Comparison Of Outcomes After Knee Arthroplasty Using Posterior-Substituting Versus Cruciate-Retaining Prostheses

December 4, 2024 updated by: Bezmialem Vakif University

Comparison Of Outcomes After Bilateral Simultaneous Total Knee Arthroplasty Using Posterior-Substituting Versus Cruciate-Retaining Prostheses

Total knee replacement is used in the treatment of patients with knee arthritis, rheumatoid arthritis and other knee disorders. Today, there are basically two designs; It cuts the posterior cruciate ligament (PS) and protects the posterior cruciate ligament (CR). Although there is no clear study suggesting which design is better, research on this subject has increased recently. the investigators aim is to define the superiority of these two designs over each other. Preoperative and postoperative joint range of motion examinations were performed on both knees separately. WOMAC and OXFORD scores were examined separately for both knees.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Total knee arthroplasty is used to treat patients with osteoarthritis, rheumatoid arthritis, and other knee disorders. Today, there are basically two primary designs; posterior cruciate Substituting (PS) and protects the posterior cruciate -Retaining (CR). However, it is still controversial which approach is good, as both CR and PS have advantages and disadvantages. Proponents of the posterior cruciate retaining system argue that it provides natural stability, wider joint range of motion, better proprioception, and better knee kinematics. In addition, proponents of the posterior cruciate substituting system argue that it provides more harmonious articulation and a wider flexion range.

As a result, although there is no clear study suggesting which design is better, research on this subject has increased recently. Our aim is to define the superiority of these two designs over each other.

Patients with the same stage of knee osteoarthritis in both knees were selected. Total knee arthroplasty was performed in the same session by making the appropriate design for the appropriate knee simultaneously. Preoperative and postoperative joint range of motion examinations were performed on both knees separately. WOMAC and OXFORD scores were examined separately for both knees.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Bezmialem Vakıf University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with primary osteoarthritis of both knees
  2. Patients with secondary osteoarthritis of both knees

Exclusion Criteria:

  1. Patients with primary osteoarthritis in both knees and undergoing unilateral knee prosthesis
  2. Patients with secondary osteoarthritis in both knees and who underwent unilateral knee prosthesis
  3. Patients with primary osteoarthritis in both knees and who underwent bilateral knee prosthesis in different sessions
  4. Patients with secondary osteoarthritis in both knees and who underwent bilateral knee prosthetics in different sessions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A knee of a patient with osteoarthritis of both knees
Posterior cruciate ligament protective approach in patients with knee osteoarthritis
Procedure: posterior cruciate ligament-retaining prostheses
Posterior cruciate ligament protective approach in patients with knee osteoarthritis
Active Comparator: The other knee of a patient with osteoarthritis in both knees
Posterior cruciate ligament transection approach in patients with knee osteoarthritis
Procedure: posterior cruciate ligament-substituting prostheses
Posterior cruciate ligament transection approach in patients with knee osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motions
Time Frame: 3 year
Preoperative and postoperative knee flexion and extension degrees of the patients were measured.
3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC Score (Score from 0 to 100)
Time Frame: 3 year
Preoperative and postoperative WOMAC score of the patients were examined.
3 year
OXFORD Knee Score(Score from 0 to 60)
Time Frame: 3 year
Preoperative and postoperative OXFORD score of the patients were examined.
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2021

Primary Completion (Actual)

September 20, 2023

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 14, 2023

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00013890

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

I do not think it is right that the data of the patients in the study can be seen by everyone.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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