Arthroscopic Evaluation of Cartilage Regeneration After Opening-wedge High Tibial Osteotomy

Osteo Arthritis Knee Clinical Trial

Official title:

Second-look Arthroscopic Evaluation of Cartilage Regeneration After Medial Opening-wedge High Tibial Osteotomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04541342
• Other study ID #: arthroscopy with HTO
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: May 2022

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: Ahmed Mohamed, Bachelor
• Phone: +201064986480
• Email: am.sayed.94[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: May 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• initial arthroscopy with medial opening-wedge high tibial osteotomy fixed by a plate system then second look arthroscopy with plate removal
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.Many of the patients complains of irritation through the plate and wish metal removal after healing of the osteotomy.All patients will undergo initial arthroscopy before high tibial osteotomy (HTO). During arthroscopy, debridement of the degenerate tissues and meniscal tears if present will be performed. Then opening-wedge high tibial osteotomy (OWHTO) will be performed and fixed by a plate system. Second-look arthroscopy will be conducted at the time of plate removal after healing of the osteotomy. This will be after about 6 months up to one year.

Locations

Country	Name	City	State
Egypt	Assiut University Hospitals	Assiut
Egypt	AssiutU Hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arthroscopic assessment of cartilage regeneration after high tibial osteotomy	By use of Outerbridge classification of chondral lesions during arthroscopy, comparison will be made between cartilage status before and after high tibial osteotomy according to the Outerbrigde classification which classifies cartilage lesions into grades of 0 through IV. Grade 0 signifies normal cartilage.; Grade I chondral lesions are characterized by softening and swelling, which often require tactile feedback with a probe or other instrument to assess. Grade II lesion describes a partial-thickness defect with fissures that do not exceed 0.5 inches in diameter or reach subchondral bone.; Grade III is fissuring of the cartilage with a diameter > 0.5 inches with an area reaching subchondral bone.; The most severe is Grade IV, which includes erosion of the articular cartilage that exposes subchondral bone.	6 months after high tibial osteotomy
Secondary	Post-operative limb alignment	by use of bilateral standing anteroposterior full-length views of both lower limbs before high tibial osteotomy and at time of plate removal. The tibiofemoral angle will be measured to detect the degree of varus correction.	6 months after high tibial osteotomy