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Patients undergoing rotator cuff repair surgery will experience improved tendon healing with the use of demineralized bone matrix augmentation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interpositional Group | Experimental | Demineralized bone matrix |
|
| Control | No Intervention | Without demineralized bone matrix |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Demineralized bone matrix | Device | Demineralized bone matrix |
|
| Measure | Description | Time Frame |
|---|---|---|
| MRI | Rate of healing of the rotator cuff repair | 24 weeks |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Oregon Orthopedics | Medford | Oregon | 97504 | United States |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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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).
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Randomization shall be performed during surgery after intra-operative inclusion/exclusion eligibility has been met.
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 |