Rotator Cuff Injuries
Conditions
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.
Interventions
Demineralized bone matrix
Sponsors
Arthrex, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
Randomization shall be performed during surgery after intra-operative inclusion/exclusion eligibility has been met.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI | 24 weeks | Rate of healing of the rotator cuff repair |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons Shoulder Score (ASES score) | pretreatment, 24 weeks, 1 year, 2 year and 5 year | Changes in patient self evaluation and physician assessment score |
| Veterans RAND Health (VR-12) | pretreatment, 24 weeks, 1 year, 2 year and 5 year | 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) | pretreatment, 24 weeks, 1 year, 2 year and 5 year | Changes in patient reported affected shoulder survey base on percentage (0 - 100%, 100% being normal) |
| Visual Analogue Scale (VAS) | pretreatment, 24 weeks, 1 year, 2 year and 5 year | Changes in patient reported pain survey. 0 - 10 point scale (0 no pain, 10 worst possible pain) |
Countries
United States
Outcome results
None listed