Demineralized Bone Matrix Rotator Cuff Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Rotator Cuff Injuries
• Intervention / Treatment: Device: Demineralized bone matrix

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Medford, Oregon, United States, 97504
      • Southern Oregon Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI	Rate of healing of the rotator cuff repair	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Arthrex, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: December 23, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 30, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: US-1300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes