Randomized Clinical Trial Comparing Rotator Cuff Repair (RCR) With Subacromial Balloon Spacer (SBS) Implantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 主要终点
- Study feasibility - surgery
研究概览
简要总结
The purpose of this pilot study is to assess the feasibility of a full randomized trial design.
详细描述
The feasibility objectives are:
-
Recruitment
-
To establish an estimate of the proportion of patients screened who are eligible for inclusion, and of those, the proportion who consent.
-
To establish an estimate of the proportion of eligible patients with medium/large tears versus massive tears.
-
Surgery -to confirm agreement among surgeons regarding the protocol's standardized surgical techniques of both groups.
Clinical objectives for observational purposes only are as follows:
- Patient reported and clinical outcomes.
- Number of "failures" in each group (defined as additional surgery and/or having <12% improvement in SANE score from baseline).
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)
盲法说明
Patients will be blinded to their group allocation. This is possible because the incision and rehabilitation processes are consistent between groups. It is not possible for the treating surgeon to be blinded to group allocation, therefore a research team member (athletic or physical therapist) will remain blinded to group allocation and conduct all study related assessments as well as administer the patient-reported questionnaires. This will be maintained by the participant not removing their shirt during the study assessment. Patients will not be informed of which procedure they will undergo until the study is complete.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •70 years of age or older
- •clinical and radiological diagnosis of a full thickness supraspinatus (or larger) RC tear >2cm or more than 1 full tendon
- •ongoing symptoms after 3 months of physiotherapy
- •a tendon amenable to partial or complete repair (as determined by pre-operative MRI)
- •absence glenohumeral arthritis (Hamada < 3)
- •absence of neoplastic diseases at treated site
排除标准
- •previous surgery or pseudoparalysis on study shoulder
- •complete subscapularis deficiency
- •external rotation lag signs
- •avascular necrosis
- •post-infectious arthritis
- •proximal humerus fracture
- •inflammatory arithritis
- •axillary nerve palsy
- •concomitant tendon transfer
- •neuromuscular disorder
- •unable to speak/read English
- •Intra-operative Exclusion:
- •tendon is NOT amenable to partial or complete repair
结局指标
主要结局
Study feasibility - surgery
时间窗: 1 year
Consensus among surgeon co-investigators regarding the standardized peri-operative orders and surgical techniques.
Study feasibility - recruitment
时间窗: 1 year
Number of screened patients and proportion that are deemed eligible that consent
Study feasibility - randomized
时间窗: 1 year
Percentage of patients randomized
次要结局
- EQ5D-3L(24 Months, post-operative)
- SANE Score(24 Months, post-operative)
- Constant Score(24 Months, post-operative)
- Isometric Strength(24 Months, post-operative)
- ASES Score(24 Months, post-operative)
- Range of Motion(24 Months, post-oeprative)