We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Metaphyseal Hip Prosthesis - Total Hip

This study has been terminated.
(First safety criterium not met.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01501955
First Posted: December 30, 2011
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • Radiostereometric Analysis (RSA) [ Time Frame: 24 months postoperative ]
    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 ]

    Safety:

    - Frequency of serious device related complications.


  • Harris Hip Score & Hip Osteoarthritis Outcome Score [ Time Frame: 10 years postoperative ]

    Efficacy:

    Functional outcome measured with HHS and HOOS


  • DEXA [ Time Frame: 10 years postoperative ]

    Efficacy:

    Bone density measured using DEXA


  • SF-12 [ Time Frame: 10 years postoperative ]

    Efficacy:

    Quality of life measured with SF-12



Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: December 2023
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stanmore
25 patients will have the Stanmore prosthesis
Device: Stanmore
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501955


Locations
Netherlands
Franciscus Ziekenhuis Roosendaal
Roosendaal, Netherlands, 4708
Sponsors and Collaborators
Zimmer Biomet
Investigators
Principal Investigator: C.A.M.P. Bell Franciscus Ziekenhuis Roosendaal
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01501955     History of Changes
Other Study ID Numbers: BMETEU.CR.EU88 MHP
First Submitted: August 26, 2011
First Posted: December 30, 2011
Last Update Posted: February 23, 2017
Last Verified: June 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zimmer Biomet:
Osteoarthritis

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


To Top