Full Thickness Rotator Cuff Tear
Conditions
Keywords
Mesenchymal stem cells
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.
Interventions
BIOLOGICALMesenchymal stem cell augmentation in rotator cuff repair
Patients undergoing mesenchymal stem cell augmentation will receive a total injection of 6 milliliters (mL). Of this, 3 mL will be injected in the tendon at the junction between bone and tendon, while 3 mL will be injected in the bone at the site of the surgical footprint.
All patients will undergo full thickness rotator cuff repair using a double row, transosseous-equivalent (TOE) repair with anchor/suture technique. Acromioplasty will be performed in all patients. Alternate procedures such as biceps tenotomy/tenodesis and distal clavicle excision will be performed at the discretion of the surgeon and recorded.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) Score | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Mesenchymal stem cell augmentation in rotator cuff repair: Patients undergoing mesenchymal stem cell augmentation will receive a total injection of 6 milliliters (mL). Of this, 3 mL will be injected in the tendon at the junction between bone and tendon, while 3 mL will be injected in the bone at the site of the surgical footprint.
Standard arthroscopic rotator cuff repair: All patients will undergo full thickness rotator cuff repair using a double row, transosseous-equivalent (TOE) repair with anchor/suture technique. Acromioplasty will be performed in all patients. Alternate procedures such as biceps tenotomy/tenodesis and distal clavicle excision will be performed at the discretion of the surgeon and recorded.
All patients underwent a shoulder exam pre-operatively as well as at 3 months, 6 months, 1 year and 2 years post-operatively. All patients completed the Standardized Shoulder Test (SST), ASES, Constant, SANE, and VR/SF-12 questionnaires preoperatively as well as 3 months, 6 months, 12 months, 18 months and 24 months postoperatively. | 28 |
| 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.
Standard arthroscopic rotator cuff repair: All patients will undergo full thickness rotator cuff repair using a double row, transosseous-equivalent (TOE) repair with anchor/suture technique. Acromioplasty will be performed in all patients. Alternate procedures such as biceps tenotomy/tenodesis and distal clavicle excision will be performed at the discretion of the surgeon and recorded.
All patients underwent a shoulder exam pre-operatively as well as at 3 months, 6 months, 1 year and 2 years post-operatively. All patients completed the Standardized Shoulder Test (SST), ASES, Constant, SANE, and VR/SF-12 questionnaires preoperatively as well as 3 months, 6 months, 12 months, 18 months and 24 months postoperatively. | 34 |
| Total | 62 |
Baseline characteristics
| Characteristic | Rotator Cuff Repair Without Stem Cells | Total | Rotator Cuff Repair With Stem Cells |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 22 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 40 Participants | 20 Participants |
| Age, Continuous | 47 years | 48 years | 49 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 45 Participants | 20 Participants |
| Region of Enrollment United States | 34 Participants | 62 Participants | 28 Participants |
| Sex: Female, Male Female | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Male | 14 Participants | 22 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 34 |
| other Total, other adverse events | 0 / 28 | 0 / 34 |
| serious Total, serious adverse events | 0 / 28 | 0 / 34 |
Outcome results
Primary
American Shoulder and Elbow Surgeons (ASES) Score
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
Time frame: One year
Population: This study analyzed the efficacy of using autologous Bone Marrow Aspirate Concentrate (BMAC) compared with a control group in the recovery from rotator cuff surgery of the shoulder. The primary analysis focused on the American Shoulder and Elbow Surgeons (ASES) Score at 12 months post-surgery.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rotator Cuff Repair With Stem Cells | American Shoulder and Elbow Surgeons (ASES) Score | 87 score on a scale |
| Rotator Cuff Repair Without Stem Cells | American Shoulder and Elbow Surgeons (ASES) Score | 89 score on a scale |