Clinical trial NCT04541342: Arthroscopic Evaluation of Cartilage Regeneration After Opening-wedge High Tibial Osteotomy
Official title: Second-look Arthroscopic Evaluation of Cartilage Regeneration After Medial Opening-wedge High Tibial Osteotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 49
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: quasi experimental one group pretest posttest study design
Primary purpose: TREATMENT

Brief summary: Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to by varus deformity of the knee. High tibial osteotomy is a well-established method for treatment of medial unicompartmental knee osteoarthritis and correction of varus deformity.

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. Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to by varus deformity of the knee. High tibial osteotomy is a well-established method for treatment of medial unicompartmental knee osteoarthritis and correction of varus deformity. It is a joint preserving procedure especially preferred in young patients for whom arthroplasty is not desirable. The procedure promotes regeneration by causing lateral shift of the weight-bearing axis, thus decreasing load on the medial compartment and widening the medial joint space. The methods for اigh tibial osteotomy include opening-wedge osteotomy and closed wedge osteotomy. An opening-wedge osteotomy has become increasingly popular compared to the other technique. One of the disadvantages of this technique is that the plate is placed subcutaneously on the medial aspect of the proximal tibia. Many of the patients complains of irritation through the plate and wish metal removal after healing of the osteotomy. Few papers assessed regeneration of the articular cartilage after medial opening-wedge osteotomy.

Eligibility criteria: Inclusion Criteria:

1. Age younger than 65 years
2. Medial joint line tenderness
3. BMI less than 30
4. Varus tibiofemoral malalignment
5. Range of motion in the knee joint maintained from greater than 100 degrees of flexion to less than 15 degrees of flexion contracture
6. Osteoarthritis of the knee with any degree of cartilage damage provided that the cartilage damage in the lateral compartment not exceeding Outerbridge grade 2
7. No associated ligamentous functional instability

Exclusion Criteria:

1. Age older than 65 years
2. Severe Lateral compartment osteoarthritis (Outerbridge grade 3 or 4)
3. Flexion contracture of greater than 15 degrees
4. Inflammatory arthritis, post-traumatic osteoarthritis, active knee infection

Primary outcomes:
measure: Arthroscopic assessment of cartilage regeneration after high tibial osteotomy
timeFrame: 6 months after high tibial osteotomy
Secondary outcomes:
measure: Post-operative limb alignment
timeFrame: 6 months after high tibial osteotomy
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospitals
city: Assiut
country: Egypt
facility: AssiutU Hospitals
Study officials:
References:
citation: Kim KI, Seo MC, Song SJ, Bae DK, Kim DH, Lee SH. Change of Chondral Lesions and Predictive Factors After Medial Open-Wedge High Tibial Osteotomy With a Locked Plate System. Am J Sports Med. 2017 Jun;45(7):1615-1621. doi: 10.1177/0363546517694864. Epub 2017 Mar 14.
citation: Slattery C, Kweon CY. Classifications in Brief: Outerbridge Classification of Chondral Lesions. Clin Orthop Relat Res. 2018 Oct;476(10):2101-2104. doi: 10.1007/s11999.0000000000000255. No abstract available.
citation: Koshino T, Wada S, Ara Y, Saito T. Regeneration of degenerated articular cartilage after high tibial valgus osteotomy for medial compartmental osteoarthritis of the knee. Knee. 2003 Sep;10(3):229-36. doi: 10.1016/s0968-0160(03)00005-x.