Back to resultsDemineralized Bone Matrix Rotator Cuff Study
Primary Purpose
Rotator Cuff Injuries
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Demineralized bone matrix
Sponsored by
About this trial
This is an interventional basic science trial for Rotator Cuff Injuries
Eligibility Criteria
Inclusion Criteria:
- The Subject is between the ages of 40 and 75 years.
- Subject is planning to undergo arthroscopic surgery for full thickness rotator cuff tears (RCT) of supraspinatus and infraspinatus muscles, who are candidates for demineralized bone matrix with BMC.
- Two tendon tear or tear size equal to or greater than 3cm
- Amenable to double-row repair
- Primary rotator cuff tears with or without superior labral tear and/or biceps tear)
Exclusion Criteria:
- The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.
- The Subject objects to use of allograft
- Irreparable Rotator Cuff Tear
- Complete full thickness subscapularis tears of > than the superior 1/3 of the tendon (Lafosse grade 3 and above)
- < 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
- Recurrent shoulder instability
- Intra-articular injections (steroids) within 1 month of surgery
- RCR revisions
- Subject MRI taken more than 12 months prior to surgery
- Pregnant or planning to become pregnant during the study period
- Workman's compensation case
Sites / Locations
- Southern Oregon Orthopedics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interpositional Group
Control
Arm Description
Demineralized bone matrix
Without demineralized bone matrix
Outcomes
Primary Outcome Measures
MRI
Rate of healing of the rotator cuff repair
Secondary Outcome Measures
American Shoulder and Elbow Surgeons Shoulder Score (ASES score)
Changes in patient self evaluation and physician assessment score
Veterans RAND Health (VR-12)
Changes in patient reported general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring score up)
Single Assessment Numerical Evaluation (SANE)
Changes in patient reported affected shoulder survey base on percentage (0 - 100%, 100% being normal)
Visual Analogue Scale (VAS)
Changes in patient reported pain survey. 0 - 10 point scale (0 no pain, 10 worst possible pain)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04686396
Brief Title
Demineralized Bone Matrix Rotator Cuff Study
Official Title
Demineralized Bone Matrix Rotator Cuff Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arthrex, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients undergoing rotator cuff repair surgery will experience improved tendon healing with the use of demineralized bone matrix augmentation.
Detailed Description
This is a prospective randomized study comparing the outcomes of patient undergoing rotator cuff repair with either an interpositional procedure administering demineralized bone matrix (DBM), or a control group without demineralized bone matrix. Patient outcomes will be collected and compared between the two cohorts up to a five (5) year post-operative period and will include a range of subjective and functional outcomes, along with radiographic imaging.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to have either the addition of demineralized bone matrix to their procedure (Interpositional Group), or standard Rotator Cuff repair without demineralized bone matrix administered (Control group).
Masking
Participant
Masking Description
Randomization shall be performed during surgery after intra-operative inclusion/exclusion eligibility has been met.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interpositional Group
Arm Type
Experimental
Arm Description
Demineralized bone matrix
Arm Title
Control
Arm Type
No Intervention
Arm Description
Without demineralized bone matrix
Intervention Type
Device
Intervention Name(s)
Demineralized bone matrix
Intervention Description
Demineralized bone matrix
Primary Outcome Measure Information:
Title
MRI
Description
Rate of healing of the rotator cuff repair
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons Shoulder Score (ASES score)
Description
Changes in patient self evaluation and physician assessment score
Time Frame
pretreatment, 24 weeks, 1 year, 2 year and 5 year
Title
Veterans RAND Health (VR-12)
Description
Changes in patient reported general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring score up)
Time Frame
pretreatment, 24 weeks, 1 year, 2 year and 5 year
Title
Single Assessment Numerical Evaluation (SANE)
Description
Changes in patient reported affected shoulder survey base on percentage (0 - 100%, 100% being normal)
Time Frame
pretreatment, 24 weeks, 1 year, 2 year and 5 year
Title
Visual Analogue Scale (VAS)
Description
Changes in patient reported pain survey. 0 - 10 point scale (0 no pain, 10 worst possible pain)
Time Frame
pretreatment, 24 weeks, 1 year, 2 year and 5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The Subject is between the ages of 40 and 75 years.
Subject is planning to undergo arthroscopic surgery for full thickness rotator cuff tears (RCT) of supraspinatus and infraspinatus muscles, who are candidates for demineralized bone matrix with BMC.
Two tendon tear or tear size equal to or greater than 3cm
Amenable to double-row repair
Primary rotator cuff tears with or without superior labral tear and/or biceps tear)
Exclusion Criteria:
The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.
The Subject objects to use of allograft
Irreparable Rotator Cuff Tear
Complete full thickness subscapularis tears of > than the superior 1/3 of the tendon (Lafosse grade 3 and above)
< 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
Recurrent shoulder instability
Intra-articular injections (steroids) within 1 month of surgery
RCR revisions
Subject MRI taken more than 12 months prior to surgery
Pregnant or planning to become pregnant during the study period
Workman's compensation case
Facility Information:
Facility Name
Southern Oregon Orthopedics
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Demineralized Bone Matrix Rotator Cuff Study
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