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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

Open Wedge High Tibial Osteotomy Versus Double Level Osteotomy

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06135454
Enrollment
44
Registered
2023-11-18
Start date
2024-12-10
Completion date
2026-12-10
Last updated
2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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).

Interventions

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 .

PROCEDUREDouble 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

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Contacts

Primary ContactAbd Elgawad Mohamed Abd Elgawad, Resident
abdelgawadmohamed@med.aun.edu.eg00201003272019
Backup ContactMohamed Kamal Abd Elnasser, Assistant professor
Obdelnusser.m.l@aun.edu.eg00201002438664

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026