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Autologous Conditioned Plasma for tendon healing following arthroscopic rotator cuff repair. Prospective comparative assessment with magnetic resonance arthrography at 6 months' follow-up.
INTRODUCTION: Despite improvements in technique and materials for rotator cuff repair, mean re-tear rates remain close to 30%. The aim of the present study was to assess injection of Autologous Conditioned Plasma (ACP™, Arthrex) for tendon healing after arthroscopic repair. The study hypothesis was that ACP™ improves the tendon-healing rate.
MATERIAL AND METHOD: A non-randomized comparative prospective study included all patients aged over 18 years operated on in 2010 for arthroscopic repair of full-thickness rotator cuff tear with≤2 fatty degeneration on the Goutallier classification, whatever the severity of retraction, on virgin non-osteoarthritic shoulder without contraindications for magnetic resonance (MR) arthrography. The surgical protocol was standardized. The first half of the patient sample received end-of-procedure ACP™ injection to the repaired tendon, tuberosity freshening surface and subacromial space, and the second (control) half received no supplementary treatment. The main endpoint was tendon healing on MR arthrography at 6 months according to Sugaya. Secondary endpoints comprised shoulder pain at rest on a numerical scale (0=no pain to 10=worst imaginable pain) and Constant functional score.
RESULTS: Two of the 58 patients refused MR arthrography and 7 were lost to follow-up. Forty-nine patients (26 ACP™, 23 controls) were analyzed: 20 male, 29 female; mean age, 61±7.3 years. There were no significant intergroup differences in healing rate at 6 months (ACP™ 73.1% vs. 78.3% controls; p=0.75), shoulder pain (2±1.8 vs. 2.6±1.7, respectively; p=0.24), or Constant score (77±13.5/100 vs. 72.4±12.3, respectively; p=0.18).
CONCLUSION: Associating ACP™ did not improve healing after arthroscopic rotator cuff repair. Sample size, however, had been calculated for a large expected difference, leading to lack of power.
LEVEL OF EVIDENCE: III; case-control study.
MATERIAL AND METHOD: A non-randomized comparative prospective study included all patients aged over 18 years operated on in 2010 for arthroscopic repair of full-thickness rotator cuff tear with≤2 fatty degeneration on the Goutallier classification, whatever the severity of retraction, on virgin non-osteoarthritic shoulder without contraindications for magnetic resonance (MR) arthrography. The surgical protocol was standardized. The first half of the patient sample received end-of-procedure ACP™ injection to the repaired tendon, tuberosity freshening surface and subacromial space, and the second (control) half received no supplementary treatment. The main endpoint was tendon healing on MR arthrography at 6 months according to Sugaya. Secondary endpoints comprised shoulder pain at rest on a numerical scale (0=no pain to 10=worst imaginable pain) and Constant functional score.
RESULTS: Two of the 58 patients refused MR arthrography and 7 were lost to follow-up. Forty-nine patients (26 ACP™, 23 controls) were analyzed: 20 male, 29 female; mean age, 61±7.3 years. There were no significant intergroup differences in healing rate at 6 months (ACP™ 73.1% vs. 78.3% controls; p=0.75), shoulder pain (2±1.8 vs. 2.6±1.7, respectively; p=0.24), or Constant score (77±13.5/100 vs. 72.4±12.3, respectively; p=0.18).
CONCLUSION: Associating ACP™ did not improve healing after arthroscopic rotator cuff repair. Sample size, however, had been calculated for a large expected difference, leading to lack of power.
LEVEL OF EVIDENCE: III; case-control study.
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