Clinical Outcome and Cytokine Expression After TKA

N/AActive Not RecruitingNCT03424174

Technische Universität Dresden80 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis

Interventions

Coated Total Knee ArthroplastyDEVICE

Implantation coated Total Knee Arthroplasty

Standard Total Knee ArthroplastyDEVICE

Implantation StandardTotal Knee Arthroplasty

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary and secondary osteoarthritis * understanding of german language Exclusion Criteria: * necessity of constrained TKA * existence of other joint implants

Locations (1)

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

Dresden, Saxony, Germany

Outcomes

Primary Outcomes

cytokine expression

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 Outcomes

Function assessed with Knee Society Score

Knee Society Score (0 - 100 points, best 100)

Time frame: pre-op, 3 months, 1 and 3 years post-op

Patient reported outcome assessed with Oxford Knee Score

Oxford Knee Score (0 - 48 points, best 48)

Time frame: pre-op, 3 months, 1 and 3 years post-op

Quality of life assessed with EQ 5D

EQ 5D Index (0 - 1.0, best 1.0)

Time frame: pre-op, 3 months, 1 and 3 years post-op

Activity assessed with UCLA activity score

UCLA activity score (0 - 10 points, best 10)

Time frame: pre-op, 3 months, 1 and 3 years post-op

Data from ClinicalTrials.gov

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