NCT04686396

Demineralized Bone Matrix Rotator Cuff Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Arthrex, Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rotator Cuff Injuries

Interventions

Type	Name	Description
DEVICE	Demineralized bone matrix	Demineralized bone matrix

Timeline

• Start date: 2019-09-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2020-12-28
• Last updated: 2021-08-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study