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. 2014 Apr 29;2014(4):CD010071. doi: 10.1002/14651858.CD010071.pub3

NCT01170312.

Trial name or title Arthroscopic surgery and platelet rich plasma In rotator cuff tear evaluation (ASPIRE): the use of platelet rich plasma following arthroscopic repair of rotator cuff tears, a pilot study
Methods Study design: randomised trial
 Random sequence generation: not reported
 Allocation concealment: not reported
 Masking: double blind (subject, investigator, outcome assessor)
Participants Location: not reported
 Target sample size (N): 25
 Inclusion criteria: men or women; 18‐70 years of age; primary, traumatic or degenerative rotator cuff tears measuring 3 cm or less; rotator cuff tears requiring arthroscopic repair within 18 months of initial diagnosis; provision of informed consent
 Exclusion criteria: rotator cuff tears secondary to a fracture; an associated dislocation at the time of randomisation; rotator cuff tears that have had prior surgical repair or revision arthroscopy; nonsurgical rotator cuff‐associated treatment during month prior to randomisation, including corticosteroid injection and antiinflammatory treatment; prior PRP injection; pre‐existing conditions associated with upper extremity pain, including arthritis, ongoing infection, carpal tunnel syndrome, cervical neuropathy or other nerve pathology, local malignancy, and systemic disorders (e.g. uncontrolled diabetes, hypothyroidism); gross shoulder instability; people with an active infection; women who are pregnant, or plan to become pregnant in the next 12 months; a preoperative platelet count < 125,000 and a preoperative haemoglobin of 7.5 g/dL or less; likely problems with follow‐up (i.e. people with no fixed address, or reporting a plan to move out of town, or intellectually‐challenged people without adequate family support); inability to read and speak English; participating in another ongoing trial that would interfere with the assessment of the primary or secondary outcomes in this trial; any other reason (in the judgment of the surgeon)
Interventions PRP: ACP ‐ details not reported
Controls or placebo or no intervention (standard care): saline ‐ details not reported
Outcomes Primary outcomes: pain score
 Secondary outcomes: adverse events; use of healthcare resources; physical function; revision surgery
 Timing of outcomes measurement: 6 weeks
Starting date Main ID: NCT01170312Date of registration: July 2010
Last refreshed on: November 2012
 Date of first enrolment: September 2010
 Status: completed
Contact information Name: Mohit Bhandari
 Address: not reported
 Telephone: not reported
 Email: not reported
 Affiliation: McMaster University
Notes