Kinematic vs Mechanical Alignment in High Tibial Osteotomy

NCT07551089 | Not Yet Recruiting

• 1 other identifier: High Tibial Osteotomy
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osteo Arthritis of the Knee; Genu Varum

Outcome Measures

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.

  12 months

Secondary Outcomes (2)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  12 months

• University of California Los Angeles (UCLA) Activity Score

  12 months

Study Arms (2)

group 1 (mechanical alignment)

OTHER

Procedure: high tibial osteotomy

group 2 (kinematic alignment)

OTHER

Procedure: high tibial osteotomy

Interventions

high tibial osteotomy PROCEDURE

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

group 1 (mechanical alignment); group 2 (kinematic alignment)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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°.
• Gait testing: Able to walk unaided (or with standard aid) for instrumented gait analysis.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Genu Varum

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

safwat ahmed safwat, resident doctor

CONTACT

+201098444007; safwatahmed46@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: April 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04