Trials / Active Not Recruiting
Active Not RecruitingNCT03274830
A Post Market Clinical Follow-up Study With the aneXys Cup
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 102 (actual)
- Sponsor
- Mathys Ltd Bettlach · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | aneXys | 150 patients with the aneXys cup |
Timeline
- Start date
- 2020-03-05
- Primary completion
- 2024-03-18
- Completion
- 2032-03-01
- First posted
- 2017-09-07
- Last updated
- 2026-02-06
Locations
3 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03274830. Inclusion in this directory is not an endorsement.