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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03274830
Other study ID # 1602_V03_10042019
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 5, 2020
Est. completion date September 2034

Study information

Verified date September 2023
Source Mathys Ltd Bettlach
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 102
Est. completion date September 2034
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Informed consent form (signed by participant and investigator) - Primary implantation - Suffer from primary or secondary osteoarthritis of the hip, femoral head and neck fractures or necrosis of the femoral head. In all cases a stable anchoring of the implant has to be possible. - Age at inclusion: between 18 and 75 years old - Willing to participate in the follow-up examinations - Complete recovery is expected Exclusion Criteria: - Missing informed consent form (signed by participant and investigator) - Known or suspected non-compliance (e.g. drug or alcohol abuse) - Enrolment of the investigator, his/her family, employees and other dependent persons - Patients younger 18 years old - Revision surgery - Presence of sepsis or malignant tumours - ASA (American Society of Anesthesiologists) Classification >3 - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
aneXys
150 patients with the aneXys cup

Locations

Country Name City State
Germany DRK Kliniken Berlin | Köpernick Berlin
Germany DRK Kliniken Berlin | Westend Berlin
Germany Universitätsklinikum Leipzig Leipzig

Sponsors (1)

Lead Sponsor Collaborator
Mathys Ltd Bettlach

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Osteolysis The first endpoint of interest is the occurrence of osteolysis around the cup. 6-12 weeks - 10 years
Other Lucent lines The second endpoint of interest is the occurrence of lucent lines around the cup. 6-12 weeks - 10 years
Other Complications The first safety endpoint will be the number of complications with respect to the investigational product. post-op - 10 years
Other Revisions The second safety endpoint will be the number revisions with respect to the investigational product. post-op - 10 years
Primary 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
Secondary Harris Hip Score The secondary endpoint will be the determination of the clinical outcome using the Harris Hip Score. 10 years
Secondary Visual analogue scale vor pain The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for pain. 10 years
Secondary 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
Secondary The Western Ontario and McMaster Universities Osteoarthritis Index The secondary endpoint will be the determination of the clinical outcome using the WOMAC. 10 years
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