Comparison Between Medial Pivot Versus Symmetric Insert Total Knee Arthroplasty
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Knee Osteoarthritis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients will be treated surgically with a TKA. The two patient groups will include: 1) Study group treated a medial pivot TKA; 2) Control group treated with a conventional TKA. Patients will be followed at regular postoperative intervals by orthopaedic surgeons not involved in the surgeries or cares.Masking: Double (Participant, Outcomes Assessor)Masking Description: Double Blind. Patients will be allocated into two groups based on randomized 20-block method by an independent assistant using computer generated randomization. Both patients and evaluators will be blinded with regard to the TKA design.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 99 years
- Gender
- Both males and females
Description
Candidates for the study will be consecutive patients eligible for total knee arthroplasty (TKA) at our center. All patients meeting inclusion criteria will be recruited for enrollment into the study. Informed consent will be obtained from the patient prior to randomization. At that time, each patie...
Candidates for the study will be consecutive patients eligible for total knee arthroplasty (TKA) at our center. All patients meeting inclusion criteria will be recruited for enrollment into the study. Informed consent will be obtained from the patient prior to randomization. At that time, each patient will be randomized into one of two groups by an independent staff using computer generated randomization and allocation concealment. The two patient groups will include: Study group: patients treated with a medial pivot TKA. Control group: patients treated with a conventional TKA. Patients will be preoperatively assessed and postoperatively at regular intervals (6mo, 12 mo, and then annually) by orthopaedic surgeons not involved in the surgeries or cares.
Tracking Information
- NCT #
- NCT04769544
- Collaborators
- Universidad Miguel Hernandez de Elche
- Investigators
- Principal Investigator: Alejandro Lizaur-Utrilla, MD, PhD Elda University Hospital
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