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The Metaphyseal Hip Prosthesis - Total Hip

This study is currently recruiting participants.
Verified May 2013 by Biomet, Inc.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01501955
First received: August 26, 2011
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention
Osteoarthritis of the Hip
 Device: Metaphyseal Hip Prosthesis
Device: Stanmore hip prosthesis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficiency of the Metaphyseal Hip Prosthesis - Total Hip Arthroplasty

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Radiostereometric Analysis (RSA) [ Time Frame: 24 months postoperative ] [ Designated as safety issue: No ]
    The short term stability (stem position) of the Metaphyseal Hip Prosthesis (MHP) will be analysed using Radiostereometric Analysis (RSA) to predict the long term survival.


Secondary Outcome Measures:
  • Device related complications [ Time Frame: 10 years postoperative ] [ Designated as safety issue: Yes ]

    Safety:

    - Frequency of serious device related complications.


  • Harris Hip Score & Hip Osteoarthritis Outcome Score [ Time Frame: 10 years postoperative ] [ Designated as safety issue: Yes ]

    Efficacy:

    Funcional outcome measured with HHS and HOOS


  • DEXA [ Time Frame: 10 years postoperative ] [ Designated as safety issue: Yes ]

    Efficacy:

    Bone density measured using DEXA


  • SF-12 [ Time Frame: 10 years postoperative ] [ Designated as safety issue: Yes ]

    Efficacy:

    Quality of life measured with SF-12



Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stanmore
25 patients will have the Stanmore prosthesis
 Device: Stanmore hip prosthesis
Stanmore hip prosthesis
Other Name: Stanmore hip prosthesis
Experimental: Metaphyseal Hip Prosthesis
25 patients will have the Metaphyseal Hip Prosthesis (MHP) prosthesis
 Device: Metaphyseal Hip Prosthesis
Metaphyseal Hip Prosthesis (MHP) hip replacement
Other Name: The Metaphyseal Hip Prosthesis

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).

Bone remodeling will be analyzed at 10 years using DEXA 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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501955

Contacts
Contact: EL Hoffman, Dr 165-588449 ext +31 ehoffman@fzr.nl

Locations
Netherlands
Franciscus Ziekenhuis Roosendaal Recruiting
Roosendaal, Netherlands, 4708
Contact: EL HOFFMAN, Dr     165-588449 ext +31     ehoffman@fzr.nl    
Sponsors and Collaborators
Biomet, Inc.
Investigators
Principal Investigator: EL Hoffman, Dr Franciscus Ziekenhuis Roosendaal
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01501955     History of Changes
Other Study ID Numbers: EU88 MHP
Study First Received: August 26, 2011
Last Updated: May 14, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Biomet, Inc.:
Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013