Comparing the functional results of Persona's medial congruent and posterior-stabilized prostheses in total knee arthroplasty

Not Applicable

• Conditions: Severe end-stage knee osteoarthritis eligible for TKA surgery.; Osteoarthritis of knee

• Registration Number: IRCT20191222045857N2
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients with severe end-stage osteoarthritis of the knee who are eligible for TKA surgery (painful and disabled knee joint with involvement of one or more compartments)
Patients with osteoarthritis resistant to conservative treatment

Exclusion Criteria

Previous hip or ankle replacement
Rheumatoid Arthritis
Active infections, local or systemic
Osteotomy or previous fracture or surgery of the tibia or femur

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alignment of limbs and prostheses. Timepoint: Patients visit the clinic for evaluation at 2, 6, 12 and 6 months of age and then annually after surgery. Knee radiographs including AP and lateral views will be taken. Method of measurement: A long standing radiograph of the knee leg at 3 months after surgery will be used to evaluate the hip-knee-ankle angle (HKA; mechanical axis) of the lower limb, the varus and/or valgus angle of the femur relative to the mechanical axis of the femur. (medial femoral distal angle; MDFA), and the varus and/or valgus angle of a tibial component relative to the mechanical axis of the tibia (medial proximal tibial angle). A lateral radiograph will be used to assess the flexion of the femoral component (femoral flexion angle) and the tilt of the tibial component (tibial tilt).

Secondary Outcome Measures

Name	Time	Method
Total surgery time. Timepoint: From skin incision to wound closure from arthrotomy site repair, vacuum drain placement and skin closure. Method of measurement: Based on the time measured by the stopwatch.;The total amount of intraoperative bleeding. Timepoint: From skin incision to wound closure from arthrotomy site repair, vacuum drain placement and skin closure. Method of measurement: The amount of blood collected by the suction device.;Hb changes. Timepoint: Before and 24 hours after the operation. Method of measurement: CBC, diff.;Blood transfusion rate. Timepoint: Hospitalization period. Method of measurement: Counting the number of blood units injected.;Improve performance. Timepoint: Weeks 2, 6, 12 and 6 months and 1 year after surgery. Method of measurement: Visual Analog Scale pain score - Knee Injury and Osteoarthritis Outcome Score - Forgotten Joint Score - Range of motion.;Complications of surgery. Timepoint: During one year after the operation. Method of measurement: History and examination.