Laboratory of Applied Biomechanics, Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy.
U.O.C. 1° Clinica Ortopedica, ASST Gaetano Pini-CTO, Milan, Italy.
Am J Sports Med. 2022 Apr;50(5):1344-1357. doi: 10.1177/03635465221083324. Epub 2022 Mar 18.
Autologous microfragmented lipoaspirate tissue has been recently introduced in orthopaedics as an easily available source of nonexpanded adipose-derived mesenchymal stem cells. Autologous microfragmented lipoaspirate tissue is expected to create a suitable microenvironment for tendon repair and regeneration. Rotator cuff tears show a high incidence of rerupture and represent an ideal target for nonexpanded mesenchymal stem cells.
To evaluate the safety and efficacy of autologous lipoaspirate tissue in arthroscopic rotator cuff repair.
Randomized controlled trial; Level of evidence, 2.
Consecutive patients referring to the investigation center for surgical treatment of magnetic resonance imaging-confirmed degenerative posterosuperior rotator cuff tears were assessed for eligibility. Those who were included were randomized to receive a single-row arthroscopic rotator cuff repair, followed by intraoperative injection of autologous microfragmented adipose tissue processed with an enzyme-free technology (treatment group) or not (control group). Clinical follow-up was conducted at 3, 6, 12, 18, and 24 months; at 18 months after surgery, magnetic resonance imaging of the operated shoulder was obtained to assess tendon integrity and rerupture rate.
An overall 177 patients were screened, and 44 (22 per group) completed the 24-month follow-up. A statistically significant difference in favor of the treatment group in terms of Constant-Murley score emerged at the primary endpoint at 6-month follow-up (mean ± SD; control group, 76.66 ± 10.77 points; treatment group, 82.78 ± 7.00 points; = .0050). No significant differences in clinical outcome measures were encountered at any of the other follow-up points. No significant differences emerged between the groups in terms of rerupture rate, complication rate, and number of adverse events.
This prospective randomized controlled trial demonstrated that the intraoperative injection of autologous microfragmented adipose tissue is safe and effective in improving short-term clinical and functional results after single-row arthroscopic rotator cuff repair.
NCT02783352 (ClinicalTrials.gov identifier).
自体微粉碎脂肪组织最近在骨科中被引入，作为一种易于获得的非扩张脂肪来源间充质干细胞。自体微粉碎脂肪组织有望为肌腱修复和再生创造合适的微环境。肩袖撕裂的发生率较高，且容易再次撕裂，是非扩张间充质干细胞的理想靶点。
评估关节镜下肩袖修复术中应用自体脂肪抽吸组织的安全性和疗效。
随机对照试验；证据等级 2。
连续评估因磁共振成像证实的退行性后上肩袖撕裂而就诊于调查中心的患者，以评估其是否符合入选条件。纳入的患者被随机分为接受单排关节镜肩袖修复术，然后在术中注射用酶免处理技术处理的自体微粉碎脂肪组织（治疗组）或不注射（对照组）。临床随访在术后 3、6、12、18 和 24 个月进行；术后 18 个月，对手术肩进行磁共振成像，以评估肌腱完整性和再撕裂率。
共筛选出 177 例患者，44 例（每组 22 例）完成了 24 个月的随访。在术后 6 个月的主要终点时，治疗组在 Constant-Murley 评分方面具有统计学意义的优势（均值±标准差；对照组，76.66±10.77 分；治疗组，82.78±7.00 分；=.0050）。在其他随访时间点，两组的临床疗效指标均无显著差异。两组在再撕裂率、并发症发生率和不良事件数量方面均无显著差异。
这项前瞻性随机对照试验表明，关节镜下单排肩袖修复术中注射自体微粉碎脂肪组织是安全有效的，可改善术后短期的临床和功能结果。
NCT02783352（ClinicalTrials.gov 标识符）。
