Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty - a Prospective Randomized Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 109
- 试验地点
- 8
- 主要终点
- Assessing total knee implant positioning using PSPG compared with the conventional method in TKR
研究概览
简要总结
A Prospective, randomized, clinical controlled study comparing conventional knee arthroplasty and the Patient-specific positioning guides (PSPG) (Signature Patient Care, Materialise) using the Vanguard Total Knee System (Biomet)
详细描述
Background: Use of PSPG in TKR is a relative new technique and already widely used. PSPG, based on MRI data, fit directly into the patient's anatomy and enable total knee replacement without use of traditional invasive instrumentation. Data showing extra benefit of this technique compared to conventional TKR technique are not widely available.
Aim: To determine the safety of this new surgical technique compared to conventional TKR and whether a clinical, functional and financial benefit can be achieved.
Methods: 200 patients with primary osteoarthritis will be randomized to 2 groups. 30 patients in each group will be included in the RSA section of the study. Participating hospitals UOS Ullevål, Vestre Viken, Sykehuset Telemark and Betanien Hospital Skien. Inclusion started Aug. 2011. Clinical scoring: KSS, KOOS, EQ-5D and VAS will be examined at inclusion, after 3 months, and at the 1 and 2 year control. RSA before discharge on day 2, 3 months, 1 year, 2 years. RSA images will be sent blinded to CIRRO (Center for Implant and Radiostereometric Research Oslo Orthopaedic Centre, Oslo University Hospital) for image analysis. Standing HKA: preoperatively and after 3 months. X-ray will be taken pre-operatively, postoperative day 3, after 3 months and after 5 and 10 years. CT Perth after 3 months for measuring alignment. A cost-benefit analysis will be performed.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man and women elder than 18 years old with knee osteoarthritis
- •Informed consent
排除标准
- •Active infection.
- •Under 50 years.
- •Revision arthroplasty.
- •Marked bone loss which could preclude adequate fixation of the device.
- •Non-cooperative subjects.
- •Parkinson's Disease or other neurologic and muscular disorders
- •Severe vascular insufficiency of the affected limb.
- •Severe instability or deformity of the ligaments and / or surrounding soft tissue which may preclude stability of the device.
- •Paget's disease
- •Rheumatoid Arthritis and other systemic diseases
- •Patients with rigid hip joints
- •Known metal allergy
- •Patients can only join the study with 1 operated knee arthroplasty
结局指标
主要结局
Assessing total knee implant positioning using PSPG compared with the conventional method in TKR
时间窗: 3 months
Measurement of knee implant positioning by using the CT Perth protocol
次要结局
- Clinical Functional Result(2 yrs)
- Operating Time(1 day)
- Component Stability(2 yrs)
- Cost to Benefit from a Health Economic Perspective(1 year)
- X-ray analysis(10 yrs)
- Perioperative Morbidity(1 week)
研究者
Stephan M Rohrl
Principal Investigator
Oslo University Hospital