Long Head Biceps Tenodesis or Tenotomy in Arthroscopic Rotator Cuff Repair: An International Multicenter Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 17
- 主要终点
- Shoulder function quantified with the Constant score (0-100)
研究概览
简要总结
During arthroscopic rotator cuff (infraspinatus/supraspinatus) repair, biceps tendon lesions are frequently encountered. However, the most optimal treatment of the diseased long head of the biceps (LHB) tendon during rotator cuff repair remains a topic of debate: tenotomy or tenodesis. The hypothesis is that there is no difference in functional outcome between LHB tenotomy and LHB tenodesis when performed in adjunct to arthroscopic rotator cuff repair.
详细描述
Patients older than 50 years with a supraspinatus and/or infraspinatus tendon rupture sized smaller than 3cm, who are encountered with LHB pathology, will be randomized to either LHB tenotomy or LHB tenodesis. Clinical and self-reported data will be collected pre-operatively, and 6 weeks, 3 months, and 1 year after surgery.
Primary outcome is overall shoulder function evaluated with the Constant score. As additional measures of shoulder function, the Dutch Oxford Shoulder Test and the Disabilities of the Arm Shoulder and Hand questionnaire will be assessed. Other evaluations include cosmetic appearance evaluated by the ''Popeye'' deformity, arm cramping pain, elbow flexion strength, MRI evaluation, quality of life, and cost of surgery. To detect non-inferiority with a one-sided, two-sample t-test with a 80% power and a significance level (alpha) of 0.025, the required sample size is 98 patients.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients older than 50 years
- •Degenerative rotator cuff lesion of supraspinatus/infraspinatus tendon, smaller than three centimeter.
- •Patients need to be able to read and write in Dutch or English language in order to complete the questionnaires, and sign informed consent.
排除标准
- •Acute, traumatic or partial thickness rotator cuff rupture, or in case a full thickness tear is larger than 3 cm measured using an arthroscopic ruler.
- •Accompanying subscapularis tendon lesion
- •Hour-glass deformation bicepstendon origin or in case of accompanying subscapularis tendon rupture.
- •Osteoarthritis of the glenohumeral joint
- •Acromion to humeral head distance measuring 6mm or smaller.
- •Prior surgery to the involved shoulder
- •Dementia or inability to complete questionnaires and assessments
研究组 & 干预措施
@ Cuff repair with LHB tenodesis
In case of pathologic changes of the long Head Biceps tendon, a tenodesis is performed in adjunct to performing an arthroscopic rotator cuff repair.
干预措施: Arthroscopic rotator cuff repair (Procedure)
@ Cuff repair with LHB tenodesis
In case of pathologic changes of the long Head Biceps tendon, a tenodesis is performed in adjunct to performing an arthroscopic rotator cuff repair.
干预措施: LHB Tenodesis (Procedure)
@ cuff repair with LHB tenotomy
In case of pathologic changes of the long Head Biceps tendon, a tenotomy is performed in adjunct to performing an arthroscopic rotator cuff repair.
干预措施: Arthroscopic rotator cuff repair (Procedure)
@ cuff repair with LHB tenotomy
In case of pathologic changes of the long Head Biceps tendon, a tenotomy is performed in adjunct to performing an arthroscopic rotator cuff repair.
干预措施: LHB Tenotomy (Procedure)
结局指标
主要结局
Shoulder function quantified with the Constant score (0-100)
时间窗: 1 year
Sum of the items below: ADL: Patient reported shoulder function during work (0-4), recreation/sports (0-4), and sleep (0-2). Pain: Patient reported pain in the shoulder (severe=0,moderate=5,mild=10,no pain=15). ROM: Anteflexion up to waist(2)/xiphoid process(4)/neck(6)/head(8)/above head(10) Elevation in degrees: 0-30(0)/31-60(2)/61-90(4)/91-120(6)/121-150(8)/151-180(10) Abduction in degrees: 0-30(0)/31-60(2)/61-90(4)/91-120(6)/121-150(8)/151-180(10) External rotation: impossible to reach head with hand(0)/hand behind head-elbow forward(2)/hand behind head-elbow backward(4)/hand on head-elbow forward(6)/hand on head-elbow backward(8)/full elevation hand from head(10) Internal rotation: dorsal part of the hand reaching lateral thigh(0)/buttock(2)/lumbo-sacral junction(4)/L3(6)/Th12(8)/between scapulae(10). Abduction force at 90 degrees in pounds (max. 25)
次要结局
- Elbow flexion strength(1 year)
- Popeye phenomenon(1 year)
- Cosmetic appearance(1 year)
- Self-reported shoulder function(1 year)
- Duration of surgery(1 year)
- MRI-based location of the biceps tendon(1 year)
- Pain(1 year)
- Quality of life(1 year)
- Complications(1 year)
- Post-operative status of rotator cuff(1 year)
研究者
DFP van Deurzen
Orthopedic Surgeon
Onze Lieve Vrouwe Gasthuis