Tear Rate

Timeframe: following surgery to end of treatment at 24 months

Trial details

NCT IDNCT02811003

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09-17

Results submitted2022-07-26

View on ClinicalTrials.gov More Tendinopathy trials