A post market clinical follow-up study with the aneXys ceramys inlay DE

Recruiting

• Conditions: M16.7; M16.1; Other secondary coxarthrosis; Other primary coxarthrosis

• Registration Number: DRKS00018809
• Lead Sponsor: Mathys Orthopädie GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Participants fulfilling all of the following inclusion criteria are eligible for the study:
- 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 mentioned above
- Complete recovery is expected

Exclusion Criteria

The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
- 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

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be the occurrence of noise 2 years after surgery.

Secondary Outcome Measures

Name	Time	Method
The secondary endpoint will be the determination of the clinical outcome using the HHS (Harris Hip Score), the VAS for pain and satisfaction.