Surgical Treatment of Massive and Irreparable Rotator Cuff Tears
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Visual analog scale for pain
研究概览
简要总结
The primary goal will be to compare the early postoperative recovery outcomes and complications from a series of surgical treatments for massive or irreparable rotator cuff tears. The secondary goal will be to assess factors that impact the outcomes of these reconstructions for irreparable posterosuperior rotator cuff tears.
详细描述
Prospective, Non-Randomized Cohort Study The surgeons will decide which surgical reconstruction technique should be used to treat patients who have a massive (2+ tendons) or irreparable (Grade 3 or higher fatty infiltration into infraspinatus tendon) rotator cuff tear in the primary or revision setting. Surgical options include arthroscopic superior capsular reconstruction (SCR), arthroscopic assisted latissimus dorsi transfer (aaLDT), or arthroscopic assisted lower trapezius transfer (aaLTT), with arthroscopic biceps tendoesis/tenotomy as a control group.
Each patient will receive an X-ray and MRI to indicate reparable subscapularis tear, teres minor pathology, grade of muscle fatty infiltration, AHI, CSA, Hamada grade, and arthritis grade.
Patients will be assessed pre-operatively and again post-operatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months to collect patient reported outcomes and complications. Assessments will include clinical and shoulder motion evaluations to gauge shoulder range of motion and pathology, as well as questionnaires that evaluate the patients shoulder mobility, ability, pain, and surgical satisfaction. Any adverse events post surgery will also be recorded at the defined assessment time intervals (6 wks, 3m, 6m, 12m, 24,m) and will specifically monitor temporary or permanent nerve injuries, hematomas, superficial and deep infections, recurrent moderate/severe pain, tendon or graft rupture, and humeral head superior migration.
Graphical comparisons will be made of the patient's recovery for each surgical technique as well as an analysis of patient specific factors based on their demographics forms which could influence the recovery curves.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •massive (2+ tendons) or irreparable (see below) rotator cuff tears in the primary or revision setting.
- •Definition of "irreparable": grade 3 or higher fatty infiltration into the infraspinatus
- •Exclusion criteria:
- •Protected populations: prisoners, military, non-English speakers, age <18 years
排除标准
- 未提供
结局指标
主要结局
Visual analog scale for pain
时间窗: 24-months
10 cm scale with 0 = no pain and 10= extreme pain
Simple shoulder test
时间窗: 24-months
A validated score of items whereby patients indicate ability to perform or not with a lower score equal to worse outcomes. Maximum 12
Veterans Rand - 12
时间窗: 24-months
A validated general health survey with 0 as a poor outcome and 100 as a positive outcome.
American Shoulder and Elbow Score
时间窗: 24-months
Validated shoulder and elbow outcome with a maximum score of 30, with 0 being poor outcome and 30 being the most positive outcome
Western Ontario Rotator Cuff score
时间窗: 24-months
A validated measure with 0 as a poor score and 100 as a positive score.
次要结局
未报告次要终点
研究者
Peter MacDonald
Orthopaedic surgeon
Panam Clinic
