Achilles Tendon Repair With Bioinductive Implant

NCT02811003 | Completed Results

• 1 other identifier: 3672-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Tendinopathy

Keywords

Insertional Achilles

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Device Implant Time

  Intraoperatively, up to 9 minutes

• Number of Participants With Procedure Technical Success

  Intraoperatively, up to 9 minutes

• CAM Boot Time

  1 week following surgery to 12 months

• Rehabilitation Visits

  4 weeks following surgery to end of treatment at 24 months

• Time to Recovery

  following surgery to end of treatment at 24 months

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with Rotation Medical Bioinductive Implant

Device: Rotation Medical Bioinductive Implant

Interventions

Rotation Medical Bioinductive Implant DEVICE

Placement of bioinductive implant over repair of insertional Achilles tendinopathy

Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (2)

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Results Point of Contact

• Title: Samantha Andrews
• Organization: Smith+Nephew, Inc.

samantha.andrews@smith-nephew.com

978.971.8990

Study Officials

• Gregory P Guyton, MD

  MedStar Union Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 23, 2016
• Study Start: June 3, 2016
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: November 4, 2022
• Results First Posted: November 4, 2022

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)