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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Asyut, Egypten
- Al-Azhar University hospitals
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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 ).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: varus knee osteoarthritis Group
About 50 patients had varus knee osteoarthritis underwent 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
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood Loss (defined as blood loss ≥500 cc)
Tidsramme: First 2 hours till 3 days after the operation
|
Assessment of bleeding intraoperative and post operative by measuring Hemoglobin level and Hematocrit level pre and post operation.
|
First 2 hours till 3 days after the operation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Knee Joint Function
Tidsramme: Two hours after the operation
|
Evaluated using HSS score, knee range of motion before and after the operation.
|
Two hours after the operation
|
|
Assessment of Pain
Tidsramme: Two hours after the operation
|
Assessment of Pain by using VAS score for pain status
|
Two hours after the operation
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Maysara Abdelhaleem Bayuomy, Assist.Prof, Orthopedic &Trauma surgery Department, Faculty of medicine, Al-Azhar University, Assiut
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Ahmed Ramadan Hammad
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .