Finding the Optimal Aim of Correction in Opening Wedge High Tibial Osteotomy Using 3D Printed Patient-specific Instrumentation (PSI). An RCT Comparing Correction Aimed at 62% Versus 55%.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- Knee injury and Osteoarthritis Outcome Score subscore Quality of Life (KOOS QOL), 0-100, 100 best score
研究概览
简要总结
The purpose of this RCT is to investigate whether high tibial osteotomy using 3D printed patient specific guides aiming at 55% correction is non-inferior to aiming at 62%.
详细描述
HTO should play a major role in modern treatment algorithms for knee overload and osteoarthritis. By transferring load from the failing/osteoarthritic compartment of the knee to a healthier compartment, HTO can delay or stop the progression of osteoarthritis at an early stage. This can remove pain and increase knee function, making return to work, activities and sport possible. HTO may delay or avoid the need for total knee replacement for >10 years for at least 80% of patients.
The optimal target for the postoperative mechanical axis of the leg is not yet clarified. Both under- and overcorrection can lead to unfavourable results. The classical Fusjisawa´s point of 62%, or approximately 3 deg. of valgus, is still often used as the optimal target, and studies show good clinical results and longevity. With an often accepted accuracy of +/- 3 deg. with conventional methods, the accepted postoperative range of valgus will be from 0 deg. to 6 deg. But the optimal range is possibly much narrower. Recent studies suggest a narrower range and less overcorrection.
3D-printed patient specific instrumentation (PSI) is based on CT of the individual patient´s knee, data simulation of the planned correction and subsequent 3D printed guides for each patient. The PSI design varies, but involves a positioning guide fitting only in position one the proximal tibia, a cutting guidance and a wedge opening guide. PSI seem to improve accuracy to the level of approximately +/- 1 deg. from the preplanned correction and leads to fewer unacceptable outliers compared to the conventional methods available. Improved accuracy has not shown to yield better clinical results.
In the future the target axis should possibly be individualized, based on the pathology treated, gait analyses and data simulations.
Modern gait analysis using wearable accelerator sensors, often referred to as inertial measurement units (IMUs) is rapidly evolving. By coupling individualized and accurate osteotomy with gait analysis using wearable sensors, one could better predict and understand how to normalise each individual patients´ gait pattern and possibly improve patient satisfaction and function after surgery.
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)
盲法说明
Participants blinded. Care provider/surgeon not possible to mask. Investigator masked. Outcome assessor masked/blinded data set.
入排标准
- 年龄范围
- 20 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having accepted and signed the informed consent form before surgery
- •Patients aged 30-60 years
- •Patients with an indication for primary HTO based on anamnestic, clinical and radiological findings leading to the diagnosis of major medial knee compartment overload symptoms
- •Mechanical varus axis of 3-9 deg. (calculated on full length weightbearing X-ray (FLWB))
- •Correctable angular deformity on the tibia only (medial proximal tibial angle (MPTA) + planned correction < 95 deg. Lateral distal femoral angle (LDFA) <92 deg.)
- •Maximal calculated gap height 14 mm
- •Only the first knee will be included if later contralateral HTO
排除标准
- •Inflammatory arthritis (Rheumatoid Arthritis, Bechterew arthritis, Psoriatic Arthritis)
- •Patients using Prednisolone perorally
- •Smokers (need to quit preoperatively)
- •Significant overweight (Body Mass Index > 35)
- •Earlier fractures in affected leg with fracture malalignment >5 deg.
- •Extension deficit >10 deg. in the affected knee
- •Earlier septic arthritis/osteomyelitis in the affected leg
- •Previous major surgery affecting leg function. Earlier knee arthroscopic procedures like ACL-reconstruction are not excluded
- •Planned combined procedures involving HTO + ACL/PCL-reconstruction, meniscal transplantation or meniscal root fixation is excluded
- •Neurologic disease with symptoms affecting the leg
- •Serious illness or other factors that make communication, follow-up or rehabilitation difficult (e.g. alcohol or drug abuse, psychiatric disease, non-Norwegian speakers).
结局指标
主要结局
Knee injury and Osteoarthritis Outcome Score subscore Quality of Life (KOOS QOL), 0-100, 100 best score
时间窗: 24 months
Knee related Quality of Life
次要结局
- University of California at Los Angeles activity level (UCLA), 0-10, 10 most active(24 months)
- Ground contact time (milliseconds)(24 months)
- EuroQol-5D (EQ-5D), index 0-1, 1 best score(24 months)
- Knee injury and Osteoarthritis Outcome Score 12 Short form (KOOS-12), 0-100, 100 best score(24 months)
- Forgotten Joint Score-12(FJS-12), 0-100, 100 best score(24 months)
