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Completed

NCT Number: NCT02811003

Achilles Tendon Repair With Bioinductive Implant

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.

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Key information

Conditions

Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Union Memorial Hospital, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Rotation Medical Bioinductive Implant

Device

Placement of bioinductive implant over repair of insertional Achilles tendinopathy

Primary outcomes

  1. New Tissue Thickness

    Time frame: 3, 12, and 24 months

    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.

  2. MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue)

    Time frame: 3, 12, and 24 months

    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. Tear Rate

    Time frame: following surgery to end of treatment at 24 months

    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).

Secondary outcomes

  1. Device Implant Time

    Time frame: Intraoperatively, up to 9 minutes

    Time in minutes from introduction of the bioinductive implant into the surgical field to completion of the last staple

  2. Number of Participants With Procedure Technical Success

    Time frame: Intraoperatively, up to 9 minutes

    The number of participants where the device was successfully delivered and affixed to target tendon location (i.e., study device was successfully implanted).

  3. CAM Boot Time

    Time frame: 1 week following surgery to 12 months

    Cumulative number of days spent in a controlled ankle motion walking boot (CAM boot).

  4. Rehabilitation Visits

    Time frame: 4 weeks following surgery to end of treatment at 24 months

    Rehabilitation measured by the cumulative number of completed rehabilitation or physical therapy (PT) visits to treat index Achilles.

  5. Time to Recovery

    Time frame: following surgery to end of treatment at 24 months

    Recovery will be measured by days to return to normal daily activity (i.e. full, unrestricted activity).

  6. Participant Satisfaction

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

Evaluation of the Rotation Medical Bioinductive Implant for Insertional Achilles Tendinopathy

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 23, 2016
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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