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NCT Number: NCT06135454

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Osteoarthritis is a degenerative joint disease characterized by erosion of the articular cartilage, hypertrophy of the bone at the margins and subchondral sclerosis(1). Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to be varus deformity of the knee(2). High tibial osteotomy (HTO) is a well-established method for treatment of medial Uni compartmental-knee osteoarthritis and correction of varus deformity(3).Double level osteotomy recently used as another method for treatment this problem to improve outcomes and decrease complication(4).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients that are indicated for surgery for medial compartment osteoarthritis only (medial joint line tenderness, varus tibiofemoral malalignment) with classification of Kellgren Lawrence grade (1/2/3)
Age between 40 _ 60 years
No associated bony fractures or deformities
No associated ligamentous functional instability
Varus more than or equal 15 degrees

Exclusion criteria

Age younger than 40 or older than 60 years
Secondary Arthritis (Inflammatory arthritis, post-traumatic osteoarthritis, active knee infection)
Lateral Compartment OA or patellofemoral OA

Treatment and study plan

Open Wedge High Tibial Osteotomy

Procedure

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 .

Double Level Osteotomy

Procedure

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.

Primary outcomes

Occurrence of joint line obliquity (JLO) in the two groups.

Time frame: Preoperative , three months postoperative , one year postoperative

Postoperative limb alignment using bilateral standing anteroposterior full-length views of both lower limbs

Study contacts

Contact information is provided by the study sponsor or research team.

Abd Elgawad Mohamed Abd Elgawad, Resident

CONTACT

[email protected]

00201003272019

Mohamed Kamal Abd Elnasser, Assistant professor

CONTACT

[email protected]

00201002438664

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Open Wedge High Tibial Osteotomy Versus Double Level Osteotomy

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Nov 18, 2023
Registry last updated: Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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