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

NCT ID: NCT04541342

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2024-01-31

Brief Summary

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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

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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.

Conditions

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Osteo Arthritis Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

quasi experimental one group pretest posttest study design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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osteoarthritic with genu varus

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Sayed Mohamed

physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University Hospitals

Asyut, , Egypt

Site Status

AssiutU Hospitals

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 28291955 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29533246 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12893144 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40455268 (View on PubMed)

Other Identifiers

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arthroscopy with HTO

Identifier Type: -

Identifier Source: org_study_id

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