Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Aesculap AG | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
All metal implants release metal ions because of corrosion. Total knee arthroplasty implants have large metal surface areas and therefore substantial potential for corrosion. It is planned to compare changes in serum levels of metal ions in patients after implantation of cemented unconstrained total knee arthroplasty covered with or without a passivating surface. Serum concentrations of chromium, cobalt, molybdenum and nickel will be analyzed and compared between the two groups, as well as with those of 130 control patients without implants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coated Total Knee Arthroplasty | Experimental | allergy coated TKA |
|
| Standard Total Knee Arthroplasty | Active Comparator | normal TKA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coated Total Knee Arthroplasty | Device | Implantation of a coated Total Knee Arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Metal ion concentration in serum after TKA (Cr, Co, Mb, Ni) | 1 y and 5y |
| Measure | Description | Time Frame |
|---|---|---|
| Hypersensitivity against metal | 1 y |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jörg Lützner, MD | University Hospital Dresden, Orthopaedic Department | Principal Investigator |
| Stephan Kirschner, MD | University Hospital Dresden, Orthopaedic Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Dresden, Orthopaedic Department | Dresden | 01307 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35147719 | Derived | Lutzner J, Beyer F, Lutzner C, Thomas P, Summer B. Increased inflammatory response is associated with less favorable functional results 5 years after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2023 Apr;31(4):1316-1322. doi: 10.1007/s00167-021-06836-w. Epub 2022 Feb 11. | |
| 19828019 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard Total Knee Arthroplasty | Device | Implantation of a Standard Total Knee Arthroplasty |
|
| Lutzner J, Dinnebier G, Hartmann A, Gunther KP, Kirschner S. Study rationale and protocol: prospective randomized comparison of metal ion concentrations in the patient's plasma after implantation of coated and uncoated total knee prostheses. BMC Musculoskelet Disord. 2009 Oct 14;10:128. doi: 10.1186/1471-2474-10-128. |