Clinical trial NCT02811003: Achilles Tendon Repair With Bioinductive Implant
Official title: Evaluation of the Rotation Medical Bioinductive Implant for Insertional Achilles Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendinopathy
Keywords: Insertional Achilles
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-23
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: New Tissue Thickness
timeFrame: 3, 12, and 24 months
measure: MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue)
timeFrame: 3, 12, and 24 months
measure: Tear Rate
timeFrame: following surgery to end of treatment at 24 months
Secondary outcomes:
measure: Device Implant Time
timeFrame: Intraoperatively, up to 9 minutes
measure: Number of Participants With Procedure Technical Success
timeFrame: Intraoperatively, up to 9 minutes
measure: CAM Boot Time
timeFrame: 1 week following surgery to 12 months
measure: Rehabilitation Visits
timeFrame: 4 weeks following surgery to end of treatment at 24 months
measure: Time to Recovery
timeFrame: following surgery to end of treatment at 24 months
measure: Participant Satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
Study officials:
affiliation: MedStar Union Memorial Hospital
name: Gregory P Guyton, MD
role: PRINCIPAL_INVESTIGATOR
References: