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临床试验/NCT07375277
NCT07375277招募中不适用

Effects Of Biceps Transposition Without Tenotomy For Augmentation Of Massive Rotator Cuff Repairs On Function, Quality Of Life, And Sleep: A Prospective Study

Balikesir Ataturk City Hospital1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2026年3月26日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
35
试验地点
1
主要终点
American Shoulder and Elbow Surgeons (ASES) Score

研究概览

简要总结

This prospective, single-arm interventional study will evaluate the effects of long head of the biceps tendon (LHBT) transposition without tenotomy as an augmentation technique for arthroscopic partial repair in adults with massive rotator cuff tears. Consecutive eligible patients undergoing arthroscopic partial rotator cuff repair plus tenotomy-sparing LHBT transposition augmentation at Balikesir City Hospital (Balikesir, Turkiye) will be enrolled and followed for 12 months. Patient-reported outcomes and clinical assessments will be collected preoperatively (baseline) and postoperatively at 3 and 12 months. The primary outcomes are shoulder function (ASES), rotator cuff-related quality of life (WORC converted to a 0-100 scale), and sleep disturbance (Insomnia Severity Index). Secondary outcomes include active shoulder range of motion and biceps-related clinical findings (Speed test, Yergason test, bicipital groove tenderness, and Popeye deformity). Postoperative MRI will not be obtained routinely and will be performed only if clinically indicated. The study aims to provide standardized prospective data on functional outcomes, quality of life, and sleep after this augmentation approach.

详细描述

Detailed Description Massive rotator cuff tears may not be amenable to full anatomic repair, and even when partial repair is feasible, residual symptoms and functional limitations may persist. Long head of the biceps tendon (LHBT) transposition without tenotomy has been proposed as an augmentation strategy that may provide additional biomechanical and biologic support to arthroscopic partial rotator cuff repair. However, prospective data with standardized follow-up evaluating functional outcomes, rotator cuff-specific quality of life, and sleep outcomes remain limited. This study is designed to generate prospective, standardized clinical and patient-reported outcome data after tenotomy-sparing LHBT transposition augmentation in the setting of massive rotator cuff repair.

This is a prospective, single-arm, non-randomized interventional clinical study conducted at Balikesir City Hospital, Department of Orthopedics and Traumatology (Balikesir, Turkiye). Consecutive eligible adult patients will be enrolled between January 2026 and December 2026, with a planned sample size of 35 participants. Each participant will be followed for a minimum of 12 months. Assessments will be performed preoperatively (baseline) and postoperatively at 3 months and 12 months.

Participants and Eligibility Massive rotator cuff tear will be defined on preoperative MRI as a full-thickness tear involving at least two tendons and/or a tear with the greatest dimension greater than 5 cm. Final eligibility will be confirmed intraoperatively when the tear pattern is deemed suitable for arthroscopic partial repair with LHBT augmentation. Inclusion criteria include age 18 years or older, persistence of symptoms despite at least 3 months of standard nonoperative treatment, planned arthroscopic partial repair with LHBT augmentation, intact LHBT at the time of surgery, and willingness to attend the scheduled follow-up visits. Exclusion criteria include tear patterns not requiring augmentation (e.g., preserved rotator cable patterns), conditions affecting shoulder function (e.g., relevant neurologic disease, inflammatory arthritis), active infection, systemic conditions preventing protocol rehabilitation, inability to provide informed consent, or expected nonadherence to follow-up.

Intervention and Standardization All surgeries will be performed arthroscopically under general anesthesia (with or without interscalene block per anesthesia protocol) in the beach-chair position. Standard diagnostic glenohumeral assessment and subacromial bursectomy will be performed. Acromioplasty may be performed routinely per the surgical standard. The rotator cuff will be mobilized and partially repaired to achieve acceptable tension. For augmentation, the LHBT will be confirmed intact and will not be tenotomized. The transverse humeral ligament will be released to mobilize the tendon. The tendon will be transposed posterior to the bicipital groove and directed to the superior aspect of the greater tuberosity, avoiding overtension. Fixation will be performed to the footprint region using a standardized anchor/suture technique to create an augmentation construct supporting the partial repair. Arthroscopic assessment will confirm absence of overtension and mechanical impingement. Concomitant procedures (e.g., subscapularis repair, distal clavicle resection) will be performed only when clinically indicated and will be recorded.

Rehabilitation Protocol Postoperative management will be standardized: sling immobilization for 3 weeks; passive range of motion initiated immediately in the early postoperative period within pain limits; active range of motion starting at postoperative week 4; strengthening at approximately postoperative month 3. Biceps loading will be restricted for the first 4 weeks (no resisted elbow flexion or supination), followed by gradual progression. Rehabilitation adherence and protocol deviations will be documented.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

This is an open-label, single-arm interventional study. Due to the nature of the surgical intervention, participants, care providers, investigators, and outcome assessors are not masked.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older
  • Diagnosis of a massive rotator cuff tear on preoperative MRI, defined as a full-thickness tear involving at least two tendons and/or a tear with a greatest dimension greater than 5 cm
  • Planned arthroscopic partial rotator cuff repair with augmentation using tenotomy-sparing long head of the biceps tendon (LHBT) transposition
  • Persistence of symptoms despite at least 3 months of standard nonoperative treatment
  • Intact LHBT confirmed intraoperatively
  • Willingness and ability to attend scheduled follow-up visits (baseline, 3 months, and 12 months)
  • Provision of written informed consent

排除标准

  • Exclusion Criteria:
  • Tear patterns not requiring augmentation (e.g., preserved rotator cable patterns)
  • Neurologic conditions, inflammatory arthritis, active infection, or systemic conditions that may affect shoulder function or prevent protocol rehabilitation
  • Inability to provide informed consent
  • Expected nonadherence to follow-up or rehabilitation protocol

研究组 & 干预措施

Biceps Transposition Augmentation

Other

Participants in this single arm undergo arthroscopic partial rotator cuff repair augmented with tenotomy-sparing transposition of the long head of the biceps tendon (LHBT). All procedures are performed according to a standardized surgical and rehabilitation protocol.

干预措施: LHBT Transposition Augmentation (Procedure)

结局指标

主要结局

American Shoulder and Elbow Surgeons (ASES) Score

时间窗: aseline, 3 months, and 12 months postoperatively

The ASES score is a validated patient-reported outcome measure assessing shoulder pain and function on a 0-100 scale, with higher scores indicating better shoulder function.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

güneş sarıkaya

Orthopedic Surgeon

Balikesir Ataturk City Hospital

研究点 (1)

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