Back to resultsClinical Outcome and Cytokine Expression After TKA (TKA)
Primary Purpose
Osteoarthritis
Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Coated Total Knee Arthroplasty
Standard Total Knee Arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring TKA, cytokine, coating
Eligibility Criteria
Inclusion Criteria:
- Primary and secondary osteoarthritis
- understanding of german language
Exclusion Criteria:
- necessity of constrained TKA
- existence of other joint implants
Sites / Locations
- University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Coated Total Knee Arthroplasty
Standard Total Knee Arthroplasty
Arm Description
Implantation coated Total Knee Arthroplasty
Implantation Standard Total Knee Arthroplasty
Outcomes
Primary Outcome Measures
cytokine expression
Changes of cytokine expression 1 and 3 years after surgery compared to pre-op
Secondary Outcome Measures
Function assessed with Knee Society Score
Knee Society Score (0 - 100 points, best 100)
Patient reported outcome assessed with Oxford Knee Score
Oxford Knee Score (0 - 48 points, best 48)
Quality of life assessed with EQ 5D
EQ 5D Index (0 - 1.0, best 1.0)
Activity assessed with UCLA activity score
UCLA activity score (0 - 10 points, best 10)
Full Information
NCT ID
NCT03424174
First Posted
March 17, 2016
Last Updated
May 2, 2023
Sponsor
Technische Universität Dresden
1. Study Identification
Unique Protocol Identification Number
NCT03424174
Brief Title
Clinical Outcome and Cytokine Expression After TKA
Acronym
TKA
Official Title
Clinical Outcome and Cytokine Expression in Blood After Coated in Comparison to Uncoated TKA
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 4, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of coated and uncoated TKA with regard to cytokine expression and clinical results
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
TKA, cytokine, coating
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coated Total Knee Arthroplasty
Arm Type
Experimental
Arm Description
Implantation coated Total Knee Arthroplasty
Arm Title
Standard Total Knee Arthroplasty
Arm Type
Active Comparator
Arm Description
Implantation Standard Total Knee Arthroplasty
Intervention Type
Device
Intervention Name(s)
Coated Total Knee Arthroplasty
Intervention Description
Implantation coated Total Knee Arthroplasty
Intervention Type
Device
Intervention Name(s)
Standard Total Knee Arthroplasty
Intervention Description
Implantation StandardTotal Knee Arthroplasty
Primary Outcome Measure Information:
Title
cytokine expression
Description
Changes of cytokine expression 1 and 3 years after surgery compared to pre-op
Time Frame
pre-op, 1 and 3 years post-op
Secondary Outcome Measure Information:
Title
Function assessed with Knee Society Score
Description
Knee Society Score (0 - 100 points, best 100)
Time Frame
pre-op, 3 months, 1 and 3 years post-op
Title
Patient reported outcome assessed with Oxford Knee Score
Description
Oxford Knee Score (0 - 48 points, best 48)
Time Frame
pre-op, 3 months, 1 and 3 years post-op
Title
Quality of life assessed with EQ 5D
Description
EQ 5D Index (0 - 1.0, best 1.0)
Time Frame
pre-op, 3 months, 1 and 3 years post-op
Title
Activity assessed with UCLA activity score
Description
UCLA activity score (0 - 10 points, best 10)
Time Frame
pre-op, 3 months, 1 and 3 years post-op
Other Pre-specified Outcome Measures:
Title
adverse events
Description
adverse events
Time Frame
3 month, 1 year and 3 years post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary and secondary osteoarthritis
understanding of german language
Exclusion Criteria:
necessity of constrained TKA
existence of other joint implants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jörg Lützner, MD
Organizational Affiliation
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
City
Dresden
State/Province
Saxonia
ZIP/Postal Code
01307
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Outcome and Cytokine Expression After TKA
We'll reach out to this number within 24 hrs