A post market clinical follow-up study with the short stem uncemented endoprosthesis (optimys) BMI > 40

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

Registration Number: DRKS00014719

Lead Sponsor: Mathys Orthopädie GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting stopped after recruiting started

Sex: All

Target Recruitment: 10

Inclusion Criteria

The patient must:
• have a BMI over 40
• the patient must sign his written consent
• Primary implantation
• suffer from primary or secondary coxarthrosis of the femoral head
• Fractures or necrosis of the femoral head in these cases, a stable anchoring of the implant must be possible
• Age at inclusion: between 18 and 75 years
• Willingness to participate in the above-mentioned follow-up examinations

Exclusion Criteria

The patient is not allowed to:
• have a known or suspected addiction (eg, drug or alcohol abuse)
• Inclusion of the study doctor, his family, employees or other dependent persons
• Missing consent form (not signed by the participant and / or the study doctor)
• Patients younger than 18 years
• Revision operations
• Presence of sepsis or malignant tumor / tumors
• femoral fractures
• No dysplasia with a sharp femoral neck
• ASA classification <3
• Pregnancy

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
After 5 years, the following shall also be measured and evaluated:<br>• A retrospective analysis of the X-rays using EBRA-FCA for the evaluation of the stem migration. <br>• According to the evaluation of the Gruen Zones early loosening of the implants should be detected as soon as possible and evaluated. <br>• Systematic collection of possible complications. <br>

Secondary Outcome Measures

Name	Time	Method
The Harris Hip Score (HHS) and the SF36 are the secondary final point of the study. The follow-ups shall be performed after 6–12 weeks, 1 year, 2 years and 5 years.