Clinical Outcome and Cytokine Expression After TKA
TKA
1 other identifier
interventional
80
1 country
1
Brief Summary
Comparison of coated and uncoated TKA with regard to cytokine expression and clinical results
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2016
CompletedStudy Start
First participant enrolled
January 4, 2017
CompletedFirst Posted
Study publicly available on registry
February 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
ExpectedAugust 7, 2024
August 1, 2024
7 years
March 17, 2016
August 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cytokine expression
Changes of cytokine expression 1 and 3 years after surgery compared to pre-op
pre-op, 1 and 3 years post-op
Secondary Outcomes (4)
Function assessed with Knee Society Score
pre-op, 3 months, 1 and 3 years post-op
Patient reported outcome assessed with Oxford Knee Score
pre-op, 3 months, 1 and 3 years post-op
Quality of life assessed with EQ 5D
pre-op, 3 months, 1 and 3 years post-op
Activity assessed with UCLA activity score
pre-op, 3 months, 1 and 3 years post-op
Other Outcomes (1)
adverse events
3 month, 1 year and 3 years post-op
Study Arms (2)
Coated Total Knee Arthroplasty
EXPERIMENTALImplantation coated Total Knee Arthroplasty
Standard Total Knee Arthroplasty
ACTIVE COMPARATORImplantation Standard Total Knee Arthroplasty
Interventions
Implantation coated Total Knee Arthroplasty
Implantation StandardTotal Knee Arthroplasty
Eligibility Criteria
You may qualify if:
- Primary and secondary osteoarthritis
- understanding of german language
You may not qualify if:
- necessity of constrained TKA
- existence of other joint implants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
Dresden, Saxony, 01307, Germany
Related Publications (1)
Tille E, Beyer F, Lutzner C, Postler A, Thomas P, Summer B, Lutzner J. No difference in patient reported outcome and inflammatory response after coated and uncoated total knee arthroplasty - a randomized controlled study. BMC Musculoskelet Disord. 2023 Dec 14;24(1):968. doi: 10.1186/s12891-023-07061-x.
PMID: 38098024DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jörg Lützner, MD
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2016
First Posted
February 6, 2018
Study Start
January 4, 2017
Primary Completion
December 31, 2023
Study Completion (Estimated)
December 31, 2028
Last Updated
August 7, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share