Clinical Outcome and Cytokine Expression After TKA

Osteoarthritis Clinical Trial

— TKA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03424174
• Other study ID #: TKA cytokine
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 4, 2017
• Est. completion date: December 31, 2028

Study information

• Verified date: May 2023
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary and secondary osteoarthritis

• understanding of german language

Exclusion Criteria:

• necessity of constrained TKA

• existence of other joint implants

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Coated Total Knee Arthroplasty
Implantation coated Total Knee Arthroplasty
• Standard Total Knee Arthroplasty
Implantation StandardTotal Knee Arthroplasty

Locations

Country	Name	City	State
Germany	University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden	Dresden	Saxonia

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse events	adverse events	3 month, 1 year and 3 years post-op
Primary	cytokine expression	Changes of cytokine expression 1 and 3 years after surgery compared to pre-op	pre-op, 1 and 3 years post-op
Secondary	Function assessed with Knee Society Score	Knee Society Score (0 - 100 points, best 100)	pre-op, 3 months, 1 and 3 years post-op
Secondary	Patient reported outcome assessed with Oxford Knee Score	Oxford Knee Score (0 - 48 points, best 48)	pre-op, 3 months, 1 and 3 years post-op
Secondary	Quality of life assessed with EQ 5D	EQ 5D Index (0 - 1.0, best 1.0)	pre-op, 3 months, 1 and 3 years post-op
Secondary	Activity assessed with UCLA activity score	UCLA activity score (0 - 10 points, best 10)	pre-op, 3 months, 1 and 3 years post-op