- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03424174
Clinical Outcome and Cytokine Expression After TKA (TKA)
May 2, 2023 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
-
-
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
|
Implantation coated Total Knee Arthroplasty
|
Active Comparator: Standard Total Knee Arthroplasty
Implantation 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
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 (Anticipated)
December 31, 2023
Study Completion (Anticipated)
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)
May 3, 2023
Last Update Submitted That Met QC Criteria
May 2, 2023
Last Verified
May 1, 2023
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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