背景:全厚度肩袖撕裂(FTRCT)是一种常见的肩关节损伤,如果不治疗,可以在尺寸上进步,变得越来越痛苦,和抑制功能。这些病变通常通过手术修复,对于较大的眼泪,通常首选双排关节镜修复。已经开发了生物增强技术,以提高术后影像学再撕裂率,并增强FTRCT手术修复后患者报告的结果。这项研究试图证实,生物诱导性牛胶原蛋白植入物的增强修复可带来良好的再撕裂率和患者预后,随访2年。
方法:进行了一项前瞻性多中心队列研究,以确定使用生物诱导性牛胶原蛋白植入物增强FTRCT单排或双排关节镜修复的有效性和安全性。在115名成年患者中,66(57.4%)具有中等(1-3cm)的撕裂,49(42.6%)具有大(3-5cm)的撕裂。进行磁共振成像和患者报告的结果(肩肘外科[ASES]肩关节评分和Constant-Murley评分[CMS]),并在基线记录,3个月,1年,和2年。
结果:平均随访时间为2.1年(范围,1.5-2.9年)。在基线和2年随访之间,对于中等撕裂,冈上肌腱的平均总厚度增加了12.5%,对于大撕裂,增加了17.1%。在7/61可用的中等撕裂患者(11.5%)中发现了X线照相再撕裂,14/40患者(35.0%)伴有大泪液。在这两组中,这些眼泪主要发生在3个月随访前(13/21[61.9%]).采用补充的双排(DR)修复技术的射线照相再撕裂总体为13.2%(12/91DR患者;中等撕裂为11.3%,大撕裂为15.8%)。对于ASES和CMS,>90%的具有中等和大泪液的患者实现了最小的临床重要差异(MCID)。治疗外科医生将2例严重不良事件分类为可能与装置和/或手术有关(1例肿胀/引流和1例间歇性疼痛)。9例患者(7.8%;4例中等撕裂和5例大撕裂)需要再次手术索引肩袖手术。
结论:本研究的最后2年数据证实,在关节镜下双排FTRT修复中使用该植入物可提供良好的影像学再撕裂率和实质性功能恢复。还进一步支持了装置的相对安全性。
BACKGROUND: Full-thickness rotator cuff tears (FTRCTs) represent a common shoulder injury that, if untreated, can progress in size, become increasingly painful, and inhibit function. These lesions are often surgically repaired, with double-row arthroscopic repair often preferred for larger tears. Biological augmentation technologies have been developed to improve rates of postoperative radiographic re-tear and enhance patient-reported outcomes after surgical FTRCT repair. This
study sought to confirm that augmented repair with a bioinductive bovine collagen implant results in favorable re-tear rates and patient outcomes with follow-up to 2 years.
METHODS: A prospective multicenter cohort
study was undertaken to determine the efficacy and safety of augmenting single- or double-row arthroscopic repair of FTRCTs with a bioinductive bovine collagen implant. Of 115 adult patients participating, 66 (57.4%) had medium (1-3 cm) tears and 49 (42.6%) had large (3-5 cm) tears. Magnetic resonance imaging and patient-reported outcomes (Shoulder and Elbow Surgeons [ASES] Shoulder Score and Constant-Murley Score [CMS]) were performed and recorded at baseline, 3 months, 1 year, and 2 years.
RESULTS: Mean duration of follow-up was 2.1 years (range, 1.5-2.9 years). Between baseline and 2-year follow-up, mean total thickness of the supraspinatus tendon increased by 12.5% for medium tears and by 17.1% for large tears. Radiographic re-tear was noted in 7/61 available patients (11.5%) with medium tears, and in 14/40 patients (35.0%) with large tears. In both groups, these tears primarily occurred before the 3-month follow-up visit (13/21 [61.9%]). Radiographic re-tear with the supplemented double-row (DR) repair technique was 13.2% overall (12/91 DR patients; 11.3% for medium tears and 15.8% for large tears). The minimal clinically important difference (MCID) was achieved by >90% of patients with both medium and large tears for both ASES and CMS. There were 2 serious adverse events classified by the treating surgeon as being possibly related to the device and/or procedure (1 case of swelling/drainage and 1 case of intermittent pain). Nine patients (7.8%; 4 medium tears and 5 large tears) required reoperation of the index rotator cuff surgery.
CONCLUSIONS: Final 2-year data from this
study confirm that using this implant in augmentation of arthroscopic double-row repair of FTRCTs provides favorable rates of radiographic re-tear and substantial functional recovery. The relative safety of the device is also further supported.