The Effect of Body Mass Index on Short-term Results of HTO
The Effect of Body Mass Index on Short-term Results of HTO for Treatment of OA With Varus Knee in Upper Egypt Population
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Asyut, Egypt
- Al-Azhar University hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 ).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: varus knee osteoarthritis Group
About 50 patients had varus knee osteoarthritis underwent high tibial osteotomy (HTO)
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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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Blood Loss (defined as blood loss ≥500 cc)
Time Frame: First 2 hours till 3 days after the operation
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Assessment of bleeding intraoperative and post operative by measuring Hemoglobin level and Hematocrit level pre and post operation.
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First 2 hours till 3 days after the operation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Knee Joint Function
Time Frame: Two hours after the operation
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Evaluated using HSS score, knee range of motion before and after the operation.
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Two hours after the operation
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Assessment of Pain
Time Frame: Two hours after the operation
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Assessment of Pain by using VAS score for pain status
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Two hours after the operation
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Maysara Abdelhaleem Bayuomy, Assist.Prof, Orthopedic &Trauma surgery Department, Faculty of medicine, Al-Azhar University, Assiut
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Ahmed Ramadan Hammad
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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