Large (2-5 cm in width) chronic rotator cuff tear Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Patients will be randomly allocated to a control group, a bone marrow aspirate concentrate (BMAC)+platelet-rich plasma (PRP) group and a PRP-only group. Randomization will be performed using a predete
Sponsors
Hallym University
Eligibility
Sex/Gender
All
Age
18 Years to 72 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged at least 18 years 2. A large (2-5 cm in width) chronic rotator cuff tear confirmed by preoperative magnetic resonance imaging (MRI) 3. No history of shoulder surgery within the past 3 months 4. No abnormal findings on simple radiography, repair via arthroscopy 5. No abnormalities in blood coagulation or routine laboratory examination 6. No history of steroid injection within the past 3 months 7. No history of malignancy
Exclusion criteria
Exclusion criteria: 1. Subscapularis tendon disruptions (> 1/2 width) 2. Revision surgery 3. Inflammatory or autoimmune diseases 4. Reoperation due to re-tear 5. Other body parts operated within 6 months before and after rotator cuff repair 6. Any other associated shoulder lesion 7. Other severe medical problems, such as malignancy, respiratory disease, and preexisting coagulopathy 8. Positive urine pregnancy test in fertile women 9. Recent steroid injection within the past 3 months 10. Patients who refused to provide consent 11. Those who had difficulty partaking in clinical trials by the responsible investigator 12. Patients with cuff retraction or atrophy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain will be measured using the VAS at baseline (pre-surgery), 3 months and 6 months post-surgery . 2. Shoulder function will be measured using the ASES Shoulder Score at baseline (pre-surgery), 3 months and 6 months post-surgery. 3. Pain and ability to carry out normal daily activities will be measured using the constant score at baseline (pre-surgery), 3 months and 6 months post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. MRI assessment of the supraspinatus, infraspinatous evaluates Muscle volume, Goutallier score of muscle atrophy and fatty infiltration at baseline (pre-surgery) and 6 months post-surgery. 2. Shoulder ultrasound examination evaluates rotator cuff tear size and lesion in millimeters at baseline (pre-surgery) and 3 weeks 3 months post-surgery | — |
Countries
Korea, South
Contacts
Public ContactKyu-Cheol Noh
Outcome results
None listed