Biceps Tenodesis With 360 Suture Anchor Versus Self-Locking Tenodesis in the Absence of Full-thickness Rotator Cuff Tears: Protocol for a Non-inferiority Randomized Controlled Trial (BLAST-2)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Constant score
研究概览
简要总结
This is a prospective randomized controlled trial. The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double-loop 360 lasso biceps tenodesis for the treatment of pathology of the long head of the biceps or superior labrum anterior-posterior (SLAP) during shoulder arthroscopy in patients without arthroscopic rotator cuff tears. Currently, there is no consensus on the use of tenodesis versus tenotomy to treat pathology of the long head of the biceps during arthroscopic rotator cuff repair. Numerous studies have examined the clinical results of long biceps tenotomy versus long biceps tenodesis, and there is no evidence to date of superiority of either technique. However, these studies were carried out on patients with rotator cuff tears, and so it has not been possible to directly compare the two procedures. At Clinique Générale, we use a new, innovative technique called autobloc tenodesis to treat pathologies of the long head of the biceps. There are no comparative studies between autobloc tenodesis of the biceps and biceps tenodesis in patients without rotator cuff tears. Given its potential advantages, autobloc biceps tenodesis could become the new technique of choice for treating biceps longus tendon pathology, potentially reducing differences in outcomes such as Popeye deformity. The information provided by this study could potentially guide future clinical practice, helping surgeons choose the most appropriate treatment for their patients with long biceps tendon pathology.
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 (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathology of the LHBT or SLAP-type lesion based on clinical symptoms
- •Partial-thickness rupture or absence of full-thickness rupture of the rotator cuff of the subscapular, supraspinatus and/or infraspinatus tendons, diagnosed preoperatively on ultrasound, arthro-CT or MRI
排除标准
- •Full-thickness tears of the rotator cuff diagnosed preoperatively on ultrasound, arthro-CT or MRI.
- •Osteoarthritis of the glenohumeral joint, defined by narrowing of the glenohumeral joint space or osteophytes, using AP radiography of the affected shoulder.
- •Previous surgery on the affected shoulder
- •Patients presenting with motor paralysis of the shoulder
- •Preoperative presence of the Popeye sign or documented LHBT rupture
- •Dementia or inability to complete questionnaires and assessments in French or English.
- •Pregnant or breast-feeding patient
- •Protected adult patient
- •Patient not covered by social security.
研究组 & 干预措施
self-locking biceps tenodesis
干预措施: self-locking biceps tenodesis (Procedure)
360° double-loop lasso biceps tenodesis
干预措施: Biceps Tenodesis with 360 Suture anchor (Procedure)
结局指标
主要结局
Constant score
时间窗: 1 year after surgery
100-point scale comprising four components, including a patient-reported section (pain 15 points and activity level 20 points), for a total of 35 points. Alongside this is a doctor-reported section (shoulder strength 25 points, range of motion 40 points) for a total of 65 points.
次要结局
- American Shoulder and Elbow Surgeons Score (ASES)(6 weeks, 3 months, 6 months, 1 year after surgery)
- Subjective Shoulder Value (SSV)(6 weeks, 3 months, 6 months, 1 year after surgery)
- LHB score(6 months, 1 year after surgery)
- cosmetic appearance(6 weeks, 3 months, 6 months, 1 year after surgery)
- VAS pain score(6 weeks, 3 months, 6 months, 1 year after surgery)
- Radiograph(Direct post-op, 6 weeks, 3 months, 6 months after surgery)
- MRI or Ultra-sound(1 year after surgery)
