The Metaphyseal Hip Prosthesis – Total Hip

Overview

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

Full Title of Study: “Evaluation of the Safety and Efficiency of the Metaphyseal Hip Prosthesis – Total Hip Arthroplasty”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2016

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.

Interventions

  • Device: Metaphyseal Hip Prosthesis
    • Metaphyseal Hip Prosthesis (MHP) hip replacement
  • Device: Stanmore
    • Stanmore hip prosthesis

Arms, Groups and Cohorts

  • Active Comparator: Stanmore
    • 25 patients will have the Stanmore prosthesis
  • Experimental: Metaphyseal Hip Prosthesis
    • 25 patients will have the Metaphyseal Hip Prosthesis (MHP) prosthesis

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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 Measures

  • 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.
  • 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)
  • DEXA
    • Time Frame: 10 years postoperative
    • Efficacy: Bone density measured using DEXA
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zimmer Biomet
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Stan Bell, MD, Principal Investigator, Bravis Ziekenhuis Roosendaal

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