Evaluation of Rotator Cuff Repair With Long Head of the Biceps Reinforcement: a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual analogue score (VAS)
研究概览
简要总结
The increase of the population life expectancy and the active lifestyle adopted in recent years have contributed to the higher incidence of rotator cuff injuries. For large (>3 cm) and extensive (>5 cm) injuries of the rotator cuff, even after complete or partial repair, the chances of failure reach 94%.
An alternative in rotator cuff injuries is the use of the long head of the biceps (LHB) as an autologous graft to increase the healing rate and the final outcomes.
The primary objective is to compare the functional results, according to the ASES score, between patients who use or not the long head biceps brace for complete repairs of large and extensive rotator cuff tears.
The secondary objectives are to compare the groups according to structural results by MRI and functional results by the UCLA score.
详细描述
A prospective randomized study will be carried out in a 1:1 ratio between groups. Patients with large and extensive rotator cuff injuries will be selected at the Shoulder and Elbow clinic of Pedro Ernesto University Hospital (HUPE-UERJ), during outpatient care.
Patients with an intact long head of the biceps will be randomized into two groups, according to the use or not of the tendon: complete repair with LHB tendon reinforcement and complete repair without reinforcement. All patients will be operated by the same surgeon.
All selected patients will be explained what the research is about by a research assistant not involved in the treatment and will be offered the option to participate or not.
The "American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form" (ASES) scale will be adopted as the primary outcome. The "Modified University of California at Los Angeles Shoulder Rating Scale" (UCLA) and the assessment of tendon healing with magnetic resonance imaging at 6 months after surgery, using the classification of Sugaya et al. will be secondary outcomes.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Long head tendon of biceps intact;
- •Large or extensive posterosuperior rotator cuff injuries according to the classification of DeOrio and Cofield;20
- •Fatty degeneration of the ≦2 supraspinatus muscle according to the classification of Goutallier.21
排除标准
- •Active or previous infection in the affected shoulder;
- •Patients unable to understand preoperative questionnaires;
- •Patient who does not undergo at least 1 postoperative evaluation.
- •Injury where complete repair of the rotator cuff is not possible;
- •Rupture of the LHB tendon diagnosed intraoperatively.
研究组 & 干预措施
complete repair with LHB tendon reinforcement
complete repair with LHB tendon reinforcement
干预措施: LHB tendon reinforcement (Procedure)
complete repair without reinforcement
complete repair without reinforcement.
干预措施: complete repair without reinforcement (Procedure)
结局指标
主要结局
Visual analogue score (VAS)
时间窗: 24 months
Visual analogue score: it is a 10 cm line with two end points, one representing "no pain" and the other representing "worst pain". The patient marks the line to indicate their current pain level, and the distance from the "no pain" marker to the mark is measured in centimeters to provide a score. A higher score indicates greater pain intensity.
Structural outcomes
时间窗: 24 months
Patients will undergo preoperative MRI and from 6 months after the procedure. All images will be evaluated by at least two authors of the work, who will not know which group the patients belong to. The classification by Sugaya et al. stratifies the appearance of the tendon after repair into 5 types: type I (sufficient thickness with low signal in all images); type II (sufficiently thick with high focal signal); type III (insufficient thickness without discontinuity); type IV (small size tear) and type V (medium or large size tear). The healing of the long head biceps reinforcement will also be evaluated by MRI and classified as unhealed and healed.
American Shoulder and Elbow Score (ASES)
时间窗: 24
American Shoulder and Elbow Score score ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function.
The University of California-Los Angeles (UCLA)
时间窗: 24 months
Scores ranged from 0 to 35 with a score of 0 indicating worst shoulder function and 35 indicating best shoulder function.
The 12 item Short Form Survey (SF-12)
时间窗: 24 months
This is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. Utilize the norm-based scoring system to interpret Physical component and Mental component scores, with a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
次要结局
未报告次要终点
研究者
GUSTAVO DE MELLO RIBEIRO PINTO
Principal investigator
Hospital Universitario Pedro Ernesto