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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.
 
ClinicalTrials.gov Identifier: NCT01501955
Recruitment Status : Active, not recruiting
First Posted : December 30, 2011
Results First Posted : August 13, 2018
Last Update Posted : February 4, 2022
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Study Description
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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 (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.

Study Design
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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
Actual 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


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. RSA Translation X [ Time Frame: 3 months, 6 months, 1 year and 2 years postoperatively ]
    Stem movement measured with RSA (radiostereometric analysis) along the x-axis in mm. RSA is a technique to accurately measure 3D movement of the prosthesis in the bone. The movement is measured with respect to the situation directly postoperative.

  2. RSA Translation Y [ Time Frame: 3 months, 6 months, 1 year and 2 years postoperatively ]
    Stem movement along the y-axis in mm. (measured with RSA)

  3. RSA Translation Z [ Time Frame: 3 months, 6 months, 1 year and 2 years postoperatively ]
    Stem movement along z-axis in mm (measured with RSA)

  4. RSA Rotation X [ Time Frame: 3 months, 6 months, 1 year and 2 years postoperatively ]
    Stem Rotation around X-axis in degrees (measured with RSA)

  5. RSA Rotation Y [ Time Frame: 3 months, 6 months, 1 year and 2 years postoperatively ]
    Stem rotation around the y-axis in degrees ( measured with RSA)

  6. RSA Rotation Z [ Time Frame: 3 months, 6 months, 1 year and 2 years postoperatively ]
    Stem rotation around the z-axis in degrees (measured with RSA)

  7. RSA MTMP [ Time Frame: 3 months, 6 months, 1 year and 2 years postoperatively ]
    Maximum Total Point Motion (MTPM) measured with RSA. This is a mean for the total migration of the stem.


Secondary Outcome Measures :
  1. Number of Reported Device Related Complications [ Time Frame: 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively ]

    Safety:

    - Frequency of serious device related complications.


  2. Harris Hip Score [ Time Frame: pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively ]

    Harris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis.

    The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points)


  3. DEXA [ Time Frame: 10 years postoperative ]

    Efficacy:

    Bone density measured using DEXA


  4. HOOS-Pain Subscale [ Time Frame: pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively ]
    HOOS (Hip disability and Osteoarthritis Outcome Score) consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  5. HOOS-Symptom Subscale [ Time Frame: pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively ]
    HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  6. HOOS-ADL Subscale [ Time Frame: pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively ]
    HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  7. HOOS-Sport Subscale [ Time Frame: pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively ]
    HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  8. HOOS-QoL Subscale [ Time Frame: pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively ]
    HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  9. WOMAC Pain [ Time Frame: pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively ]
    WOMAC Score presented in Pain (range 0-20), Stiffness (range 0-8) and Function (range 0-68) component Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  10. WOMAC Stiffness [ Time Frame: pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively ]

    Western Ontario and McMaster Osteoarthritis Index (WOMAC) presented in Pain (range 0-20), Stiffness (range 0-8) and Function (range 0-68) component.

    Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.


  11. WOMAC Function [ Time Frame: pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively ]

    WOMAC Score presented in Pain (range 0-20), Stiffness (range 0-8) and Function (range 0-68) component.

    Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.


  12. SF-12 Physical Summary Score [ Time Frame: pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively ]

    12-Item Short-Form Health Survey (SF-12) presented in Physical (PS) and Mental summary (MS) scores (range 0-100).

    A zero score indicates the lowest level of health and 100 indicates the highest level of health.


  13. SF-12 Mental Summary Score [ Time Frame: pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively ]
    SF-12 Score presented in Physical and Mental summary scores (range 0-100). A zero score indicates the lowest level of health and 100 indicates the highest level of health.


Eligibility Criteria
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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
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
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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
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Netherlands
Bravis Ziekenhuis Roosendaal
Roosendaal, Netherlands, 4708
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Principal Investigator: Stan Bell, MD Bravis Ziekenhuis Roosendaal
More Information
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01501955    
Other Study ID Numbers: BMETEU.CR.EU88 MHP
First Posted: December 30, 2011    Key Record Dates
Results First Posted: August 13, 2018
Last Update Posted: February 4, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Zimmer Biomet:
Osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases