Rotator Cuff Injury, Rotator Cuff Tear
Conditions
Keywords
Bone marrow aspirate, Biologics
Brief summary
The primary objective is to determine whether adjunct treatment using bone marrow aspirate concentrate (BMAC) in conjunction with arthroscopic repair of rotator cuff tears reduces retear rates compared to a control population undergoing arthroscopic repair without BMAC administration. The secondary objectives are to (1) evaluate the survival and incorporation of BMAC labeled cells with MRI imaging using the Ferumoxytol infusion stem cell labeling technique, and (2) determine if administration of BMAC leads to better clinical outcomes as measured by ASES, UCLA and Constant scoring metrics.
Detailed description
Rotator cuff repair and regeneration has become a focal point for scientists and surgeons in search for a biological treatment to improve tendon healing, especially in situations of unfavorable biological conditions. Recent literature supports harvesting and centrifuging bone marrow aspirate to produce bone marrow aspirate concentration (BMAC) in hopes that mesenchymal stem cells in the bone marrow aspirate can promote tendon healing and regeneration. This is a single blinded randomized clinical trial using labeled BMAC cells in adults diagnosed with medium to large, single tears of the rotator cuff. This is a single site study where at least 45 cases among eligible patients will be identified and randomly assigned to a either a control (arthroscopic repair without BMAC) group or experimental (arthroscopic repair with BMAC) group. A power analysis will be performed after enrolling 20 patients to determine the total number of patients required to reach adequate power. A patient will receive an infusion of Ferumoxytol 1 day prior to the surgical procedure. An infusion nurse will be present at all times during the infusion to monitor vitals. On the day of the surgical procedure patients in the both groups will undergo arthroscopic rotator cuff repair using a double-row technique. Patients in the experimental group will also undergo harvesting of bone marrow aspirate from the anterior inferior iliac crest, which will be centrifuged to about 3-4cc of BMAC and placed beneath the tendon at the bone interface. MRIs will be completed on days 1 and 7 post-operatively to track retention of the labeled mesenchymal cells. Ultrasound imaging will be performed at 6 months post-surgery to evaluate tendon healing. Final MRIs will be obtained at 1 year and 2 years post surgery. Patient related outcomes will be collected at the pre-operative visit, 3 months, 6 months, 1 year and 2 years post surgery in the forms of ASES, UCLA and Constant scoring.
Interventions
PROCEDUREArthroscopic rotator cuff repair with bone marrow aspirate concentrate
Subjects will undergo shoulder arthroscopy for rotator cuff repair using a double row technique. Subjects will also be injected with bone marrow aspirate concentrate harvested from the pelvis and centrifuged prior to injection in the shoulder (produced using the Harvest/Terumo BCT system)
PROCEDUREArthroscopic rotator cuff repair
Subjects will undergo shoulder arthroscopy for rotator cuff repair using a double row technique.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients will not know if they received the surgical intervention that includes BMAC administration
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 50-75 patients with MRI confirmed rotator cuff tears sized 1.5-3cm including supraspinatus with or without an associated partial infraspinatus or subscapularis tear * Chronic tear \> 3 months * Failed a minimum of 6 weeks of physical therapy * Hamada stage 1 * Goutallier staging \< 3
Exclusion criteria
* Radiographs demonstrating mild to moderate arthritis * Diagnosis of Inflammatory (RA, JIA etc) or infectious arthritis * Hamada stage \> 2 * Cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months * Brachial plexus pathology * Currently pregnant or planning to become pregnant * Shoulder PRP injection within the last year * History of iron overload syndrome * Concurrent surgery for shoulder instability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tendon healing rates | 24 months | Percent of rotator cuff repairs that demonstrate full healing at 2 years post surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UCLA Score | Date of enrollment to 24 months post-operatively | UCLA score (0-35 points; higher score is better) at 24 months post surgery to measure functional outcome. |
| ASES Score | Date of enrollment to 24 months post-operatively | American Shoulder and Elbow Surgeons Shoulder Score (ASES) (0-100 points; higher score is better) at 24 months to measure functional outcome. |
| Constant Score | Date of enrollment to 24 months post-operatively | Constant score (0-100 points; higher score is better) at 24 months. |
| Retention of the mesenchymal stem cells | 7 days | Imaging of labeled mesenchymal stems cells in the shoulder to assess retention post injection |
Countries
United States
Outcome results
None listed