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The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the aneXys cup. The data will be used for an ongoing evaluation of the product safety and performance.
Prospective observational multicenter case series providing short-term migration results and long-term post-market clinical data on the safety and performance of the aneXys cup. The study includes patients undergoing primary total hip arthroplasty. In total 100 patients in 3 clinics will be included. In each clinic 10-57 consecutive patients shall be included. In addition, to meet the regulatory requirements, a total of minimum 20 cases with screw fixation shall be included in the study.
Clinical and radiological follow-up (FU) is planned after 6-12 weeks, 6 months, 1, 2, 5, 7 and 10 years. An additional FU at 3 years is planned to apply for an ODEP (Orthopaedic Data Evaluation Panel) rating.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aneXys | cases with aneXys cup and Mathys hip stem |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aneXys | Device | 150 patients with the aneXys cup |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cup migration after 2 years | The primary endpoint will be the radiographic evaluation of the acetabular cup migration based on performed EBRA measurements 2 years after surgery. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score | The secondary endpoint will be the determination of the clinical outcome using the Harris Hip Score. | 10 years |
| Visual analogue scale vor pain | The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Osteolysis | The first endpoint of interest is the occurrence of osteolysis around the cup. | 6-12 weeks - 10 years |
| Lucent lines | The second endpoint of interest is the occurrence of lucent lines around the cup. |
Inclusion Criteria:
Exclusion Criteria:
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see eligibility criteria
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Roth, Prof. | Universitätsklinik Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DRK Kliniken Berlin | Köpernick | Berlin | Germany | ||||
| DRK Kliniken Berlin | Westend |
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| ID | Term |
|---|---|
| D009336 | Necrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 10 years |
| Visual analogue scale for satisfaction | The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for satisfaction. | 10 years |
| The Western Ontario and McMaster Universities Osteoarthritis Index | The secondary endpoint will be the determination of the clinical outcome using the WOMAC. | 10 years |
| 6-12 weeks - 10 years |
| Complications | The first safety endpoint will be the number of complications with respect to the investigational product. | post-op - 10 years |
| Revisions | The second safety endpoint will be the number revisions with respect to the investigational product. | post-op - 10 years |
| Berlin |
| Germany |
| Universitätsklinikum Leipzig | Leipzig | 04107 | Germany |