Achilles Tendon Repair With Bioinductive Implant

Evaluation of the Rotation Medical Bioinductive Implant for Insertional Achilles Tendinopathy

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.

Study Overview

• Status: Completed
• Conditions: Tendinopathy
• Intervention / Treatment: Device: Rotation Medical Bioinductive Implant

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Treatment with Rotation Medical Bioinductive Implant	Device: Rotation Medical Bioinductive Implant; Placement of bioinductive implant over repair of insertional Achilles tendinopathy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Gregory P Guyton, MD, MedStar Union Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2016
• Primary Completion (Actual): September 17, 2019
• Study Completion (Actual): September 17, 2019

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (Estimate): June 23, 2016

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Insertional Achilles
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: 3672-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No