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Achilles Tendon Repair With Bioinductive Implant

Primary Purpose

Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rotation Medical Bioinductive Implant
Sponsored by
Smith & Nephew, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring Insertional Achilles

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MedStar Union Memorial Hospital
  • Allegheny Health Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Treatment with Rotation Medical Bioinductive Implant

Outcomes

Primary Outcome Measures

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.
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).
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).

Secondary Outcome Measures

Device Implant Time
Time in minutes from introduction of the bioinductive implant into the surgical field to completion of the last staple
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).
CAM Boot Time
Cumulative number of days spent in a controlled ankle motion walking boot (CAM boot).
Rehabilitation Visits
Rehabilitation measured by the cumulative number of completed rehabilitation or physical therapy (PT) visits to treat index Achilles.
Time to Recovery
Recovery will be measured by days to return to normal daily activity (i.e. full, unrestricted activity).
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

Full Information

First Posted
June 14, 2016
Last Updated
October 10, 2022
Sponsor
Smith & Nephew, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02811003
Brief Title
Achilles Tendon Repair With Bioinductive Implant
Official Title
Evaluation of the Rotation Medical Bioinductive Implant for Insertional Achilles Tendinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 3, 2016 (Actual)
Primary Completion Date
September 17, 2019 (Actual)
Study Completion Date
September 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
Insertional Achilles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment with Rotation Medical Bioinductive Implant
Intervention Type
Device
Intervention Name(s)
Rotation Medical Bioinductive Implant
Intervention Description
Placement of bioinductive implant over repair of insertional Achilles tendinopathy
Primary Outcome Measure Information:
Title
New Tissue Thickness
Description
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.
Time Frame
3, 12, and 24 months
Title
MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue)
Description
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).
Time Frame
3, 12, and 24 months
Title
Tear Rate
Description
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).
Time Frame
following surgery to end of treatment at 24 months
Secondary Outcome Measure Information:
Title
Device Implant Time
Description
Time in minutes from introduction of the bioinductive implant into the surgical field to completion of the last staple
Time Frame
Intraoperatively, up to 9 minutes
Title
Number of Participants With Procedure Technical Success
Description
The number of participants where the device was successfully delivered and affixed to target tendon location (i.e., study device was successfully implanted).
Time Frame
Intraoperatively, up to 9 minutes
Title
CAM Boot Time
Description
Cumulative number of days spent in a controlled ankle motion walking boot (CAM boot).
Time Frame
1 week following surgery to 12 months
Title
Rehabilitation Visits
Description
Rehabilitation measured by the cumulative number of completed rehabilitation or physical therapy (PT) visits to treat index Achilles.
Time Frame
4 weeks following surgery to end of treatment at 24 months
Title
Time to Recovery
Description
Recovery will be measured by days to return to normal daily activity (i.e. full, unrestricted activity).
Time Frame
following surgery to end of treatment at 24 months
Title
Participant Satisfaction
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory P Guyton, MD
Organizational Affiliation
MedStar Union Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Union Memorial Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Allegheny Health Network
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Achilles Tendon Repair With Bioinductive Implant

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