Demineralized Bone Matrix Rotator Cuff Study

Arthrex

Status: Active, not recruiting

Conditions: Rotator Cuff Injuries

Treatments: Device: Demineralized bone matrix

Study type: Interventional

Funder types: Industry

Identifiers

NCT04686396

US-1300

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Interpositional Group

Experimental group

Description:

Demineralized bone matrix

Treatment:

Device: Demineralized bone matrix

Control

No Intervention group

Description:

Without demineralized bone matrix