Substitution of the PCL in TKA With UC or PS Design

February 16, 2024 updated by: Technische Universität Dresden

Substitution of the Posterior Cruciate Ligament in Total Knee Arthroplasty With Ultracongruent Insert or Posterior Stabilzed Design

RCT comparing UC and PS TKA

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

RCT comparing TKA with either ultraconguent insert or posterior stabilized design for substitution of the posterior cruciate ligament

Study Type

Interventional

Enrollment (Actual)

127

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:

  • scheduled for TKA

Exclusion Criteria:

  • higher constraint needed

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: UC
Total Knee Arthroplasty with an ultracongruent insert
Other: TKA
Total Knee Arthroplasty
Active Comparator: PS
Total Knee Arthroplasty with posterior stabilized design
Other: TKA
Total Knee Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ROM
Time Frame: 10 years
Range of motion
10 years
Patient reported outcome
Time Frame: 10 years
Oxford Knee Score min 0 points (worst), max 48 points (best)
10 years

Collaborators and Investigators

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

Sponsor

Technische Universität Dresden

Investigators

  • Principal Investigator: Jörg Lützner, University Hospital Carl Gustav Carus, TU 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)

November 1, 2012

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

December 17, 2020

First Submitted That Met QC Criteria

December 17, 2020

First Posted (Actual)

December 22, 2020

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TKA UC PS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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