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Comparison of Outcomes Between Open Wedge High Tibial Osteotomy and Double Level Osteotomy in Antromedial Knee Arthritis With Extra Articular Deformity

NCT06135454 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-02-15

No results posted yet for this study

Summary

To compare the radiographic and clinical outcomes of varus osteoarthritic knees treated with an open-wedge high tibial osteotomy (OWHTO) alone or with a double-level osteotomy (DLO). It was hypothesized that treatment with DLO would prevent the joint line obliquity (JLO) , optimize post-operative limb alignment and provide better clinical and radiological outcomes after surgery than medial opening-wedge high tibial osteotomy (OWHTO) alone for patients with medial compartment osteoarthritis.

Conditions

Interventions

PROCEDURE

Open Wedge High Tibial Osteotomy

For OWHTO,The osteotomy plane, directed from 30 to 35 mm distal to the medial tibial plateau to 10-15 mm distal to the lateral tibial plateau in the coronal plane, was marked by two Kirschner wires with threaded tips. A transverse osteotomy was performed, leaving the lateral cortex intact as a hinge. After the ascending osteotomy and opening. The medial opening gap was filled with two β-TCP wedges and fixed with a TomoFix anatomical plate and locking screws .

PROCEDURE

Double Level Osteotomy

The DLO was started from a lateral DFO. A 5-6-cm incision was made proximally at the distal femur from the lateral femoral epicondyle.Two Kirschner wires with threaded tips were inserted to make a length between the wires that was preoperatively planned as the lateral closed osteotomy. Transverse and ascending osteotomies were performed using a Precision Oscillating Tip Saw. The gap was closed and fixed using a TomoFix medial distal femur anatomical plate , which was bent for the lateral distal femur. The subsequent OWHTO was performed as described above.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2026-10-10
Completion
2026-12-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06135454 on ClinicalTrials.gov