Status:
COMPLETED
The Metaphyseal Hip Prosthesis - Total Hip
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis of the Hip
Eligibility:
All Genders
55-75 years
Phase:
NA
Brief Summary
The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement.
Detailed Description
The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement at short term (1 year) and long term (10 years)....
Eligibility Criteria
Inclusion
- Candidates for a total hip replacement because of arthritis of the hip
- Patients with a good general condition
- Patients willing and able to participate in the clinical trial with a 10 years follow up and who have signed an inform consent
- Males and females
- Age between 55 and 75
- Absence or little presence of osteoporotic bone (t\>-2)
- ASA score 1 and 2
Exclusion
- Patient with co morbidities that limit the physical abilities which may negatively influence the scores. Such co morbidities can for example be cardiac insufficiency or chronic respiratory diseases.
- Severe systematic diseases such as rheumatic arthritis and SLE.
- General osteoporosis (t\<-2).
- Hormonal conditions such as Paget disease, which reduces the bone density.
- Diseases that can negatively influence the 10 years life expectancy.
- Chronic use of corticosteroids.
- Extreme overweight defined as BMI above 35.
- Active bacterial infection.
- Mental weakness which could negatively influence the postoperative recovery and influence the ability to complete pain scores and other questionnaires.
- ASA score \>2.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01501955
Start Date
October 1 2012
End Date
December 1 2023
Last Update
December 18 2024
Active Locations (1)
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1
Bravis Ziekenhuis Roosendaal
Roosendaal, Netherlands, 4708