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

Active, not recruiting

• Conditions: Arthroplasty, Replacement, Hip
• Interventions: Device: aneXys

• Registration Number: NCT03274830
• Lead Sponsor: Mathys Ltd Bettlach

Brief 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.

Study Timeline

• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-09-04
• Study First Posted: 2017-09-07
• Study Start: 2020-03-05
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-03
• Primary Completion: 2024-09
• Study Completion: 2034-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 102

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
aneXys	aneXys	cases with aneXys cup and Mathys hip stem

Primary Outcome Measures

Name	Time	Method
Cup migration after 2 years	2 years	The primary endpoint will be the radiographic evaluation of the acetabular cup migration based on performed EBRA measurements 2 years after surgery.

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale vor pain	10 years	The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for pain.
The Western Ontario and McMaster Universities Osteoarthritis Index	10 years	The secondary endpoint will be the determination of the clinical outcome using the WOMAC.
Harris Hip Score	10 years	The secondary endpoint will be the determination of the clinical outcome using the Harris Hip Score.
Visual analogue scale for satisfaction	10 years	The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for satisfaction.

Trial Locations

Locations (3)

DRK Kliniken Berlin | Westend; 🇩🇪 Berlin, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

DRK Kliniken Berlin | Köpernick; 🇩🇪 Berlin, Germany