Demineralized Bone Matrix Rotator Cuff Study

Status unconfirmed · Not applicable

Conditions studied: Rotator Cuff Injuries

In brief

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

Key facts

Study ID

NCT04686396

Run by

Arthrex, Inc.

People needed

100

Starts

2019-09-01

Expected to finish

2024-09-01

Last updated by the study team

2021-08-02

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Southern Oregon Orthopedics — Medford, Oregon, United States

Full record on ClinicalTrials.gov

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