Comparison Between Medial Pivot Versus Symmetric Insert Total Knee Arthroplasty
Primary Purpose
Knee Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
total knee arthroplasty with medial pivot tibial insert or symmetrical insert
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, Total knee arthroplasty, Medial pivot
Eligibility Criteria
Inclusion Criteria:
- Primary osteoarthritis of the knee
- 50 years and older
- Participants must be able to give informed consent
Exclusion Criteria:
- Inflammatory arthritis
- Traumatic etiology
- Neurologic disease
- Neoplastic disease
- Morbid obesity
- Severe collateral ligament instability (> 10° varus/valgus)
- Severe knee misalignment (greater than 10° of varus or valgus)
- Flexion contracture greater than 15º
- Prior surgery on the affected knee (except meniscus)
- Knee arthroplasty in the contralateral knee
Sites / Locations
- Elda University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Medial pivot group
Conventional group
Arm Description
Device used: medial pivot total knee arthroplasty design
Device used: conventional total knee arthroplasty design
Outcomes
Primary Outcome Measures
The Knee Society Score
Functional KSS score (range 0-100) with higher scores as better outcome. A good result is defined as 70 points or greater
Secondary Outcome Measures
Full Information
NCT ID
NCT04769544
First Posted
February 21, 2021
Last Updated
April 6, 2022
Sponsor
Elda University Hospital
Collaborators
Universidad Miguel Hernandez de Elche
1. Study Identification
Unique Protocol Identification Number
NCT04769544
Brief Title
Comparison Between Medial Pivot Versus Symmetric Insert Total Knee Arthroplasty
Official Title
Comparison Between Medial Pivot Versus Symmetric Insert Total Knee Arthroplasty: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Elda University Hospital
Collaborators
Universidad Miguel Hernandez de Elche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The functional outcome and longevity of total knee arthroplasty (TKA) is still a concern. Despite various developments in TKA designs, including fixed or mobile bearing, cruciate retaining or posterior stabilized, multi or single radius, it remains unclear which design is superior for achieving a physiological kinematic.
In normal healthy knees the medial and lateral tibial condyles are different: the medial is almost flat while the lateral is somewhat convex. Thus, the movement during flexion is asymmetric: during the flexion, the medial condyle is stable throughout the range of motion while the lateral condyle slides anteroposteriorly with respect to femur). Therefore, the native knee requires a specific degree of rollback of the lateral compartment coupled with a medial pivot, which leads to an external axial rotation of the femur. This rollback is thought to be even more pronounced with increasing knee flexion angles to enable deep flexion without excessive shear forces acting at the patella or overloading the extensor mechanism.
In addition, stability throughout flexion is a crucial element to normal knee function. Most TKA designs removal of the ACL, and the PCL in posterior-stabilized design, but the TKA do not fully restore the function of those ligaments.
Based on this philosophy, the medial pivot TKA was designed to provide better function, patient satisfaction and increased survival.
The objective of this study is to analyze whether the medial pivot design provides better outcome and prosthesis survival than conventional total knee arthroplasty.
Detailed 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, Total knee arthroplasty, Medial pivot
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Medial pivot group
Arm Type
Active Comparator
Arm Description
Device used: medial pivot total knee arthroplasty design
Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
Device used: conventional total knee arthroplasty design
Intervention Type
Device
Intervention Name(s)
total knee arthroplasty with medial pivot tibial insert or symmetrical insert
Intervention Description
standard surgical implantation of total knee arthroplasty
Primary Outcome Measure Information:
Title
The Knee Society Score
Description
Functional KSS score (range 0-100) with higher scores as better outcome. A good result is defined as 70 points or greater
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary osteoarthritis of the knee
50 years and older
Participants must be able to give informed consent
Exclusion Criteria:
Inflammatory arthritis
Traumatic etiology
Neurologic disease
Neoplastic disease
Morbid obesity
Severe collateral ligament instability (> 10° varus/valgus)
Severe knee misalignment (greater than 10° of varus or valgus)
Flexion contracture greater than 15º
Prior surgery on the affected knee (except meniscus)
Knee arthroplasty in the contralateral knee
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro Lizaur-Utrilla, MD, PhD
Phone
+34 966989019
Email
lizaur1@telefonica.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Lizaur-Utrilla, MD, PhD
Organizational Affiliation
Elda University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elda University Hospital
City
Elda
State/Province
Alicante
ZIP/Postal Code
03600
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Lizaur-Utrilla, PhD, MD
Email
lizaur1@telefonica.net
First Name & Middle Initial & Last Name & Degree
Alejandro Lizaur-Utrilla, PhD, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD that underlie results in a publication
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
Request to the principal investigator
Learn more about this trial
Comparison Between Medial Pivot Versus Symmetric Insert Total Knee Arthroplasty
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