Demineralized Bone Matrix Rotator Cuff Study

NCT04686396 | Unknown FDA Device

• 1 other identifier: US-1300
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rotator Cuff Injuries

Outcome Measures

Primary Outcomes (1)

• MRI

  Rate of healing of the rotator cuff repair

  24 weeks

Secondary Outcomes (4)

• American Shoulder and Elbow Surgeons Shoulder Score (ASES score)

  pretreatment, 24 weeks, 1 year, 2 year and 5 year

• Veterans RAND Health (VR-12)

  pretreatment, 24 weeks, 1 year, 2 year and 5 year

• Single Assessment Numerical Evaluation (SANE)

  pretreatment, 24 weeks, 1 year, 2 year and 5 year

• Visual Analogue Scale (VAS)

  pretreatment, 24 weeks, 1 year, 2 year and 5 year

Study Arms (2)

Interpositional Group

EXPERIMENTAL

Demineralized bone matrix

Device: Demineralized bone matrix

Control

NO INTERVENTION

Without demineralized bone matrix

Interventions

Demineralized bone matrix DEVICE

Demineralized bone matrix

Interpositional Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Arthrex, Inc.: lead

Study Sites (1)

Southern Oregon Orthopedics

Medford, Oregon, 97504, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization shall be performed during surgery after intra-operative inclusion/exclusion eligibility has been met.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 28, 2020
• Study Start: September 1, 2019
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 2, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)