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Not yet recruiting NCT07551089

Kinematic vs Mechanical Alignment in High Tibial Osteotomy

No phase Interventional Osteo Arthritis of the Knee Genu Varum

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: high tibial osteotomy.
Who it may be relevant to
Registry conditions: Osteo Arthritis of the Knee, Genu Varum. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Detailed description

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.

Interventions

  • Procedure high tibial osteotomy
    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

Primary outcome measures

  • oxford knee score [Time frame: 12 months]
Secondary outcome measures (2)
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: 12 months]
  • University of California Los Angeles (UCLA) Activity Score [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Clinical: 1. 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07551089 · High Tibial Osteotomy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗