Meniscal Repair: A Randomized Prospective Trial of FAST-FIX vs. Meniscal Suturing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Quality of life at 2 years as measured by The Western Ontario Meniscal Evaluation Tool (WOMET)
研究概览
简要总结
Meniscal repair resulting in meniscal preservation is the most desirable treatment of a torn meniscus and is one of the most commonly performed arthroscopic procedures. The inside-out meniscal suturing technique allows precise placement of sutures under direct visualization and studies have reported excellent healing rates and low re-tear rates. However, complications associated with the use of the inside-out technique (injury to the knee's neurovascular structures and infection) and the fact that it is a time consuming procedure have generated the development of alternative methods and devices. The FasT-Fix is reported to be quicker and safer. It is applicable to tears in most locations and requires no additional incisions or portals. Even though this and many similar devices are widely used with reported clinical healing rates of 75 -92% and relatively minor complications, few prospective, randomized clinical trials evaluating and comparing different techniques have been carried out. Patient outcome studies are necessary to evaluate which technique ultimately results in the most effective repair and the least patient disability following surgery.
We hypothesize that an inside-out suturing technique will have a higher complication rate but a significantly lower failure rate than the FasT-Fix Menisical Repair System
详细描述
In this prospective, randomized, trial subjects will be randomly assigned to the inside-out group or the FasT-Fix group and will be followed for at least 24 months. Primary outcome is the difference between groups in the disease specific quality of life assessment - The Western Ontario Meniscal Evaluation Tool. Secondary outcome measures include range of motion, functional outcome scores, surgical time, complication rate, meniscal retear and differences between groups in post-operative pain. The data collector will be blinded to patients' intervention group. Secondary outcome measures include range of motion, functional outcome scores, disease-specific quality of life outcome scores and the standard knee clinical examination.
Study Population: The investigators will assess all patients presenting with suspected meniscal tears. Those meeting the inclusion/exclusion criteria will be asked to sign an informed consent. Subjects who have successfully been screened and are slated to be randomized into the study must have a pre-operative visit within 12 months of their scheduled surgery.
Routine knee x-rays will be performed on all patients to rule out extensive degenerative changes, loose bodies, fractures, osteochondritis dissecans and other lesions.
Treatment Protocols: Intervention group assignment will take place at the time of surgery, once the patient has undergone the initial arthroscopy and a diagnosis of a repairable meniscal tear has been confirmed. Patients will be stratified for surgeon and for concurrent ACL reconstruction. They will then be randomized to one of the two treatment groups.
Meniscal repair is a day surgery procedure performed under general anaesthesia and tourniquet control as required. Prior to the repair, synovial abrasion and debridement of scar tissue will be carried out to promote vascular ingrowth.
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)
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •** Canadians Only can be recruited for this trial
- •History indicative of meniscal pathology (i.e. pain, locking, clicking or giving way of the knee) +/- ACL insufficiency
- •On physical exam, evidence of a meniscal tear (i.e. a locked joint, joint line tenderness and pain on meniscal compression +/- evidence of an ACL tear
- •Vertical tears in the peripheral 0-5mm of the meniscus that are reducible
排除标准
- •Intraarticular/Extraarticular knee infection
- •Metabolic bone, collagen, crystalline joint or neoplastic disease
- •Previous meniscal repair
- •Meniscal tears that are in the avascular zone
- •Stable meniscal tears, i.e. tears <10mm and displaced < 3mm, partial tears
- •Radial, horizontal or flap tears
- •Unwillingness to comply with the rehabilitation protocol or to be followed for 2 years
- •Inability or unwillingness of subject /legal guardian to give written informed consent
结局指标
主要结局
Quality of life at 2 years as measured by The Western Ontario Meniscal Evaluation Tool (WOMET)
时间窗: 2 years
次要结局
- Differences between groups in post-operative pain(2 years)
- Surgical time(day 0)
- Complication rate(2 years)
- Other physical symptoms such as joint line pain/tenderness, knee effusion(2 years)
- Side-to-side difference in knee joint range of motion(2 years)
- Re-tear rate (as confirmed by MRI or arthroscopy), Functional outcome scores(2 years)