The Metaphyseal Hip Prosthesis - Total Hip

This study has suspended participant recruitment.
(First safety criterium not met. Awaiting further follow up data.)
Information provided by (Responsible Party):
Biomet, Inc. Identifier:
First received: August 26, 2011
Last updated: June 24, 2015
Last verified: June 2014
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
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:

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 ]


    - Frequency of serious device related complications.

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


    Funcional outcome measured with HHS and HOOS

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


    Bone density measured using DEXA

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


    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
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.


Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01501955

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

Responsible Party: Biomet, Inc. Identifier: NCT01501955     History of Changes
Other Study ID Numbers: BMETEU.CR.EU88 MHP 
Study First Received: August 26, 2011
Last Updated: June 24, 2015
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Ministry of Health, Welfare and Sport

Keywords provided by Biomet, Inc.:

Additional relevant MeSH terms:
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on May 30, 2016