A Prospective Randomized Trial of Biologic Augmentation With Mesenchymal Stem Cells in Patients Undergoing Arthroscopic Rotator Cuff Repair
Overview
- Phase
- N/A
- Intervention
- Mesenchymal stem cell augmentation in rotator cuff repair
- Conditions
- Full Thickness Rotator Cuff Tear
- Sponsor
- Rush University Medical Center
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- American Shoulder and Elbow Surgeons (ASES) Score
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
The primary objective of this study is to compare the clinical outcomes of arthroscopic rotator cuff repair with and without augmentation of mesenchymal stem cells (MSCs). Mesenchymal stem cells promote tissue regeneration by differentiating into adult cell lines and by supplying growth factors to their implanted environment. They have been shown to be effective in improving both overall healing and tendon integrity in rotator cuff repair. This study will follow 100 patients in the United States and track their clinical outcomes for at least one year post-operatively.
Detailed Description
Rotator cuff repair is one of the most commonly performed arthroscopic procedures in the United States, but re-tear remains a common long-term complication. This can lead to pain, decreased shoulder function, and the need for corrective surgery. Mesenchymal stem cells have been shown to improve healing rates in arthroscopic rotator cuff repair, primarily due to their retained ability to differentiate into several different adult cell lines, such as tenocytes, chondrocytes, and osteoblasts. MSCs further enhance the healing process by releasing growth factors into the local environment to promote tissue regeneration. While MSC augmentation of arthroscopic rotator cuff repair has led to higher rates of healing and improved tendon integrity, there remains a paucity of data surrounding clinical improvement after the procedure. Outcomes such as post-operative strength, range of motion, and shoulder function have yet to be compared with standard rotator cuff repair. The incidence of post-operative persistent structural defects in the tendon after MSC augmentation must also be further elucidated.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is determined to have a full thickness rotator cuff tear (1-3 cm) or partial tear converted to a full-thickness tear-on the pre-operative MRI scan or found arthroscopically-and is scheduled to undergo surgical repair
- •Written informed consent is obtained
Exclusion Criteria
- •Revision surgery
- •Irreparable tear or partial repair
- •Any patient lacking decisional capability
- •Subscapularis involvement
Arms & Interventions
Rotator cuff repair with stem cells
Using clinically accepted methods, subjects will undergo bone marrow aspiration (from hip, proximal humerus or tibia) through a small incision prior to arthroscopy in the group undergoing MSC augmentation. They will then undergo arthroscopic full thickness rotator cuff repair using a double row, TOE anchor/suture technique with mesenchymal stem cell augmentation.
Intervention: Mesenchymal stem cell augmentation in rotator cuff repair
Rotator cuff repair with stem cells
Using clinically accepted methods, subjects will undergo bone marrow aspiration (from hip, proximal humerus or tibia) through a small incision prior to arthroscopy in the group undergoing MSC augmentation. They will then undergo arthroscopic full thickness rotator cuff repair using a double row, TOE anchor/suture technique with mesenchymal stem cell augmentation.
Intervention: Standard arthroscopic rotator cuff repair
Rotator cuff repair without stem cells
Subjects will undergo arthroscopic full thickness rotator cuff repair using a double row, TOE anchor/suture technique, without augmentation of mesenchymal stem cells. To maintain patient blinding, all patients will receive a small incision around the site of expected bone marrow aspiration (hip, proximal humerus, or tibia), regardless of whether or not they receive bone marrow.
Intervention: Standard arthroscopic rotator cuff repair
Outcomes
Primary Outcomes
American Shoulder and Elbow Surgeons (ASES) Score
Time Frame: One year
The American Shoulder and Elbow Surgeons (ASES) score is a patient-reported score that measures shoulder pain, activity level and stability. The score ranges from 0 to 100, with higher scores indicating better shoulder function. Excellent: 90-100 points Good: 70-89 points Fair: 40-49 points Poor: Less than 39 points