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Clinical Outcome and Cytokine Expression After TKA (TKA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03424174
Recruitment Status : Active, not recruiting
First Posted : February 6, 2018
Last Update Posted : August 23, 2021
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

Study Description
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Brief Summary:
Comparison of coated and uncoated TKA with regard to cytokine expression and clinical results

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Coated Total Knee Arthroplasty Device: Standard Total Knee Arthroplasty Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Outcome and Cytokine Expression in Blood After Coated in Comparison to Uncoated TKA
Actual Study Start Date : January 4, 2017
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)


Other Outcome Measures:
  1. adverse events [ Time Frame: 3 month, 1 year and 3 years post-op ]
    adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary and secondary osteoarthritis
  • understanding of german language

Exclusion Criteria:

  • necessity of constrained TKA
  • existence of other joint implants
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424174


Locations
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Germany
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
Dresden, Saxonia, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Investigators
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Principal Investigator: Jörg Lützner, MD University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden
More Information
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Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT03424174    
Other Study ID Numbers: TKA cytokine
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Technische Universität Dresden:
TKA, cytokine, coating
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases