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

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06135454
• Collaborator: (none)
• Enrollment: 44
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Procedure: Open Wedge High Tibial Osteotomy; Procedure: Double Level Osteotomy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open Wedge High Tibial Osteotomy Versus Double Level Osteotomy
• Anticipated Study Start Date: Dec 10, 2023
• Anticipated Primary Completion Date: Oct 10, 2025
• Anticipated Study Completion Date: Dec 10, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Open Wedge High Tibial Osteotomy	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 .
Experimental: Double Level Osteotomy	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.

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Abd Elgawad Mohamed Abd Elgawad Ahmed, Resident Doctor, Assiut University
• ClinicalTrials.gov Identifier: NCT06135454
• Other Study ID Numbers: Knee Osteoarthritis
• First Posted: Nov 18, 2023
• Last Update Posted: Nov 21, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Nov 21, 2023