The Metaphyseal Hip Prosthesis - Total Hip

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. Identifier: NCT01501955
Recruitment Status : Terminated (First safety criterium not met.)
First Posted : December 30, 2011
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Hip Device: Metaphyseal Hip Prosthesis Device: Stanmore Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : October 2012
Actual Primary Completion Date : January 2016
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Device related complications [ Time Frame: 10 years postoperative ]


    - Frequency of serious device related complications.

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


    Functional outcome measured with HHS and HOOS

  3. DEXA [ Time Frame: 10 years postoperative ]


    Bone density measured using DEXA

  4. SF-12 [ Time Frame: 10 years postoperative ]


    Quality of life measured with SF-12

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

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 identifier (NCT number): NCT01501955

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

Responsible Party: Zimmer Biomet Identifier: NCT01501955     History of Changes
Other Study ID Numbers: BMETEU.CR.EU88 MHP
First Posted: December 30, 2011    Key Record Dates
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:

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