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

NCT04541342 | Completed

• 1 other identifier: arthroscopy with HTO
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post-operative limb alignment

  6 months after high tibial osteotomy

Study Arms (1)

osteoarthritic with genu varus

EXPERIMENTAL

initial arthroscopy and high tibial osteotomy to be followed later by a second look arthroscopy with plate removal

Procedure: initial arthroscopy with medial opening-wedge high tibial osteotomy fixed by a plate system then second look arthroscopy with plate removal

Interventions

initial arthroscopy with medial opening-wedge high tibial osteotomy fixed by a plate system then second look arthroscopy with plate removal PROCEDURE

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.

osteoarthritic with genu varus

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Assiut University Hospitals

Asyut, Egypt

Location

AssiutU Hospitals

Asyut, Egypt

Location

Related Publications (4)

• 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.

  PMID: 28291955 BACKGROUND

• 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.

  PMID: 29533246 BACKGROUND

• 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.

  PMID: 12893144 BACKGROUND

• AbdelKawi AF, El-Assal MA, Abdelhamid MM, Sayed AM. Arthroscopic evidence of improvement in cartilage lesions after medial opening-wedge high-tibial osteotomy with valgus correction and its positive impact on clinical outcomes, a prospective study. Int Orthop. 2025 Aug;49(8):1879-1885. doi: 10.1007/s00264-025-06552-x. Epub 2025 Jun 2.

  PMID: 40455268 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician

Model Details: quasi experimental one group pretest posttest study design

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 9, 2020
• Study Start: September 1, 2020
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

EG (2)