Platelet rich plasma and rotator cuff tendons

Completed

• Conditions: Rotator cuff impingement and tears; Injury, Occupational Diseases, Poisoning; Shoulder injuries

• Registration Number: ISRCTN10464365
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-29
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified