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Active, Not Recruiting

NCT Number: NCT03424174

Clinical Outcome and Cytokine Expression After TKA

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden

Dresden, Saxony, 01307, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary and secondary osteoarthritis
  • understanding of german language

Exclusion criteria

  • necessity of constrained TKA
  • existence of other joint implants

Treatment and study plan

Coated Total Knee Arthroplasty

Device

Implantation coated Total Knee Arthroplasty

Standard Total Knee Arthroplasty

Device

Implantation StandardTotal Knee Arthroplasty

Primary outcomes

  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 outcomes

  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 outcomes

  1. adverse events

    Time frame: 3 month, 1 year and 3 years post-op

    adverse events

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

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

Acronym: TKA

Important dates

Study start
2017
Primary completion
2023
Study completion
2028
First posted
Feb 6, 2018
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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