The Effect of Body Mass Index on Short-term Results of HTO

NCT ID: NCT06590818

Last Updated: 2024-09-19

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

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-10

Study Completion Date

2025-07-10

Brief Summary

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The knee joint plays a major role in weight transmission of the body in day-to-day activities. The biomechanics of the knee and malalignment in lower limb anatomy are major risk factors for chronic knee pain, leaving Total Knee Arthroplasty (TKA) as the best and most successful option for patients with end-stage osteoarthritis (OA)

Detailed Description

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Osteoarthritis is a degenerative disease characterized by progressive joint damage.The knee is one of the joints most affected by this pathology, and it is estimated that 10% of men and 13% of women older than 60 years present it.It is characterized by pain, functional limitation, and reduction of quality of life.

Knee osteoarthritis (KOA) is a multi-etiological, chronic disabling disease that affects the entire knee joint, which is the most common site of involvement in OA. KOA is classified as primary or secondary depending on etiology. The pathogenesis of primary KOA is complex and involves numerous factors, such as mechanical stress, inflammation, metabolism, immunity and genetics, with age, genetics, body weight, sex and race being risk factors.

Diagnosis of knee osteoarthritis can be confirmed based on clinical and/or radiological features. The potential of a progressive disease can be prevented or decreased by earlier recognition and correction of associated factors.Obesity and alignment especially varus malalignment are recognized factors of a progressive disease. Both non pharmalogical as well as pharmacological modalities of treatment are useful in managing the symptoms of knee osteoarthritis. Surgery should be considered only in patients who do not respond to medical therapy.

Varus knee osteoarthritis is one of the most common knee diseases in clinical practice. Knee pain and limited range of motion seriously affect the patient's quality of life. However, there is need for further exploration into the prevention and treatment of postoperative complications following artificial joint replacement.

Osteotomy techniques such as high tibial osteotomy are primarily used for the treatment of KOA with varus and valgus deformities.

High body mass index is a risk factor for KOA. A previous study reported a 35% increase in KOA risk with every 5-unit increase in body mass index. This is primarily attributed to the fact that greater body weight increases the weight-bearing pressure of the knee joint, thereby increasing the probability of KOA

Conditions

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Osteo Arthritis Knee Varus Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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varus knee osteoarthritis Group

About 50 patients had varus knee osteoarthritis underwent high tibial osteotomy (HTO)

Group Type EXPERIMENTAL

High tibial osteotomy (HTO

Intervention Type PROCEDURE

To investigate the effect of body mass index (BMI) on the early efficacy of high tibial osteotomy (HTO) in the treatment of varus knee osteoarthritis

Interventions

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High tibial osteotomy (HTO

To investigate the effect of body mass index (BMI) on the early efficacy of high tibial osteotomy (HTO) in the treatment of varus knee osteoarthritis

Intervention Type PROCEDURE

Other Intervention Names

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Effect of body mass index (BMI)

Eligibility Criteria

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Inclusion Criteria

* Meet the diagnostic criteria for knee osteoarthritis and only have one knee
* No serious underlying medical disease
* Conservative treatment is ineffective and there is a willingness for surgery
* X-ray shows degeneration limited to the medial joint space (Ahlback grade ≥ grade II)
* Knee flexion range of motion \> 90°, varus deformity \< 15°, flexion contracture \< 5°.
* Clinical examination shows intact anterior cruciate ligament and collateral ligament, tenderness point is limited to the medial joint space, and the lateral compartment and patellofemoral joint are intact.

Exclusion Criteria

* knee osteoarthritis caused by infection, blood-related or autoimmune diseases.
* severe obesity (BMI\>35 kg/m 2 ) or morbid obesity (obesity caused by diseases such as hypercortisolism and hypothyroidism, BMI≥30 kg/m 2 ).
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role collaborator

Egymedicalpedia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maysara Abdelhaleem Bayuomy, Assist.Prof

Role: STUDY_CHAIR

Orthopedic &Trauma surgery Department, Faculty of medicine, Al-Azhar University, Assiut

Locations

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Al-Azhar University hospitals

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Ramadan Hammad, MSC

Role: CONTACT

01141249007

Gaber Eid Abd-eltawab, Lecturer

Role: CONTACT

+201000504331

Facility Contacts

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Ahmed Ramadan Hammad, MSc

Role: primary

01141249007

Maysara Abdelhaleem Bayuomy, Assist.Prof.

Role: backup

+201063119673

Other Identifiers

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Ahmed Ramadan Hammad

Identifier Type: -

Identifier Source: org_study_id

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