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Not yet recruitingNCT07551089Updated May 26, 2026

Kinematic vs Mechanical Alignment in High Tibial Osteotomy

An interventional study of high tibial osteotomy in Osteo Arthritis of the Knee and Genu Varum, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-05-26.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Osteo Arthritis of the Knee
  • Genu Varum

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03

In context

Genu Varum

18 studies on the registry are indexed under Genu Varum; 8 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 12 interventional studies indexed under Genu Varum.

Browse Genu Varum studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    group 1 (mechanical alignment)

    Procedure: high tibial osteotomy

  • Other
    group 2 (kinematic alignment)

    Procedure: high tibial osteotomy

Interventions

  • Procedurehigh 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

06

What researchers measure

Primary outcomes

  1. oxford knee score

    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.

    Time frame: 12 months

Secondary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 12 months

  2. University of California Los Angeles (UCLA) Activity Score

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07551089
Lead sponsor
Assiut University
Responsible party
Safwat Ahmed (resident doctor, Assiut University) — Principal investigator
First posted
Apr 24, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Jan 1, 2029 (estimated)
Completion
Oct 1, 2029 (estimated)
Last update
May 26, 2026

Study contacts

safwat ahmed safwat, resident doctor
Contact
safwatahmed46@gmail.com
+201098444007

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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