Gumina 2012.
Methods | Randomised controlled trial: allocation concealment derived from randomisation (sealed envelopes). Participants were followed for a mean of 13 months Trial conducted: Orthopaedic Clinic, University of Rome 'Sapienza', Rome, Italy; recruitment: from June‐December 2009 |
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Participants |
Participants: 80 undergoing arthroscopic repair of rotator cuff tears Included participants: reparable large full‐thickness posterosuperior rotator cuff tears Excluded participants: partial‐thickness tear; small or massive full‐thickness tear; traumatic tear; biceps instability; labral pathology amenable to surgical treatment; os acromiale; degenerative arthritis of the glenohumeral joint; autoimmune or rheumatologic disease; previous surgery in the same shoulder and Workers' compensation claims Age: PRT group mean (SD): 60 years (4.4) No PRT mean (SD): 63 years (5.9) Gender: PRT group (number of men:women): 20:19 No PRT (number of men:women): 21:16 Sports activity: not available |
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Interventions | All participants underwent arthroscopic rotator cuff repair PRT (number of participants = 40): single, intraoperative intervention (platelet‐leukocyte membrane), 10 mL blood was centrifuged for 10 minutes at 120 x g. The product was added to gluconate and batroxobin, for 20‐30 minutes (product is a platelet‐leukocyte membrane) PRT preparation: kit: RegenKit, Regen Lab, Le Mont‐Sur‐Lausanne, Switzerland) Quantification of platelet concentrates after preparation: white blood cells (7 x 103/mm3), platelet (> 400 x 103/mm3), 1.7 times greater than the normal level in whole blood. No PRT (number of participants = 40): no platelet‐rich therapy controls Co‐interventions: same rehabilitation protocol for both groups |
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Outcomes | Constant scores Simple Shoulder Test MRI (repair integrity): Sugaya classification |
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Other quality issues |
Sample size: a priori power calculations not available Validation of PRT: quantification reported |
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Notes | In the intervention group, 1 membrane was used for each repair anchor 4 follow‐up losses (1 in the PRT group), reasons not known The authors provided the study protocol/trial registration details, ID: ISRCTN93082180 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation | Unclear risk | Randomisation reporting was unclear |
Allocation concealment | High risk | The envelope was opened 3 days prior to surgery rather than during surgery |
Blinding All outcomes | Unclear risk | The study was probably not blinded |
Incomplete outcome data addressed All outcomes | Low risk | Missing outcome data were balanced in numbers across intervention groups |
Free of selective reporting | Low risk | The study protocol was available and all of the study’s prespecified (primary and secondary) outcomes that are of interest in the review have been reported in the prespecified way |
Free of other bias | Low risk | The study appears to be free of other sources of bias |