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The Metaphyseal Hip Prosthesis - Total Hip | Clinical Trials | Clareo Health

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COMPLETEDNANCT01501955

The Metaphyseal Hip Prosthesis - Total Hip

The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement.

Lead sponsor: Zimmer Biomet•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Zimmer Biomet

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). Bone remodeling will be analyzed at 10 years using DEXA (Dual Energy X-Ray Absorptiometry (bone scan test)) measurements. This is a single-center prospective study with 25 patients in the study and 25 in the control group in open Randomized Clinical Trial.

Age

55 - 75 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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 Criteria

•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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 18, 2024Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment20

Start dateOct 2012

Last updatedDec 18, 2024

Condition

Osteoarthritis of the Hip

Locations shown

Bravis Ziekenhuis Roosendaal

Roosendaal

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2024Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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