Henssler Leopold, Zeman Florian, Akgün Doruk, Thiele Kathi, Pauly Stephan, Greiner Stefan, Voss Andreas, Gerhardt Christian, Lehmann Lars-Johannes, Huppertz Gunnar, Elsner Magdalena, Alt Volker, Koller Michael, Kerschbaum Maximilian
Department of Trauma Surgery, University Hospital Regensburg, Franz-Josef-Strauss-Allee 11, Regensburg, 93053, Germany.
Center for Clinical Studies, University Hospital Regensburg, Franz-Josef-Strauss-Allee 11, Regensburg, 93053, Germany.
BMC Musculoskelet Disord. 2025 Jun 6;26(1):567. doi: 10.1186/s12891-025-08818-2.
Pathologies of the long head of the biceps (LHB) tendon are frequently seen as concomitant pathologies during arthroscopic surgery for rotator cuff injuries or the labroligamentous complex of the shoulder. Currently, there are two treatment options: Tenotomy is quick and easy to perform with low complications rates, but has limited functional results, especially in demanding patients; tenodesis of the tendon has shown beneficial cosmetic and functional results, but usually requires an implant for tendon-to-bone attachment and, therefore, carries the risk of implant-related complications. The implant-free loop tenodesis (LT) procedure was developed to combine the advantages of both treatment modalities and has shown promising functional and cosmetic results in a prospective pilot study. This study aims to establish the implant-free LT procedure versus arthroscopic anchor tenodesis (AAT) for the treatment of LHB pathologies during shoulder arthroscopy in terms of structural and functional outcome.
A national multi-center, two-arm, parallel-group, randomized, controlled, non-inferiority trial will be conducted. Patients are eligible for trial participation if they are at least 18 years of age and present to one of the five enrolling centers with LHB tendon-associated complaints and MRI-confirmed LHB tendinopathy, instability due to SLAP or pulley lesions, or partial rupture. Patients with current or previous shoulder injury that would interfere with post-treatment rehabilitation or study assessment will be excluded from study participation. Participating patients will be randomized 1:1 to receive either LT or AAT and will be followed up for 24 months after surgery. The primary endpoint will be the functional and cosmetic outcome as assessed by the biceps-specific LHB score at 12 months after surgery. Secondary outcomes include assessment of surgery-related complications, overall shoulder and arm function, and structural outcome as evaluated by ultrasound and an additional MRI scan at the final study visit.
The study will evaluate whether the implant-free loop tenodesis procedure is non-inferior to arthroscopic implant-based tenodesis in terms of functional and cosmetic results at 12 months post-treatment.
Trial was prospectively registered at the German Clinical Trials Register (DRKS) on 12 June 2024, Registration-ID DRKS00034361, https://drks.de/search/de/trial/DRKS00034361 .
肱二头肌长头（LHB）肌腱病变在肩袖损伤或肩关节盂唇韧带复合体的关节镜手术中常作为伴随病变出现。目前有两种治疗选择：肌腱切断术操作快速简便，并发症发生率低，但功能效果有限，尤其对于要求较高的患者；肌腱固定术已显示出良好的外观和功能效果，但通常需要植入物来实现肌腱与骨的附着，因此存在植入物相关并发症的风险。无植入物环行肌腱固定术（LT）是为了结合两种治疗方式的优点而开发的，在前瞻性试点研究中已显示出有前景的功能和外观效果。本研究旨在比较无植入物LT手术与关节镜下锚定肌腱固定术（AAT）在肩关节镜检查期间治疗LHB病变的结构和功能结果。
将进行一项全国多中心、双臂、平行组、随机、对照、非劣效性试验。如果患者年龄至少18岁，因LHB肌腱相关症状就诊于五个入组中心之一，且MRI证实为LHB肌腱病、因SLAP或滑车损伤导致的不稳定或部分撕裂，则符合试验参与条件。目前或既往有肩部损伤且会干扰治疗后康复或研究评估的患者将被排除在研究参与之外。参与研究的患者将按1:1随机分组，接受LT或AAT治疗，并在术后随访24个月。主要终点将是术后12个月通过特定于肱二头肌的LHB评分评估的功能和外观结果。次要结局包括评估手术相关并发症、整体肩部和手臂功能，以及在最终研究访视时通过超声和额外的MRI扫描评估的结构结果。
该研究将评估无植入物环行肌腱固定术在治疗后12个月的功能和外观结果方面是否不劣于关节镜下基于植入物的肌腱固定术。
该试验于2024年6月12日在德国临床试验注册中心（DRKS）进行前瞻性注册，注册号DRKS00034361，https://drks.de/search/de/trial/DRKS00034361 。
