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

NCT06590818 | Recruiting DMC

• 1 other identifier: Ahmed Ramadan Hammad
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Osteo Arthritis Knee; Varus Knee

Outcome Measures

Primary Outcomes (1)

• Blood Loss (defined as blood loss ≥500 cc)

  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

Secondary Outcomes (2)

• Knee Joint Function

  Two hours after the operation

• Assessment of Pain

  Two hours after the operation

Study Arms (1)

varus knee osteoarthritis Group

EXPERIMENTAL

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

Procedure: High tibial osteotomy (HTO

Interventions

High tibial osteotomy (HTO 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

Also known as: Effect of body mass index (BMI)

varus knee osteoarthritis Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 ).

Sponsors & Collaborators

• Egymedicalpedia: lead
• Al-Azhar University: collaborator

Study Sites (1)

Al-Azhar University hospitals

Asyut, Egypt

RECRUITING

Study Officials

• Maysara Abdelhaleem Bayuomy, Assist.Prof

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

  STUDY CHAIR

Central Study Contacts

Ahmed Ramadan Hammad, MSC

CONTACT

01141249007; addamobil852@gmail.com

Gaber Eid Abd-eltawab, Lecturer

CONTACT

+201000504331; Gabereid84.ortho@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: September 19, 2024
• Study Start: July 10, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 10, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-07

Locations

EG (1)