Demineralized Bone Matrix Rotator Cuff Study

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 2024

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.

Interventions

  • Device: Demineralized bone matrix
    • Demineralized bone matrix

Arms, Groups and Cohorts

  • Experimental: Interpositional Group
    • Demineralized bone matrix
  • No Intervention: Control
    • Without demineralized bone matrix

Clinical Trial Outcome Measures

Primary Measures

  • MRI
    • Time Frame: 24 weeks
    • Rate of healing of the rotator cuff repair

Secondary Measures

  • American Shoulder and Elbow Surgeons Shoulder Score (ASES score)
    • Time Frame: pretreatment, 24 weeks, 1 year, 2 year and 5 year
    • Changes in patient self evaluation and physician assessment score
  • Veterans RAND Health (VR-12)
    • Time Frame: 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)
  • Single Assessment Numerical Evaluation (SANE)
    • Time Frame: 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)
  • Visual Analogue Scale (VAS)
    • Time Frame: 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Arthrex, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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