Demineralized Bone Matrix Rotator Cuff Study

Not Applicable

Active, not recruiting

• Conditions: Rotator Cuff Injuries
• Interventions: Device: Demineralized bone matrix

• Registration Number: NCT04686396
• Lead Sponsor: Arthrex, Inc.

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.

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-28
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-02
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interpositional Group	Demineralized bone matrix	Demineralized bone matrix

Primary Outcome Measures

Name	Time	Method
MRI	24 weeks	Rate of healing of the rotator cuff repair

Secondary Outcome Measures

Name	Time	Method
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
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)
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)
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)

Trial Locations

Locations (1)

Southern Oregon Orthopedics; 🇺🇸 Medford, Oregon, United States