Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay

February 16, 2024 updated by: Technische Universität Dresden

Prospective Randomized Comparison of Cruciate-retaining and Cruciate Substituting Surgical Technique for Total Knee Arthroplasty

Compare knee flexion after cruciate-retaining and cruciate substituting Total Knee Arthroplasty.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to compare knee Flexion after cruciate-retaining (CR) and cruciate-substituting (posterior stabilized - PS) Total Knee Arthroplasty (TKA).

For this purpose, flexion and extension of the knee joint are measured using a goniometer preoperatively and up to ten years after surgery In addition, the clinical outcome will be assessed and evaluated using internationally recognised and evaluated scores (Knee Society Score, Oxford Knee Score, EQ5D, UCLA Activity Score).

Patients are randomized to receive a PS or CR TKA. Patients are assessed before surgery, after 3 months, 1 year, 2 years, 5 years, 7 years and 10 years postoperatively.

Study Type

Interventional

Enrollment (Estimated)

140

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

  • Germany
    • Saxonia
      • Dresden, Saxonia, Germany, 01307
        • University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Indication for TKA with a non-linked, bicondylar total knee replacement
  • written informed consent

Exclusion Criteria:

  • Chronic pain patients
  • Neuromuscular Diseases
  • general illnesses that make mobilisation more difficult and/or prevent follow-up
  • Known posterior cruciate ligament insufficiency
  • Need for a higher degree of linkage
  • BMI over 40 kg/m²
  • Study doctor, his family, employees or other dependent persons

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PS
Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty.
Device: PS TKA
Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty.
Active Comparator: CR
Implantation of a cruciate retaining Total Knee Arthroplasty.
Device: CR TKA
Implantation of a cruciate retaining Total Knee Arthroplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Flexion
Time Frame: 1 year after surgery
Knee flexion measured using a goniometer
1 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Function assessed by the Knee Society Score
Time Frame: 10 years after surgery
Knee Society Score
10 years after surgery
Patient Reported Outcome
Time Frame: 10 years after surgery
Oxford Knee Score
10 years after surgery
Health-related Quality of Life
Time Frame: 10 years after surgery
EQ-5D-3L
10 years after surgery
Activity assessed by UCLA activity score
Time Frame: 10 years after surgery
UCLA activity score
10 years after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 1 year after surgery
Adverse Events
1 year after surgery

Collaborators and Investigators

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

Sponsor

Technische Universität Dresden

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 1, 2018

Primary Completion (Actual)

June 1, 2020

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

March 7, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TKA CR vs PS

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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