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临床试验/NCT03878862
NCT03878862招募中不适用

Surgical Treatment of Massive and Irreparable Rotator Cuff Tears

Panam Clinic1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年4月1日最近更新:
适应症

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

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

发起方
Panam Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter MacDonald

Orthopaedic surgeon

Panam Clinic

研究点 (1)

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