Comparison Between Medial Pivot Versus Symmetric Insert Total Knee Arthroplasty

NCT04769544 | Unknown

• 1 other identifier: MedialPivotPTR2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; Total knee arthroplasty; Medial pivot

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Study Arms (2)

Medial pivot group

ACTIVE COMPARATOR

Device used: medial pivot total knee arthroplasty design

Device: total knee arthroplasty with medial pivot tibial insert or symmetrical insert

Conventional group

ACTIVE COMPARATOR

Device used: conventional total knee arthroplasty design

Device: total knee arthroplasty with medial pivot tibial insert or symmetrical insert

Interventions

total knee arthroplasty with medial pivot tibial insert or symmetrical insert DEVICE

standard surgical implantation of total knee arthroplasty

Conventional group; Medial pivot group

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary osteoarthritis of the knee
• years and older
• Participants must be able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Elda University Hospital: lead
• Universidad Miguel Hernandez de Elche: collaborator

Study Sites (1)

Elda University Hospital

Elda, Alicante, 03600, Spain

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Alejandro Lizaur-Utrilla, MD, PhD

  Elda University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro Lizaur-Utrilla, MD, PhD

CONTACT

+34 966989019; lizaur1@telefonica.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Orthopaedic Surgery Department

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: February 24, 2021
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after publication
• Access Criteria: Request to the principal investigator

Locations

ES (1)