Demineralized Bone Matrix Rotator Cuff Study

Rotator Cuff Injuries Clinical Trial

Official title:

Demineralized Bone Matrix Rotator Cuff Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04686396
• Other study ID #: US-1300
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: September 2024

Study information

• Verified date: December 2020
• Source: Arthrex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries

Intervention

Device:
• Demineralized bone matrix
Demineralized bone matrix

Locations

Country	Name	City	State
United States	Southern Oregon Orthopedics	Medford	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Arthrex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI	Rate of healing of the rotator cuff repair	24 weeks
Secondary	American Shoulder and Elbow Surgeons Shoulder Score (ASES score)	Changes in patient self evaluation and physician assessment score	pretreatment, 24 weeks, 1 year, 2 year and 5 year
Secondary	Veterans RAND Health (VR-12)	Changes in patient reported general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring score up)	pretreatment, 24 weeks, 1 year, 2 year and 5 year
Secondary	Single Assessment Numerical Evaluation (SANE)	Changes in patient reported affected shoulder survey base on percentage (0 - 100%, 100% being normal)	pretreatment, 24 weeks, 1 year, 2 year and 5 year
Secondary	Visual Analogue Scale (VAS)	Changes in patient reported pain survey. 0 - 10 point scale (0 no pain, 10 worst possible pain)	pretreatment, 24 weeks, 1 year, 2 year and 5 year