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The objective of this study is to collect outcome information on patients requiring Total Knee Replacement (TKR) in primary or revision cases and therefore receiving the LINK® Endo-Model® SL® under routine conditions.
Post Market Clinical Follow-ups (PMCF) through observational investigations are an important tool to detect infrequent complications or problems, events specific to defined patient populations and long term performance issues under routine condition. Against this background a prospective multi-center study with the LINK® Endo-Model® SL® will be conducted.
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| Measure | Description | Time Frame |
|---|---|---|
| KOOS | Knee Injury and Osteoarthritis Outcome Score | 1 yr, 3 yrs and 5 yrs |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Rate of implant related, surgery related and systemic complications | At each Follow-up, up to 5 years |
| Rate of subsequent surgical interventions | Different surgical interventions |
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Inclusion criteria
Exclusion criteria
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All subjects enrolled in the PMCF in compliance with the inclusion/exclusion criteria who signed the Informed Consent Form and received the Endo-Model SL® prosthesis, will be included in the primary and secondary endpoint analysis.
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Lohmann, Prof. Dr. | Medizinische Fakultät Orthopädische Universitätsklinik (KORT), Magdeburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Carl Gustav Carus | Dresden | Saxony | 01307 | Germany | ||
| Medizinische Fakultät Orthopädische Universitätsklinik (KORT) |
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| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| D001168 | Arthritis |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
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| At each Follow-up, up to 5 years |
| KSS | Knee Society Score to assess knee pain and functional knee capacity | at 3 months, 1 year and 5 years |
| Prosthetic Survival Rate | Survival of the Prosthesis | up to 5 years |
| Magdeburg |
| Saxony-Anhalt |
| 39120 |
| Germany |
| Evangelisches Waldkrankenhaus Spandau | Berlin | 13589 | Germany |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |