Treatment of the Biceps With Concomitant Supraspinatus Tears: A Multicenter Pragmatic Three-Arm Parallel-Group Randomized Surgical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 8
- 主要终点
- ASES score
研究概览
简要总结
The long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology. Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of choice. Some suggest that tenotomy should be reserved for older, low-demand patients, while tenodesis should be performed in younger patients and those who engage in heavy labor. Proponents of tenotomy suggest that this is a technically easy procedure that leads to easy rehabilitation and fast return to activity with a low complication and reoperation rate. However, those who support LHB tenodesis list good preservation of elbow flexion and supination strength, improvement of functional scores, elimination of pain, and avoidance of cosmetic deformity as benefits of the procedure. Alternatively, the LHB can be maintained in the joint without tenodesis or tenotomy. In fact, it has not been clearly shown that LHB tenodesis or tenotomy leads to improved outcomes compared to leaving the biceps tendon intact.
详细描述
The long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology.Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of choice. Some suggest that tenotomy should be reserved for older, low-demand patients, while tenodesis should be performed in younger patients and those who engage in heavy labor. Proponents of tenotomy suggest that this is a technically easy procedure that leads to easy rehabilitation and fast return to activity with a low complication and reoperation rate. However, those who support LHB tenodesis list good preservation of elbow flexion and supination strength, improvement of functional scores, elimination of pain, and avoidance of cosmetic deformity as benefits of the procedure. Alternatively, the LHB can be maintained in the joint without tenodesis or tenotomy. In fact, it has not been clearly shown that LHB tenodesis or tenotomy leads to improved outcomes compared to leaving the biceps tendon intact. The primary goal of this prospective multicenter randomized study is to evaluate whether LHB tenodesis grants superior post-operative functional outcomes compared to LHB tenotomy or leaving the LHB intact in patients undergoing rotator cuff repair (RCR) for an isolated full-thickness lesion of the supraspinatus. The primary goal of this prospective multicenter randomized study is to evaluate whether LHB tenodesis grants superior post-operative functional outcomes compared to LHB tenotomy or leaving the LHB intact in patients undergoing rotator cuff repair (RCR) for an isolated full-thickness lesion of the supraspinatus. The secondary goals are to determine whether there is a difference in post-operative functional outcomes between the LHB tenotomy group and the Intact LHB group, and if there is a difference in complication rates or patient satisfaction between the three groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
- •Full thickness tear of the supraspinatus tendon
- •Intact subscapularis tendon
- •Primary rotator cuff repair
- •Age 50-80
排除标准
- •Previous full thickness biceps tear
- •Infection and neuropathic joints
- •Known or suspected non-compliance, drug or alcohol abuse
- •Patients incapable of judgement or under tutelage
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for MRI scan etc.
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Patient declines to participate in study
研究组 & 干预措施
Leaving LHB Intact
The long head of the biceps (LHB) will be left intact.
LHB Tenodesis
The long head of the biceps (LHB) will be cut at its origin and reattached.
干预措施: LHB Tenodesis (Procedure)
LHB tenotomy
The long head of the biceps (LHB) will be cut at its origin.
干预措施: LHB Tenotomy (Procedure)
结局指标
主要结局
ASES score
时间窗: At 24 post-operative months
American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).
次要结局
- Complications(Within 2 postoperative years)
- LHB score(At 24 post-operative months)
- IR(At 24 post-operative months)
- VAS pain(At 24 post-operative months)
- SSV(At 24 post-operative months)
- AFF(At 24 post-operative months)
- ER at side(At 24 post-operative months)
- Number of patients with liquid in the bicipital sheath(At 6 post-operative month)
- Number of patients with hypervascularization of the sheath(At 6 post-operative month)
- Patient satisfaction(At 24 post-operative months)
- Status of the biceps tendon (intact | in continuity | defect)(At 6 post-operative month)
- Signs of anchor displacement and location (lateral | medial row).(At 6 post-operative month)
- Number of patients with bursitis(At 6 post-operative month)
- Location of the defect (at the foot print | medial cuff failure)(At 6 post-operative month)
- Tendon thickness(At 6 post-operative month)
- Number of patients with healing of the Supraspinatus tear according to Sugaya classification(At 6 post-operative month)
研究者
Dr. Alexandre Lädermann
Orthopaedic Surgeon FMH, Shoulder and Elbow Surgery Traumatology
La Tour Hospital