A Randomized, Prospective, Blinded Clinical Trial Comparing Two Total Knee Replacement Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Primary outcome: clinical outcomes in the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups, using the Knee Society Score.
研究概览
简要总结
The purpose of this study is to evaluate and compare the clinical, radiographic (x-ray) and cost effectiveness outcomes (cost relative to risks and benefits) of two different minimally invasive knee joint replacement surgical techniques. The primary study hypothesis is that in comparing total knee replacement performed with the two different surgical techniques that respect four minimally invasive surgery principles (low-profile instrumentation, "minimally invasive" incision, overall minimal knee surgical intervention), a faster return to function will result when the technique does not incise the tendon.
详细描述
This study does not include financial compensation for treatments involved.
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
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of severely symptomatic knee osteoarthritis that has failed non- operative treatment
- •Males and non-pregnant females, 35-85 years of age at the time of surgery
- •ASA class 1 or 2
- •Procedure will not require computer navigation
- •Patient/Surgeon has not requested another implant
- •Patient has signed an IRB approved study consent form
- •Patient is able and willing to actively participate in post-operative rehabilitation program
- •Patient understands study requirements
- •Patient is willing to comply with follow-up visits and diary documentations
- •Patient is capable of independent ambulation
排除标准
- •Skeletal immaturity
- •More than 10 degrees of valgus or varus deformity as measured from a weight bearing AP alignment view
- •Patients with bilateral knee osteoarthritis who are considering a simultaneous bilateral procedure
- •Bone or ligament insufficiency that requires the use of augments or stems, or constrained component
- •Daily pre-operative use of narcotic pain medication
- •Prior knee arthroplasty
- •Patient is a prisoner
- •Patient has had prior tibial tubercle osteotomy
- •Patient's surgical knee would require removal of hardware prior to TKA
- •Patient has < 95 degrees flexion pre-operatively
结局指标
主要结局
Primary outcome: clinical outcomes in the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups, using the Knee Society Score.
时间窗: 5 years
次要结局
- Secondary outcome: Includes cost-effectiveness of the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups; EQ-5D, SF-12; radiographic assessment using Knee Society Radiographic Assessment.(5 years)