Osteoarthritis
Conditions
Keywords
TKA, cytokine, coating
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
Interventions
Implantation coated Total Knee Arthroplasty
Implantation StandardTotal Knee Arthroplasty
Sponsors
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary and secondary osteoarthritis * understanding of german language
Exclusion criteria
* necessity of constrained TKA * existence of other joint implants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Function assessed with Knee Society Score | pre-op, 3 months, 1 and 3 years post-op | Knee Society Score (0 - 100 points, best 100) |
| 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) |
| 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) |
| Activity assessed with UCLA activity score | pre-op, 3 months, 1 and 3 years post-op | UCLA activity score (0 - 10 points, best 10) |
Other
| Measure | Time frame | Description |
|---|---|---|
| adverse events | 3 month, 1 year and 3 years post-op | adverse events |
Countries
Germany
Outcome results
None listed