Back to resultsThe Metaphyseal Hip Prosthesis - Total Hip
Primary Purpose
Osteoarthritis of the Hip
Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Metaphyseal Hip Prosthesis
Stanmore
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Hip focused on measuring Osteoarthritis
Eligibility 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.
Sites / Locations
- Bravis Ziekenhuis Roosendaal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Stanmore
Metaphyseal Hip Prosthesis
Arm Description
25 patients will have the Stanmore prosthesis
25 patients will have the Metaphyseal Hip Prosthesis (MHP) prosthesis
Outcomes
Primary Outcome Measures
RSA Translation X
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
Stem movement along the y-axis in mm. (measured with RSA)
RSA Translation Z
Stem movement along z-axis in mm (measured with RSA)
RSA Rotation X
Stem Rotation around X-axis in degrees (measured with RSA)
RSA Rotation Y
Stem rotation around the y-axis in degrees ( measured with RSA)
RSA Rotation Z
Stem rotation around the z-axis in degrees (measured with RSA)
RSA MTMP
Maximum Total Point Motion (MTPM) measured with RSA. This is a mean for the total migration of the stem.
Secondary Outcome Measures
Number of Reported Device Related Complications
Safety:
- Frequency of serious device related complications.
Harris Hip Score
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
Efficacy:
Bone density measured using DEXA
HOOS-Pain Subscale
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
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
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
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
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
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01501955
Brief Title
The Metaphyseal Hip Prosthesis - Total Hip
Official Title
Evaluation of the Safety and Efficiency of the Metaphyseal Hip Prosthesis - Total Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2012 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Hip
Keywords
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stanmore
Arm Type
Active Comparator
Arm Description
25 patients will have the Stanmore prosthesis
Arm Title
Metaphyseal Hip Prosthesis
Arm Type
Experimental
Arm Description
25 patients will have the Metaphyseal Hip Prosthesis (MHP) prosthesis
Intervention Type
Device
Intervention Name(s)
Metaphyseal Hip Prosthesis
Other Intervention Name(s)
The Metaphyseal Hip Prosthesis
Intervention Description
Metaphyseal Hip Prosthesis (MHP) hip replacement
Intervention Type
Device
Intervention Name(s)
Stanmore
Other Intervention Name(s)
Stanmore hip prosthesis
Intervention Description
Stanmore hip prosthesis
Primary Outcome Measure Information:
Title
RSA Translation X
Description
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.
Time Frame
3 months, 6 months, 1 year and 2 years postoperatively
Title
RSA Translation Y
Description
Stem movement along the y-axis in mm. (measured with RSA)
Time Frame
3 months, 6 months, 1 year and 2 years postoperatively
Title
RSA Translation Z
Description
Stem movement along z-axis in mm (measured with RSA)
Time Frame
3 months, 6 months, 1 year and 2 years postoperatively
Title
RSA Rotation X
Description
Stem Rotation around X-axis in degrees (measured with RSA)
Time Frame
3 months, 6 months, 1 year and 2 years postoperatively
Title
RSA Rotation Y
Description
Stem rotation around the y-axis in degrees ( measured with RSA)
Time Frame
3 months, 6 months, 1 year and 2 years postoperatively
Title
RSA Rotation Z
Description
Stem rotation around the z-axis in degrees (measured with RSA)
Time Frame
3 months, 6 months, 1 year and 2 years postoperatively
Title
RSA MTMP
Description
Maximum Total Point Motion (MTPM) measured with RSA. This is a mean for the total migration of the stem.
Time Frame
3 months, 6 months, 1 year and 2 years postoperatively
Secondary Outcome Measure Information:
Title
Number of Reported Device Related Complications
Description
Safety:
- Frequency of serious device related complications.
Time Frame
6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively
Title
Harris Hip Score
Description
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)
Time Frame
pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively
Title
DEXA
Description
Efficacy:
Bone density measured using DEXA
Time Frame
10 years postoperative
Title
HOOS-Pain Subscale
Description
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.
Time Frame
pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively
Title
HOOS-Symptom Subscale
Description
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.
Time Frame
pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively
Title
HOOS-ADL Subscale
Description
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.
Time Frame
pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively
Title
HOOS-Sport Subscale
Description
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.
Time Frame
pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively
Title
HOOS-QoL Subscale
Description
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.
Time Frame
pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively
Title
WOMAC Pain
Description
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.
Time Frame
pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively
Title
WOMAC Stiffness
Description
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.
Time Frame
pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively
Title
WOMAC Function
Description
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.
Time Frame
pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively
Title
SF-12 Physical Summary Score
Description
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.
Time Frame
pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively
Title
SF-12 Mental Summary Score
Description
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.
Time Frame
pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stan Bell, MD
Organizational Affiliation
Bravis Ziekenhuis Roosendaal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bravis Ziekenhuis Roosendaal
City
Roosendaal
ZIP/Postal Code
4708
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Metaphyseal Hip Prosthesis - Total Hip
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