Achilles Tendon Repair With Bioinductive Implant

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Rotation Medical Bioinductive Implant for Insertional Achilles Tendinopathy

Conditions
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Tendinopathy

Intervention / Treatment
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* Device: Rotation Medical Bioinductive Implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment with Rotation Medical Bioinductive Implant | Device: Rotation Medical Bioinductive Implant<br>* Placement of bioinductive implant over repair of insertional Achilles tendinopathy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New Tissue Thickness | Measurement of new tissue thickness in millimeters will be made from sagittal magnetic resonance imaging (MRI) at the level of the bone anchor. These measurements were made distal to the attachment of the Achilles tendon, which do not include the thickness of the repaired tendon; therefore, these thicknesses represent the thickness of the newly induced tissue only. | 3, 12, and 24 months | 
| MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue) | Combined measurement of tendon and new tissue thickness in millimeters will be made from sagittal magnetic resonance imaging (MRI) at the insertion (approximately 5-10mm proximal to the bone anchor). | 3, 12, and 24 months | 
| Tear Rate | Tear rate in the deep portion of the repair at the calcaneus following Achilles surgery will be assessed at each follow-up visit using magnetic resonance imaging (MRI). | following surgery to end of treatment at 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Implant Time | Time in minutes from introduction of the bioinductive implant into the surgical field to completion of the last staple | Intraoperatively, up to 9 minutes | 
| Number of Participants With Procedure Technical Success | The number of participants where the device was successfully delivered and affixed to target tendon location (i.e., study device was successfully implanted). | Intraoperatively, up to 9 minutes | 
| CAM Boot Time | Cumulative number of days spent in a controlled ankle motion walking boot (CAM boot). | 1 week following surgery to 12 months | 
| Rehabilitation Visits | Rehabilitation measured by the cumulative number of completed rehabilitation or physical therapy (PT) visits to treat index Achilles. | 4 weeks following surgery to end of treatment at 24 months | 
| Time to Recovery | Recovery will be measured by days to return to normal daily activity (i.e. full, unrestricted activity). | following surgery to end of treatment at 24 months | 
| Participant Satisfaction | Participant Satisfaction will determined based on the response to the statement I am satisfied with the results of my surgery. The response will be assessed with a 5-point Likert scale, which has 1 - very dissatisfied, 2 - dissatisfied, 3 - neither satisfied nor dissatisfied, 4 - satisfied, 5 - very satisfied | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insertional Achilles