Achilles Tendon Repair With Bioinductive Implant

Tendinopathy Clinical Trial

Official title:

Evaluation of the Rotation Medical Bioinductive Implant for Insertional Achilles Tendinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811003
• Other study ID #: 3672-01
• Status: Completed
• Phase: N/A
• Start date: June 3, 2016
• Est. completion date: September 17, 2019

Study information

• Verified date: March 2019
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 17, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tendinopathy

Intervention

Device:
• Rotation Medical Bioinductive Implant
Placement of bioinductive implant over repair of insertional Achilles tendinopathy

Locations

Country	Name	City	State
United States	MedStar Union Memorial Hospital	Baltimore	Maryland
United States	Allegheny Health Network	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	CAM Boot Time	Cumulative number of days spent in a controlled ankle motion walking boot (CAM boot).	1 week following surgery to 12 months
Secondary	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
Secondary	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
Secondary	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