N/A
Completed N=20
Achilles Tendon Repair With Bioinductive Implant
Source: ClinicalTrials.gov NCT02811003 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Nov 2022
Primary outcomePrimary: New Tissue Thickness — 5.40; 5.70; 5.50 millimeters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY New Tissue Thickness |
5.40; 5.70; 5.50 | — |
| PRIMARY MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue) |
8.20; 16.80; 18.40 | — |
| PRIMARY Tear Rate |
17; 3 | — |
| SECONDARY Device Implant Time |
5.40 | — |
| SECONDARY Number of Participants With Procedure Technical Success |
20; 0 | — |
| SECONDARY CAM Boot Time |
76.30 | — |
| SECONDARY Rehabilitation Visits |
17.90 | — |
| SECONDARY Time to Recovery |
167.80 | — |
| SECONDARY Participant Satisfaction |
1; 1; 1; 7; 7 | — |
Eligibility Criteria
Inclusion Criteria
- At least 21 years of age
- 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
- 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
- Hypersensitivity to Polylactic Acid (PLA) and Polyetheretherketone (PEEK) materials
- Metal implants, fillings, shrapnel, and/or screws
- Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study
- Currently involved in any injury litigation or worker's compensation claims relating to the index ankle
- Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study
- History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation
- History of cognitive or mental health status that interferes with study participation
Data sourced from ClinicalTrials.gov (NCT02811003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.