A Post Market Clinical Follow-up Study With the aneXys Cup

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

A Post Market Clinical Follow-up Study With the aneXys Cup

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03274830
• Other study ID #: 1602_V03_10042019
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

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