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

Investigating the functional outcomes of using medial congruent prostheses and comparing its results with Persona's posterior-stabilized prostheses in total knee arthroplasty in patients: A double-blind randomized clinical trial study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191222045857N2

Enrollment

Registered

2023-08-18

Start date

2023-10-07

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe end-stage knee osteoarthritis eligible for TKA surgery. Osteoarthritis of knee

Interventions

Intervention 1: Intervention group: There are patients in whom knee joint replacement surgery is performed using medial congruent prostheses. This group will have the same pre-operative training, pre-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFardis Vosoughi

Tehran University of Medical Sciences

f-vosoughi@razi.tums.ac.ir+98 21 8827 0873

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026