Clinical trial NCT04686396: Demineralized Bone Matrix Rotator Cuff Study
Official title: Demineralized Bone Matrix Rotator Cuff Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Injuries
Lead sponsor: Arthrex, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-28
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: MRI
timeFrame: 24 weeks
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons Shoulder Score (ASES score)
timeFrame: pretreatment, 24 weeks, 1 year, 2 year and 5 year
measure: Veterans RAND Health (VR-12)
timeFrame: pretreatment, 24 weeks, 1 year, 2 year and 5 year
measure: Single Assessment Numerical Evaluation (SANE)
timeFrame: pretreatment, 24 weeks, 1 year, 2 year and 5 year
measure: Visual Analogue Scale (VAS)
timeFrame: pretreatment, 24 weeks, 1 year, 2 year and 5 year
Other outcomes:
Locations:
city: Medford
country: United States
facility: Southern Oregon Orthopedics
state: Oregon
Study officials:
References: