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Platelet rich plasma and rotator cuff tendons

A randomised controlled trial to assess the effectiveness of treating subacromial impingement and partial thickness rotator cuff tears wtih the administration of Platelet Rich Plasma during arthroscopic decompression surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10464365
Enrollment
34
Registered
2011-03-29
Start date
2010-10-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator cuff impingement and tears Injury, Occupational Diseases, Poisoning Shoulder injuries

Interventions

Subacromial decompression: Subacromial decompression surgery is performed under general anaesthetic. The procedure involves insertion of the arthroscope into the glenohumeral joint where the joint sur

Sponsors

University of Oxford (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with shoulder impingement syndrome or a partial thickness rotator cuff tear 2. Diagnosis confirmed using ultrasound scan by a trained member of the research team 3. Failed conservative treatment 4. Listed for arthroscopic subacromial decompression 5. Male or female, aged 35 - 75 years old

Exclusion criteria

Exclusion criteria: 1. Full thickness rotator cuff tears 2. Participants with a history of significant trauma (fracture, dislocation/instability, etc.), surgery, osteoarthritis or other significant pathology of the affected shoulder not related to the rotator cuff 3. Patient is unable to consent for themselves 4. No conservative treatment 5. Previous surgery on affected surgery 6. Contraindications to PRP (listed below): 6.1. History of diabetes mellitus 6.2. Platelet abnormality or platelets count less than 100 x 10^9/l 6.3. Haematological disorder 6.4. Serum haemoglobin less than 11 g/dl 6.5. Use of systemic cortisone 6.6. Use of any anticoagulant 6.7. Evidence of gangrene/ulcers or peripheral vascular disease 6.8. History of hepatic or renal impairment or dialysis 6.9. Patient is known to have a psychological, developmental, physical, emotional or social disorder that may interfere with compliance with study requirements 6.10. History of alcohol or drug abuse 6.11. Patient has a religious or cultural conflict with the use of platelet gel treatment or blood products 6.12. Patient has inadequate venous access for blood draw 6.13. Patient is currently receiving or has received radiation or chemotherapy within the last 3 months prior to the study 6.14. Female participants who are pregnant, lactating or planning pregnancy during the course of the study 6.15. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study

Design outcomes

Primary

MeasureTime frame
Oxford Shoulder Score at 6 months post-treatment

Secondary

MeasureTime frame
1. Functional shoulder assessments 2. EQ5D 3. Oxford Satisfaction Index Measured at baseline and 3 weeks, 3 months, 6 months and 12 months post-treatment.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026