search
Back to results

Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears

Primary Purpose

Full Thickness Rotator Cuff Tear

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Augment Rotator Cuff
Standard Suture Repair
Sponsored by
BioMimetic Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Full Thickness Rotator Cuff Tear focused on measuring tendon, shoulder, rotator cuff, Glenohumeral

Eligibility Criteria

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

Inclusion Criteria:

  • The subject has a repairable rotator cuff tear with an estimated full thickness size of ≥ 2 cm to < 5 cm confirmed with diagnostic MRI in AP or ML dimension
  • The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits
  • The subject is at least twenty one (21) years of age and considered to be skeletally mature.

Exclusion Criteria:

  • The subject has undergone previous rotator cuff repair surgery to the affected shoulder
  • The subject has a partial thickness rotator cuff tear
  • The subject requires a concomitant subscapularis repair
  • The subject requires a concomitant labral repair
  • The subject has an irreparable rotator cuff tear
  • The subject has an allergy to yeast-derived products or a known bovine collagen allergy
  • The subject has implanted metallic devices (cardiac pacemakers, insulin pumps, and nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI scan of the shoulder
  • The subject has tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed Augment Rotator Cuff implantation site
  • The subject's condition represents a worker's compensation case
  • The subject is currently involved in a health-related litigation procedure
  • The subject is pregnant or able to become pregnant but not practicing a medically-accepted form of birth control, and/or intending to become pregnant during this study period

Sites / Locations

  • Fowler Kennedy Sports Medicine Clinic
  • Hand and Upper Limb Clinic - St. Joseph's Health Care London
  • Ottawa Hospital
  • St. Michaels Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Standard Suture Repair + Augment Rotator Cuff

Standard Suture Repair

Outcomes

Primary Outcome Measures

Magnetic Resonance Imaging (MRI)
The scans were evaluated for degree of re-tears (no re-tears, partial or complete re-tear) by an independent radiologist to assess device integrity and surgical treatment of the rotator cuff tear.
Disabilities of the Arm, Shoulder and Hand (DASH)
a self-report questionnaire evaluates the subjects' symptoms and ability to perform activities of daily living, athletic activities and homemaking/work activities. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100
Western Ontario Rotator Cuff Index (WORC)
a self-report questionnaire specifically designed to evaluate disability in persons with pathology of the rotator cuff. Each question uses a visual analogue scale (VAS) - which is a straight line, representing a 100-point scale, ranging from 0-100, with a higher score representing lower quality of life.
Constant-Murley Shoulder Outcome Score (CSS)
to assess the shoulder and determine at minimum the range of motion (ROM), external rotation and internal rotation, and power score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2010
Last Updated
February 15, 2019
Sponsor
BioMimetic Therapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT01256242
Brief Title
Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears
Official Title
A Single Blinded, Multi-center, Randomized, Controlled, Pilot Study to Evaluate the Safety and Performance of Augment™ Rotator Cuff for Primary Surgical Treatment of Full Thickness Rotator Cuff Tears
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 24, 2010 (Actual)
Primary Completion Date
November 16, 2012 (Actual)
Study Completion Date
November 16, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioMimetic Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary surgical treatment for full thickness rotator cuff tears. The hypothesis is that Augment Rotator Cuff will be easy to deliver as an inter-positional graft placed between the rotator cuff tendon and the humeral head providing further enhanced tendon to bone healing without adding any additional safety risk to the patient. Study Rationale: To evaluate the safety and performance Augment™ Rotator Cuff in surgical intervention of a torn rotator cuff and to obtain preliminary data to support the rationale for a subsequent pivotal clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full Thickness Rotator Cuff Tear
Keywords
tendon, shoulder, rotator cuff, Glenohumeral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Standard Suture Repair + Augment Rotator Cuff
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Standard Suture Repair
Intervention Type
Device
Intervention Name(s)
Augment Rotator Cuff
Intervention Description
rhPDGF-BB and bovine collagen matrix
Intervention Type
Procedure
Intervention Name(s)
Standard Suture Repair
Intervention Description
standard suture repair
Primary Outcome Measure Information:
Title
Magnetic Resonance Imaging (MRI)
Description
The scans were evaluated for degree of re-tears (no re-tears, partial or complete re-tear) by an independent radiologist to assess device integrity and surgical treatment of the rotator cuff tear.
Time Frame
24 weeks
Title
Disabilities of the Arm, Shoulder and Hand (DASH)
Description
a self-report questionnaire evaluates the subjects' symptoms and ability to perform activities of daily living, athletic activities and homemaking/work activities. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100
Time Frame
24 weeks
Title
Western Ontario Rotator Cuff Index (WORC)
Description
a self-report questionnaire specifically designed to evaluate disability in persons with pathology of the rotator cuff. Each question uses a visual analogue scale (VAS) - which is a straight line, representing a 100-point scale, ranging from 0-100, with a higher score representing lower quality of life.
Time Frame
24 weeks
Title
Constant-Murley Shoulder Outcome Score (CSS)
Description
to assess the shoulder and determine at minimum the range of motion (ROM), external rotation and internal rotation, and power score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject has a repairable rotator cuff tear with an estimated full thickness size of ≥ 2 cm to < 5 cm confirmed with diagnostic MRI in AP or ML dimension The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits The subject is at least twenty one (21) years of age and considered to be skeletally mature. Exclusion Criteria: The subject has undergone previous rotator cuff repair surgery to the affected shoulder The subject has a partial thickness rotator cuff tear The subject requires a concomitant subscapularis repair The subject requires a concomitant labral repair The subject has an irreparable rotator cuff tear The subject has an allergy to yeast-derived products or a known bovine collagen allergy The subject has implanted metallic devices (cardiac pacemakers, insulin pumps, and nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI scan of the shoulder The subject has tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed Augment Rotator Cuff implantation site The subject's condition represents a worker's compensation case The subject is currently involved in a health-related litigation procedure The subject is pregnant or able to become pregnant but not practicing a medically-accepted form of birth control, and/or intending to become pregnant during this study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Litchfield, MD, FRCSC
Organizational Affiliation
Fowler Kennedy Sport Medicine Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fowler Kennedy Sports Medicine Clinic
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
Facility Name
Hand and Upper Limb Clinic - St. Joseph's Health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
St. Michaels Hospital
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.aaos.org
Description
American Academy of Orthopaedic Surgeons

Learn more about this trial

Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears

We'll reach out to this number within 24 hrs