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The Metaphyseal Hip Prosthesis - Total Hip

NCT ID: NCT01501955

Last Updated: 2024-12-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis of the Hip

Keywords

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stanmore

25 patients will have the Stanmore prosthesis

Group Type ACTIVE_COMPARATOR

Stanmore

Intervention Type DEVICE

Stanmore hip prosthesis

Metaphyseal Hip Prosthesis

25 patients will have the Metaphyseal Hip Prosthesis (MHP) prosthesis

Group Type EXPERIMENTAL

Metaphyseal Hip Prosthesis

Intervention Type DEVICE

Metaphyseal Hip Prosthesis (MHP) hip replacement

Interventions

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Metaphyseal Hip Prosthesis

Metaphyseal Hip Prosthesis (MHP) hip replacement

Intervention Type DEVICE

Stanmore

Stanmore hip prosthesis

Intervention Type DEVICE

Other Intervention Names

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The Metaphyseal Hip Prosthesis Stanmore hip prosthesis

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stan Bell, MD

Role: PRINCIPAL_INVESTIGATOR

Bravis Ziekenhuis Roosendaal

Locations

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Bravis Ziekenhuis Roosendaal

Roosendaal, , Netherlands

Site Status

Countries

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Netherlands

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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BMETEU.CR.EU88 MHP

Identifier Type: -

Identifier Source: org_study_id