Clinical Outcome and Cytokine Expression After TKA (TKA)

August 6, 2024 updated by: Technische Universität Dresden

Clinical Outcome and Cytokine Expression in Blood After Coated in Comparison to Uncoated TKA

Comparison of coated and uncoated TKA with regard to cytokine expression and clinical results

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Comparison of coated and uncoated TKA with regard to cytokine expression and clinical results at 3 months, 1 year and 3 years after surgery

Study Type

Interventional

Enrollment (Actual)

80

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:

  • Primary and secondary osteoarthritis
  • understanding of german language

Exclusion Criteria:

  • necessity of constrained TKA
  • existence of other joint implants

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: Coated Total Knee Arthroplasty
Implantation coated Total Knee Arthroplasty
Device: Coated Total Knee Arthroplasty
Implantation coated Total Knee Arthroplasty
Active Comparator: Standard Total Knee Arthroplasty
Implantation Standard Total Knee Arthroplasty
Device: Standard Total Knee Arthroplasty
Implantation StandardTotal Knee Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cytokine expression
Time Frame: pre-op, 1 and 3 years post-op
Changes of cytokine expression 1 and 3 years after surgery compared to pre-op
pre-op, 1 and 3 years post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Function assessed with Knee Society Score
Time Frame: pre-op, 3 months, 1 and 3 years post-op
Knee Society Score (0 - 100 points, best 100)
pre-op, 3 months, 1 and 3 years post-op
Patient reported outcome assessed with Oxford Knee Score
Time Frame: pre-op, 3 months, 1 and 3 years post-op
Oxford Knee Score (0 - 48 points, best 48)
pre-op, 3 months, 1 and 3 years post-op
Quality of life assessed with EQ 5D
Time Frame: pre-op, 3 months, 1 and 3 years post-op
EQ 5D Index (0 - 1.0, best 1.0)
pre-op, 3 months, 1 and 3 years post-op
Activity assessed with UCLA activity score
Time Frame: pre-op, 3 months, 1 and 3 years post-op
UCLA activity score (0 - 10 points, best 10)
pre-op, 3 months, 1 and 3 years post-op

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: 3 month, 1 year and 3 years post-op
adverse events
3 month, 1 year and 3 years post-op

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, MD, University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus 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)

January 4, 2017

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

January 31, 2018

First Posted (Actual)

February 6, 2018

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TKA cytokine

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

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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