Achilles Tendon Repair With Bioinductive Implant

Not Applicable

Completed

Brief 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment	Rotation Medical Bioinductive Implant	Treatment with Rotation Medical Bioinductive Implant

Primary Outcome Measures

Name	Time	Method
MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue)	3, 12, and 24 months	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).
New Tissue Thickness	3, 12, and 24 months	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.
Tear Rate	following surgery to end of treatment at 24 months	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).

Secondary Outcome Measures

Name	Time	Method
Participant Satisfaction	12 months	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
Device Implant Time	Intraoperatively, up to 9 minutes	Time in minutes from introduction of the bioinductive implant into the surgical field to completion of the last staple
CAM Boot Time	1 week following surgery to 12 months	Cumulative number of days spent in a controlled ankle motion walking boot (CAM boot).
Rehabilitation Visits	4 weeks following surgery to end of treatment at 24 months	Rehabilitation measured by the cumulative number of completed rehabilitation or physical therapy (PT) visits to treat index Achilles.
Time to Recovery	following surgery to end of treatment at 24 months	Recovery will be measured by days to return to normal daily activity (i.e. full, unrestricted activity).
Number of Participants With Procedure Technical Success	Intraoperatively, up to 9 minutes	The number of participants where the device was successfully delivered and affixed to target tendon location (i.e., study device was successfully implanted).

Locations (2): MedStar Union Memorial Hospital
🇺🇸
Baltimore, Maryland, United States
Allegheny Health Network
🇺🇸
Pittsburgh, Pennsylvania, United States