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

Not Applicable

Not yet recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: Open Wedge High Tibial Osteotomy; Procedure: Double Level Osteotomy

• Registration Number: NCT06135454
• Lead Sponsor: Assiut University

Brief 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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-13
• Study First Posted: 2023-11-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15
• Study Start: 2024-12-10
• Primary Completion: 2026-10-10
• Study Completion: 2026-12-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double Level Osteotomy	Open Wedge High Tibial Osteotomy	-
Open Wedge High Tibial Osteotomy	Open Wedge High Tibial Osteotomy	-
Double Level Osteotomy	Double Level Osteotomy	-

Primary Outcome Measures

Name	Time	Method
Occurrence of joint line obliquity (JLO) in the two groups.	Preoperative , three months postoperative , one year postoperative	Postoperative limb alignment using bilateral standing anteroposterior full-length views of both lower limbs