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

NCT06135454 | Not Yet Recruiting

• 1 other identifier: Knee Osteoarthritis
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

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

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

  Preoperative , three months postoperative , one year postoperative

Study Arms (2)

Open Wedge High Tibial Osteotomy

EXPERIMENTAL

Procedure: Open Wedge High Tibial Osteotomy

Double Level Osteotomy

EXPERIMENTAL

Procedure: Open Wedge High Tibial Osteotomy; Procedure: Double Level Osteotomy

Interventions

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; Open Wedge High Tibial Osteotomy

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.

Double Level Osteotomy

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Akamatsu Y, Nejima S, Tsuji M, Kobayashi H, Muramatsu S. Joint line obliquity was maintained after double-level osteotomy, but was increased after open-wedge high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2022 Feb;30(2):688-697. doi: 10.1007/s00167-020-06430-6. Epub 2021 Jan 12.

  PMID: 33433634 BACKGROUND

• Babis GC, An KN, Chao EY, Rand JA, Sim FH. Double level osteotomy of the knee: a method to retain joint-line obliquity. Clinical results. J Bone Joint Surg Am. 2002 Aug;84(8):1380-8. doi: 10.2106/00004623-200208000-00013.

  PMID: 12177268 BACKGROUND

• Schuster P, Rathgeb F, Mayer P, Michalski S, Hielscher L, Buchholz J, Kruger L, Richter J. Double level osteotomy for medial osteoarthritis and bifocal varus malalignment has excellent short-term results while maintaining physiologic radiographic joint parameters. Knee Surg Sports Traumatol Arthrosc. 2023 Aug;31(8):3124-3132. doi: 10.1007/s00167-022-07247-1. Epub 2022 Dec 10.

  PMID: 36494478 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Abd Elgawad Mohamed Abd Elgawad, Resident

CONTACT

00201003272019; abdelgawadmohamed@med.aun.edu.eg

Mohamed Kamal Abd Elnasser, Assistant professor

CONTACT

00201002438664; Obdelnusser.m.l@aun.edu.eg

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: November 13, 2023
• First Posted: November 18, 2023
• Study Start: December 10, 2024
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share