Patient Specific Instrumentation (PSI) Referencing Osteotomy Technological Transfer and Education - a PSI High Tibial Osteotomy, Double-blinded, Randomized Controlled Trial - the PROTECTED HTO (High Tibial Osteotomy) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain Visual Analog Scale (VAS) score
研究概览
简要总结
Medial open wedge high tibial osteotomy is a surgery performed to treat knee osteoarthritis in young patients.Recently with our department advance of technology, the investigators performed computed tomography for the patient's lower limb and 3D reconstruct the image. Based on the 3D image, the investigators planned our planned osteotomy cut on computer software Materialize 3 and the investigators then 3D printed a metal jig that has a slot to produce the osteotomy and also protected the neurovascular bundles. Therefore these metal jigs are specific to each patients. The investigators have performed a few cases of HTO under this extra metal jig protection and guidance and noted it has improved accuracy and safety clinically. However, whether it has scientific significance difference in accuracy is not known.
详细描述
Medial open wedge high tibial osteotomy is a surgery performed to treat knee osteoarthritis in young patients. Currently the investigators perform high tibial osteotomy under the guidance of computer navigation to achieve the required alignment. During conventional high tibial osteotomy the bone cut is done by free hand cutting, there are risks of cutting into the posterior proximal tibia compartment and transect the neurovascular bundles which is a surgical disaster and may then lead to loss of limb. And the accuracy of free hand cutting is limited by experience of surgeons. In our conventional high tibial osteotomy transection of neurovascular bundles has never happened given our meticulous surgical technique but the investigators believe an extra protection is always beneficial to our patients. Recently with our department advance of technology, the investigators performed computed tomography for the patient's lower limb and 3D reconstruct the image. Based on the 3D image, the investigators planned our planned osteotomy cut on computer software Materialize 3 and the investigators then 3D printed a metal jig that has a slot to produce the osteotomy and also protected the neurovascular bundles. Therefore these metal jigs are specific to each patients. The investigators have performed a few cases of HTO under this extra metal jig protection and guidance and noted it has improved accuracy and safety clinically. However, whether it has scientific significance difference in accuracy is not known.
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)
盲法说明
Randomization will be accomplished by computer-generated randomization sequence using serially numbered opaque, sealed envelopes with patients assigned either to intervention or control groups. All investigators, research staff, patients except the surgeon performing the HTO will be blinded to the group assignment of the subjects. Nor they will be aware of the regimen prescribed during the study and evaluation periods. A randomization code will be allocated to each included subjects to maintain blindness. Randomization code will be broken only after the database had been locked. Patient rehabilitation, post-operative assessment and Data analysis are conducted by personnel blinded to the patients' randomization assignment.
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
- •symptomatic patient with medial compartment knee OA
- •medial compartment OA was grade 3 or milder according to Kellgren-Lawrence classification
排除标准
- •lateral compartment OA
- •symptomatic patellofemoral compartment OA,
- •inflammatory arthritis,
- •significant loss of knee joint range in flexion (less than 100°) or in extension (less than - 10°),
- •ligamentous instability,
- •obesity with a body mass index greater than 30,
- •significant psychological disorder
- •inability to communicate in Chinese or English language
结局指标
主要结局
Pain Visual Analog Scale (VAS) score
时间窗: 2 year post-op
The VAS is a psychometric response scale and a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The VAS pain ranges 0-10, with 10 representing the most pain.
Measurement of knee displacement
时间窗: 1 year after surgery
Measure the displacement (in cm) between femoral head and tibial head on a secured computer using CT scan images and scanogram images
Knee Society knee score
时间窗: 2 year post-op
Clinical and functional scores, on a 100-point scale; Knee Society score (KSS) has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. "Excellent" for score 80-100, "Good" for score 70-79, "Fair" for score 60-69, "Poor" for score below 60.
Knee Society function score
时间窗: 2 year post-op
Clinical and functional scores, on a 100-point scale; Knee Society score (KSS) has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. "Excellent" for score 80-100, "Good" for score 70-79, "Fair" for score 60-69, "Poor" for score below 60.
Oxford Knee Score
时间窗: 2 year post-op
Clinical and functional scores
Range of motion
时间窗: 2 year post-op
Evaluated using a manual goniometer
次要结局
未报告次要终点
研究者
Lawrence CM Lau
Principle Investigator
Chinese University of Hong Kong