Comparison Between Medial Pivot Versus Symmetric Insert Total Knee Arthroplasty

• Sponsor: Elda University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04769544
• Collaborator: Universidad Miguel Hernandez de Elche (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 2.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Device: total knee arthroplasty with medial pivot tibial insert or symmetrical insert	N/A

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:

1. Study group: patients treated with a medial pivot TKA.

2. 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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
• Official Title: Comparison Between Medial Pivot Versus Symmetric Insert Total Knee Arthroplasty: A Randomized Controlled Study
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Medial pivot group Device used: medial pivot total knee arthroplasty design	Device: total knee arthroplasty with medial pivot tibial insert or symmetrical insert; standard surgical implantation of total knee arthroplasty
Active Comparator: Conventional group Device used: conventional total knee arthroplasty design	Device: total knee arthroplasty with medial pivot tibial insert or symmetrical insert; standard surgical implantation of total knee arthroplasty

Outcome Measures

Primary Outcome Measures

1. The Knee Society Score [2 years]

   Functional KSS score (range 0-100) with higher scores as better outcome. A good result is defined as 70 points or greater

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Elda University Hospital	Elda	Alicante	Spain	03600

Sponsors and Collaborators

• Elda University Hospital
• Universidad Miguel Hernandez de Elche

Investigators

• Principal Investigator: Alejandro Lizaur-Utrilla, MD, PhD, Elda University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alejandro Lizaur-Utrilla, PhD, MD, Head of Orthopaedic Surgery Department, Elda University Hospital
• ClinicalTrials.gov Identifier: NCT04769544
• Other Study ID Numbers: MedialPivotPTR2021
• First Posted: Feb 24, 2021
• Last Update Posted: Apr 7, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alejandro Lizaur-Utrilla, PhD, MD, Head of Orthopaedic Surgery Department, Elda University Hospital: knee osteoarthritis; Total knee arthroplasty; Medial pivot
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Apr 7, 2022