Aurégan Jean-Charles, Klouche Shahnaz, Levy Bruno, Bauer Thomas, Rousselin Benoit, Ferrand Mathieu, Hardy Philippe
Hôpitaux universitaires Paris Île-de-France Ouest, AP-HP, 9, avenue Charles-de-Gaulle, 92100 Boulogne-Billancourt, France; Laboratoire de bioingénierie et bioimagerie ostéo-articulaire B2OA UMR7052, 10, avenue de Verdun, 75010 Paris, France.
Hôpitaux universitaires Paris Île-de-France Ouest, AP-HP, 9, avenue Charles-de-Gaulle, 92100 Boulogne-Billancourt, France.
Orthop Traumatol Surg Res. 2019 Apr;105(2):245-249. doi: 10.1016/j.otsr.2019.01.003. Epub 2019 Mar 8.
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.
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.
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).
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.
III; case-control study.
尽管肩袖修复技术和材料有所改进，但平均再撕裂率仍接近30%。本研究的目的是评估关节镜修复术后注射自体浓缩血浆（ACP™，Arthrex公司）对肌腱愈合的影响。研究假设是ACP™可提高肌腱愈合率。
一项非随机对照前瞻性研究纳入了2010年所有年龄超过18岁、接受关节镜下全层肩袖撕裂修复手术且Goutallier分级脂肪变性≤2级的患者，无论回缩程度如何，手术部位为初次发病的非骨关节炎性肩关节且无磁共振（MR）关节造影禁忌证。手术方案标准化。患者样本的前半部分在手术结束时接受向修复肌腱、骨突新鲜化表面和肩峰下间隙注射ACP™，后半部分（对照组）不接受补充治疗。主要终点是根据Sugaya标准在6个月时MR关节造影显示的肌腱愈合情况。次要终点包括静息时肩部疼痛的数字评分（0=无疼痛至10=可想象的最严重疼痛）和Constant功能评分。
58例患者中有2例拒绝MR关节造影，7例失访。对49例患者（26例接受ACP™治疗，23例为对照组）进行分析：男性20例，女性29例；平均年龄61±7.3岁。6个月时愈合率（ACP™组73.1% vs.对照组78.3%；p=0.75）、肩部疼痛（分别为2±1.8 vs. 2.6±1.7；p=0.24）或Constant评分（分别为77±13.5/100 vs. 72.4±12.3；p=0.18）在组间均无显著差异。
关节镜下肩袖修复术后联合使用ACP™并未改善愈合情况。然而，样本量是根据预期的较大差异计算的，导致检验效能不足。
III级；病例对照研究。
