Clinical outcomes of platelet-rich plasma and bone marrow aspirate concentrate on repair of rotator cuff tears

Not Applicable

Completed

• Conditions: arge (2-5 cm in width) chronic rotator cuff tear; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN69088783
• Lead Sponsor: Hallym University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-09-01
• Study Start: 2024-08-27
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 93

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Pain will be measured using the VAS at baseline (pre-surgery), 3 months and 6 months post-surgery .<br>2. Shoulder function will be measured using the ASES Shoulder Score at baseline (pre-surgery), 3 months and 6 months post-surgery.<br>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<br>

Secondary Outcome Measures

Name	Time	Method
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.<br>2. Shoulder ultrasound examination evaluates rotator cuff tear size and lesion in millimeters at baseline (pre-surgery) and 3 weeks 3 months post-surgery