Demineralized Bone Matrix Rotator Cuff Study

• Sponsor: Arthrex, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04686396
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Injuries	Device: Demineralized bone matrix	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients will be randomized to have either the addition of demineralized bone matrix to their procedure (Interpositional Group), or standard Rotator Cuff repair without demineralized bone matrix administered (Control group).Patients will be randomized to have either the addition of demineralized bone matrix to their procedure (Interpositional Group), or standard Rotator Cuff repair without demineralized bone matrix administered (Control group).
• Masking: Single (Participant)
• Masking Description: Randomization shall be performed during surgery after intra-operative inclusion/exclusion eligibility has been met.
• Primary Purpose: Basic Science
• Official Title: Demineralized Bone Matrix Rotator Cuff Study
• Actual Study Start Date: Sep 1, 2019
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interpositional Group Demineralized bone matrix	Device: Demineralized bone matrix; Demineralized bone matrix
No Intervention: Control Without demineralized bone matrix

Outcome Measures

Primary Outcome Measures

1. MRI [24 weeks]

   Rate of healing of the rotator cuff repair

Secondary Outcome Measures

1. 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

2. 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)

3. 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)

4. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern Oregon Orthopedics	Medford	Oregon	United States	97504

Sponsors and Collaborators

• Arthrex, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arthrex, Inc.
• ClinicalTrials.gov Identifier: NCT04686396
• Other Study ID Numbers: US-1300
• First Posted: Dec 28, 2020
• Last Update Posted: Aug 2, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Rotator Cuff Injuries

Study Results

No Results Posted as of Aug 2, 2021