Clinical trial NCT06135454: Comparison of Outcomes Between Open Wedge High Tibial Osteotomy and Double Level Osteotomy in Antromedial Knee Arthritis With Extra Articular Deformity
Official title: Open Wedge High Tibial Osteotomy Versus Double Level Osteotomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of joint line obliquity (JLO) in the two groups.
timeFrame: Preoperative , three months postoperative , one year postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.