Massive and Irreparable Rotator Cuff Tears Treated by Arthroscopic Partial Repair and Partial Repair With Long Head of the Biceps Tendon Augmentation. Comparison of Clinical and Radiological Findings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Comparison of improvement in shoulder strength
研究概览
简要总结
Management of massive rotator cuff tears (MRCT) is associated with high rates of failure. The long head of the biceps tendon augmentation (LHBTA) by reinforcement of the reconstruction and additional blood supply may improve healing and provide better outcome than partial repair only.
详细描述
Patients with irreparable supraspinatus muscle (SSP) tear, and complete infraspinatus muscle (ISP) tear are including in the prospective, comparative study. Excluding criteria consist of: problems or previous surgery of contralateral shoulder, subscapularis muscle tear larger than stage 2 by Lafosse classification, uncontrolled diabetes and previous surgery. First group consisting of patients treated by partial cuff repair with LHBTA. Second group is comparative group consisting of patients treated by only partial cuff repair without LHBTA. Group stratification depends on quality of the biceps tendon. In case of good tendon quality - its used for biological augmentation, if it's degenerated- tenotomy of the tendon and only partial repair is performing. Irreparability is defined as SSP ≥ 3 in Goutallier classification and stage 3 in Patte classification what is preoperatively assessed by MRI. Assessment tools consisting of range of motion (ROM), strength measurements in position adequate to assess reconstructing tendons and muscles force, Acromio-humeral index (AHI), Constant, SST, Hamada, and Sugaya scores. Goutallier classification for SSP and ISP and diameter of the teres minor muscle (TMn). Radiological and clinical assessment is performing one year after the surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Massive and irreparable rotator cuff tear:
- •chronic supraspinatus tear with retraction grade 3 and muscle fatty infiltration ( measured in MRI ) > 3*
- •Infraspinatus tear with retraction and fatty muscle degeneration
排除标准
- •Previosus surgery
- •Imposibility to performed MRI
- •no compliance
结局指标
主要结局
Comparison of improvement in shoulder strength
时间窗: Through study completion, an average of 2.5 years
Strength will be measured by dynamometer in Kilograms \[Kg\] by main investigator in external rotation position, flexion, abduction and Jobe test position for every patient at the end of the study. Comparison of two methods will be perform to assess better method for shoulder strength improvement
Comparison of improvement in shoulder pain in VAS score
时间窗: Through study completion, an average of 2.5 years
Pain is assessed preoperatively and postoperatively using VAS score ( from 0 to 10, when 0 is no pain and 10 is the higher possible pain). Comparison of two methods will be perform to assess better method for shoulder pain reduce.
Comparison of shoulder function measured in Constant-Murley Score
时间窗: Through study completion, an average of 2.5 years
Function of the shoulder will be assess by Constant Murlay score which describes shoulder function in daily routines: In this score range is 0-100 when 100 is the best result.
Comparison of shoulder function measured in SST Score
时间窗: Through study completion, an average of 2.5 years
Function of the shoulder will be assess by SST score which describes shoulder function in daily routines: In this score range is 0-100% when 100% is the best result.
Comparison of improvement in shoulder range of motion
时间窗: Through study completion, an average of 2.5 years
Range of motion ( ROM) of every patient is measured preoperatively and postoperatively using goniometer and the result is presented in degrees. Comparision of two methods will be perform to assess better method for ROM improvement
次要结局
- Comparison of radiological outcome in Hamada score(Through study completion, an average of 2.5 years)
- Comparison of radiological outcome in Sugaya score(Through study completion, an average of 2.5 years)
研究者
Hubert Laprus
Hubert Laprus, MD, Principal investigator. Department of Orthopaedic Surgery
Saint Lucas Hospital, Poland