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临床试验/NCT07551089
NCT07551089尚未招募不适用

The Short Term Outcome of Kinematic Versus Mechanichal Alignment After High Tibial Osteotomy for Varus Osteoarthritic Knee : A Prospective Randomized Controlled Trial

Assiut University0 个研究点目标入组 100 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
oxford knee score

研究概览

简要总结

To compare between kinematic and mechanichal alignment after High Tibial Osteotomy (clinically and radiologically)

详细描述

High tibial osteotomy (HTO) is a well-established joint-preserving procedure for younger and active patients with medial compartment osteoarthritis associated with varus malalignment. By laterally shifting the mechanical axis of the lower limb, HTO unloads the diseased medial compartment, alleviates pain, and delays the need for knee arthroplasty.

Traditionally, HTO planning has relied on a Mechanical alignment strategy, aiming to shift the weight-bearing line toward the lateral compartment. Fujisawa et al. described targeting a point located at approximately 62-65% of the tibial plateau width, which has been shown to optimize medial compartment unloading and improve long-term survivorship following HTO.

However, mechanical alignment applies a uniform correction target without accounting for individual anatomical variability. This is commonly achieved by correcting varus alignment to a slight valgus position (approximately 3-5°) through increasing the medial proximal tibial angle (MPTA). Such standardized correction may result in overcorrection, increased joint-line obliquity, altered soft-tissue balance, and excessive loading of the lateral compartment. These biomechanical changes may accelerate lateral cartilage degeneration and contribute to postoperative complications, potentially compromising long-term outcomes.

In contrast, Kinematic alignment (KA) is based on restoring the patient's native anatomical alignment and physiological joint-line orientation, rather than forcing all patients toward a fixed valgus target. By correcting only the pathological varus deformity and restoring the MPTA toward physiological values without overcorrection, kinematic alignment aims to preserve normal knee biomechanics and balanced soft-tissue tension.

Accordingly, the present study aims to make HTO not a temporary relief evaluate whether a kinematic alignment strategy in HTO can achieve comparable or superior clinical and radiological outcomes compared with mechanical alignment, while potentially reducing complications and delaying the need for total knee replacement.

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

性别
All
接受健康志愿者

入选标准

  • Clinical:
  • Age : Adult with symptomatic osteoarthritic varus knee 2-Medial knee pain with functional limitation ≥6 months despite optimized non-operative care.
  • Radiological: 1- Medial compartment OA in Xray AP-Lateral view 2-Degree of varus ≥3 and ≤15 degree in long film(full-length, standing hip-to-ankle radiographs) 3-•Varus knee (mpta ≤85 degree and ldfa ≤93 and jlca ≤5)
  • Physical : 1-Range of motion: Flexion ≥110°, flexion contracture ≤10°, extension lag ≤5°.
  • 2-Gait testing: Able to walk unaided (or with standard aid) for instrumented gait analysis.

排除标准

  • 1- Predominantly lateral compartment OA 2- severe patellofemoral arthritis 3- Prior high tibial osteotomy, knee arthroplasty, or complex fracture around the knee 4-Inflammatory arthropathies (eg, rheumatoid arthritis) 5- end stage medial compartment osteoarthritis with bone erosions 6-chondrocalcinosis

研究组 & 干预措施

group 1 (mechanical alignment)

Other

干预措施: high tibial osteotomy (Procedure)

group 2 (kinematic alignment)

Other

干预措施: high tibial osteotomy (Procedure)

结局指标

主要结局

oxford knee score

时间窗: 12 months

a validated, patient-reported outcome measure specifically designed for knee pathology. The OKS is a short, patient-centred questionnaire that assesses both pain and functional ability from the patient's perspective. It is widely recognized for its simplicity, reliability, and sensitivity to clinically meaningful changes following knee surgery. By adopting a PROM as the main clinical outcome, this study emphasizes patient-relevant benefit rather than relying solely on radiographic or surrogate measures. The OKS will be assessed preoperatively and at scheduled postoperative follow-up intervals, with the 12-month endpoint defined as the primary time point.

次要结局

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)(12 months)
  • University of California Los Angeles (UCLA) Activity Score(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Safwat Ahmed

resident doctor

Assiut University

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