Clinical Outcome and Cytokine Expression After TKA

Not Applicable

Active, not recruiting

• Conditions: Osteoarthritis
• Interventions: Device: Coated Total Knee Arthroplasty; Device: Standard Total Knee Arthroplasty

• Registration Number: NCT03424174
• Lead Sponsor: Technische Universität Dresden

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

Study Timeline

• Study First Submitted: 2016-03-17
• Study Start: 2017-01-04
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-06
• Primary Completion: 2023-12-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Primary and secondary osteoarthritis
• understanding of german language

Exclusion Criteria

• necessity of constrained TKA
• existence of other joint implants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coated Total Knee Arthroplasty	Coated Total Knee Arthroplasty	Implantation coated Total Knee Arthroplasty
Standard Total Knee Arthroplasty	Standard Total Knee Arthroplasty	Implantation Standard Total Knee Arthroplasty

Primary Outcome Measures

Name	Time	Method
cytokine expression	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

Name	Time	Method
Quality of life assessed with EQ 5D	pre-op, 3 months, 1 and 3 years post-op	EQ 5D Index (0 - 1.0, best 1.0)
Patient reported outcome assessed with Oxford Knee Score	pre-op, 3 months, 1 and 3 years post-op	Oxford Knee Score (0 - 48 points, best 48)
Function assessed with Knee Society Score	pre-op, 3 months, 1 and 3 years post-op	Knee Society Score (0 - 100 points, best 100)
Activity assessed with UCLA activity score	pre-op, 3 months, 1 and 3 years post-op	UCLA activity score (0 - 10 points, best 10)

Trial Locations

Locations (1)

University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden; 🇩🇪 Dresden, Saxonia, Germany