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Achilles Tendon Repair With Bioinductive Implant

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ClinicalTrials.gov Identifier: NCT02811003
Recruitment Status : Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

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.

Condition or disease Intervention/treatment Phase
Tendinopathy Device: Rotation Medical Bioinductive Implant Not Applicable

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  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Rotation Medical Bioinductive Implant for Insertional Achilles Tendinopathy
Study Start Date : June 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

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




Primary Outcome Measures :
  1. Thickness of new tissue induction [ Time Frame: 12 months ]
    Measurement of tissue thickness in millimeters will be made from sagittal MRI images.


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 24 months ]
    Adverse events

  2. Recovery [ Time Frame: 12 months ]
    Recovery will be measured by days to return to work or normal activity.

  3. Satisfaction [ Time Frame: 24 months ]
    Satisfaction will be assessed with a 5-point Likert scale.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811003


Locations
United States, Maryland
MedStar Union Memorial Hospital
Baltimore, Maryland, United States, 21218
United States, Pennsylvania
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
Principal Investigator: Gregory P Guyton, MD MedStar Union Memorial Hospital

Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT02811003     History of Changes
Other Study ID Numbers: 3672-01
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Smith & Nephew, Inc.:
Insertional Achilles

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries