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

NCT03274830 | Active Not Recruiting

• 1 other identifier: 1602_V03_10042019
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 3

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.

Conditions

Arthroplasty, Replacement, Hip

Keywords

primary osteoarthritis; secondary osteoarthritis; femoral head fracture; necrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Harris Hip Score

  10 years

• Visual analogue scale vor pain

  10 years

• Visual analogue scale for satisfaction

  10 years

• The Western Ontario and McMaster Universities Osteoarthritis Index

  10 years

Other Outcomes (4)

• Osteolysis

  6-12 weeks - 10 years

• Lucent lines

  6-12 weeks - 10 years

• Complications

  post-op - 10 years

Study Arms (1)

aneXys

cases with aneXys cup and Mathys hip stem

Device: aneXys

Interventions

aneXys DEVICE

150 patients with the aneXys cup

aneXys

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

see eligibility criteria

You may qualify if:

• 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.
• Willing to participate in the follow-up examinations
• Complete recovery is expected

You may not qualify if:

• 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

Sponsors & Collaborators

• Mathys Ltd Bettlach: lead

Study Sites (3)

DRK Kliniken Berlin | Köpernick

Berlin, Germany

Location

DRK Kliniken Berlin | Westend

Berlin, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04107, Germany

Location

MeSH Terms

Conditions

Necrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Roth, Prof.

  Universitätsklinik Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: September 7, 2017
• Study Start: March 5, 2020
• Primary Completion: March 18, 2024
• Study Completion (Estimated): March 1, 2032
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)