Demineralized Bone Matrix Rotator Cuff Study

Study Overview
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Brief Summary
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Patients undergoing rotator cuff repair surgery will experience improved tendon healing with the use of demineralized bone matrix augmentation.

Detailed Description
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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.

Official Title
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Demineralized Bone Matrix Rotator Cuff Study

Conditions
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Rotator Cuff Injuries

Intervention / Treatment
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* Device: Demineralized bone matrix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interpositional Group<br>Demineralized bone matrix | Device: Demineralized bone matrix<br>* Demineralized bone matrix<br>|
| No Intervention: Control<br>Without demineralized bone matrix | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI | Rate of healing of the rotator cuff repair | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeons Shoulder Score (ASES score) | Changes in patient self evaluation and physician assessment score | pretreatment, 24 weeks, 1 year, 2 year and 5 year | 
| 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) | pretreatment, 24 weeks, 1 year, 2 year and 5 year | 
| Single Assessment Numerical Evaluation (SANE) | Changes in patient reported affected shoulder survey base on percentage (0 - 100%, 100% being normal) | pretreatment, 24 weeks, 1 year, 2 year and 5 year | 
| Visual Analogue Scale (VAS) | Changes in patient reported pain survey. 0 - 10 point scale (0 no pain, 10 worst possible pain) | pretreatment, 24 weeks, 1 year, 2 year and 5 year |