Do Patient Specific Implants Improve Accuracy of Correction With MOWHTO. A Pilot Study for a Definitive Randomised Trial Comparing TOMOFIX and BodyCAD Fine Osteotomy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- KOOS
研究概览
简要总结
This is a single centre, randomised, patient blinded pilot study that will assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge high tibial osteotomy (MOWHTO) to either current standard of care with TOMOFIX plating system, or utilise patient specific instrumentation and custom-made plate development, with BodyCAD Fine Osteotomy. If the definitive study is deemed feasible, an additional 110 participants will be randomized, for a total of 150 participants.
详细描述
The proposed study is a single centre, pilot randomised controlled, patient blinded study that will randomly assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge proximal tibial osteotomy (MOWHTO) to either current standard of care, with TOMOFIX plating system, or utilise patient specific instrumentation and custom-made plate development, with BodyCAD Fine Osteotomy. Participants will follow a standardized rehabilitation protocol. Outcomes will be assessed over two years postoperatively utilising CT assessment for accuracy of correction, bony union and construct stability as well as PROMs including KOOS and EQ5D.
Complications, adverse events, returns to theatre and costs will also be recorded. End of study is defined when the last enrolled subject reaches the 24-month follow-up time point and close-out activities are complete.
If the pilot study demonstrates the feasibility of the definitive trial, an additional 110 participants will be ennrolled, for a total of 150 participants.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-70 years old
- •have medial compartment osteoarthritis, with varus alignment, deemed suitable for a MOWHTO
- •able to speak, read and understand English
排除标准
- •found to have a cruciate ligament deficiency
- •require multiplanar or rotational alignment correction
- •have greater than 5 degrees fixed flexion deformity
- •unable to have CT scans for follow up
- •evidence of tricompartmental osteoarthritis
- •evidence of lateral compartment osteoarthritis on arthroscopy
- •received injection therapy within 3 months of surgery on the operative knee
- •have a medical history of inflammatory arthropathy, diabetes
- •actively smoke
结局指标
主要结局
KOOS
时间窗: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
The KOOS is a 42-item knee-specific questionnaire with five separately reported domains, including pain, other symptoms, function in daily living, function in sports/recreation and knee-related quality of life. Domain scores represent the average of all items in the domain standardized to a score from 0 to 100 (worst to best). This instrument has demonstrated construct validity, excellent test-retest reliability for each domain (range, 0.75 to 0.93) and is responsive to change.
次要结局
- EQ-5D (Index and VAS)(Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months)
- Cost Effectiveness(Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months)
- Procedure Time(Surgery)
- Adverse Events(Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months)
研究者
Al Getgood
Principal Investigator
Western University, Canada