背景:肩袖(RC)病理被认为是肩关节残疾和疼痛的最常见原因。关节镜下修复RC撕裂已被证明是一种有效的手术。不愈合和再撕裂仍然是重要的临床问题和对外科医生的挑战。此外,增强RC腱-骨愈合的必要生物增强剂仍在研究中。该研究的目的是评估在关节镜下修复全层RC泪液中注射去胶原和脱细胞真皮基质(ADM)同种异体移植物的安全性和有效性。
方法:从2018年1月至2020年3月,共129例全厚度RC撕裂患者,仅通过关节镜修复(Ⅰ组,n=36,平均年龄=63.2岁),关节镜下修复术联合去端胶原1ml注射(Ⅱ组,n=44,平均年龄=63岁),或RC泪液与ADM同种异体移植1ml注射(Ⅲ组,n=49,平均年龄=64.6岁)。对它们进行了前瞻性研究。这项研究包括冈上肌腱大小<5cm的可修复全层撕裂的患者。我们排除了肩胛骨下肌腱孤立性撕裂的患者,那些以前做过肩部手术的人,以及那些接受任何类型注射不到六周的人。美国肩肘外科医师得分,恒定肩关节评分,视觉模拟量表疼痛评分,术前评估活动范围,在术后3、6、12个月,以及最后的后续行动。此外,在术后2个月和12个月进行磁共振成像(MRI).
结果:平均随访时间为20个月。在最后的随访中,所有组的功能和疼痛评分均有改善,但3组疗效无明显差异(P>0.05)。两个月后,Ⅰ组无愈合率为11%(4/36),Ⅱ组4%(2/44),Ⅲ组为2%(1/49)(P>0.05)。Ⅰ组12个月后再撕裂率为19.4%(7/36),Ⅱ组13.6.7%(6/44),Ⅲ组为20.4%(10/49)(P>0.05)。在任何组中均未检测到不良事件。
结论:我们的研究显示,与对照组相比,在12个月的随访中,关节镜下RC修复中注射异体骨胶原和同种异体ADM的临床或放射学结果未优于对照组。然而,未观察到与去端胶原和ADM同种异体移植物注射相关的不良事件.
BACKGROUND: Rotator cuff (RC) pathologies are considered the most common cause of shoulder disability and pain. Arthroscopic repair of RC tears has proven to be an effective operation. Nonhealing and retear remain significant clinical problems and a challenge to surgeons. In addition, the essential biological augment to enhance RC tendon-bone healing is still under research. The purpose of the study was to assess the safety and efficacy of injection of
atelocollagen and acellular dermal matrix (ADM) allograft in arthroscopic repair of full-thickness RC tears.
METHODS: From January 2018 to March 2020, a total of 129 patients with full-thickness RC tear were treated by arthroscopic repair only (group 1, n = 36, with a mean age = 63.2 years), arthroscopic repair together with
atelocollagen 1-mL injection (group 2, n = 44, with a mean age = 63 years), or RC tears together with ADM allograft 1-mL injection (group 3, n = 49, with a mean age = 64.6 years). They were prospectively studied. This study included patients with a repairable full-thickness tear of the supraspinatus tendon size <5 cm. We excluded patients with isolated tears of the subscapularis tendon, those with a previous shoulder surgery, and those who had any type of injection for less than 6 weeks. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form score, Constant Shoulder score, visual analog scale pain score, and range of motion were evaluated preoperatively, at 3, 6, and 12 months of the postoperative period and the final follow-up. In addition, magnetic resonance imaging was performed at 2 months and 12 months postoperatively.
RESULTS: The mean follow-up period was 20 months. All groups showed improvement in functional and pain score at the final follow-up; however, there is no superior outcome among the 3 groups (P > .05). After 2 months, the nonhealing rate was 11% (4 of 36) for group 1, 4% (2 of 44) for group 2, and 2% (1 of 49) for group 3 (P > .05). The retear rates after 12 months was 19.4% (7 of 36) for group 1, 13.6% (6 of 44) for group 2, and 20.4% (10 of 49) for group 3 (P > .05). Adverse events were not detected in any groups.
CONCLUSIONS: Our study did not show superior clinical or radiologic outcomes of
atelocollagen and ADM allograft injections in arthroscopic RC repair over 12 months of follow-up in comparison to the control group. However, adverse events related to
atelocollagen and ADM allograft injection were not observed.