Achilles Tendon Repair With Bioinductive Implant

Smith & Nephew

Status: Completed

Conditions: Tendinopathy

Treatments: Device: Rotation Medical Bioinductive Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02811003

3672-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. At least 21 years of age

2. Insertional Achilles tendonitis requiring surgery that has failed conservative management, which consist of:

   A. Shoe modification B. Nonsteroidal anti-inflammatory drugs C. Physical Therapy with/without modalities

3. Chronic Achilles tendon pain lasting longer than 3 months

4. MRI or X-ray of the ankle within 60 days prior to the study procedure

5. Willing to comply with the prescribed post-operative rehabilitation program

6. Willing to be available for each protocol-required follow-up examination

7. 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

8. Ability to read, understand, and complete subject-reported outcomes in English

Exclusion criteria

1. Achilles tendon rupture
2. Previous Achilles tendon surgery on the index ankle
3. Genetic collagen disease
4. History of auto-immune or immunodeficiency disorders
5. History of chronic inflammatory disorders
6. Oral steroid use in last 2 months or injectable steroid use in last 4 weeks
7. History of heavy smoking (> 1 pack per day) within last 6 months
8. Hypersensitivity to bovine-derived materials
9. Hypersensitivity to Polylactic Acid (PLA) and Polyetheretherketone (PEEK) materials
10. Metal implants, fillings, shrapnel, and/or screws
11. Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study
12. Currently involved in any injury litigation or worker's compensation claims relating to the index ankle
13. Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study
14. History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation
15. History of cognitive or mental health status that interferes with study participation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Treatment

Experimental group

Description:

Treatment with Rotation Medical Bioinductive Implant

Treatment:

Device: Rotation Medical Bioinductive Implant