Arthroscopic Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique: A Randomized Blinded Outcomes Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Return to Function
研究概览
简要总结
This study is a single-blind, randomized study evaluating the 6 month and 2 year outcomes of patients treated with arthroscopic rotator cuff repair using one of two techniques. One technique used is the standard double row repairs utilizing medial and laterally based anchor fixation and the other technique is the standard double row repairs utilizing medial and laterally based anchor fixation with the use of plateley rich fibrin membrane (PRFM). It is hypothesized that patients undergoing the surgery with the PRFM will report a higher quality of life than the patients that do not receive this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Evidence of a rotator cuff tear as determined by clinical examination and diagnostic imaging (MRI)
- •Patient undergoes arthroscopic rotator cuff repair
- •Age 18 or older
排除标准
- •Pre-operative exclusion criteria
- •Patient has had a previous arthroscopic rotator cut repair
- •A previous diagnosis of Rheumatoid Arthritis
- •Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder, or previous surgery of the affected shoulder,
- •Evidence of significant rotator cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations,
- •Medical device that would exclude the patient from having a MRI, including a pacemaker, cardiac defibrillator, aneurysm clips, carotid artery clamp, neurostimulator, insulin or infusion pump, implanted drug infusion device, bone growth/fusion stimulator, or ear implant.
- •Major medical illness (life expectancy less then 2 years or unacceptably high operative risk),
- •Inability to speak or read English
- •Psychiatric illness that precludes informed consent.
- •Pregnant patients.
- •Age 17 or younger
- •Unwillingness to be followed for 2 years.
- •Bilateral Rotator cuff tear confirmed by clinical exam and MRI
- •Patients enrolled in the study who demonstrate retear on clinical exam and MRI, then elect for a repeat surgery.
- •Intra-operative exclusion criteria (Note: This information will be collected during the chart audit and patients will be excluded from the study at that time.)
- •Irreparable cuff tears or tears extending into the subscapularis or teres minor
- •Isolated teres minor or subscapularis tears.
- •Inelastic and immobile tendon which cannot be advanced to articular margin
研究组 & 干预措施
Double Row
Double Row
干预措施: Double Row (Procedure)
Double Row with PRFM
Double Row with PRFM
干预措施: PRFM (Device)
Double Row with PRFM
Double Row with PRFM
干预措施: Double Row (Procedure)
结局指标
主要结局
Return to Function
时间窗: 24 months
Western Ontario Rotator Cuff Index
次要结局
未报告次要终点