The Metaphyseal Hip Prosthesis - Total Hip

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Safety and Efficiency of the Metaphyseal Hip Prosthesis - Total Hip Arthroplasty

Conditions
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Osteoarthritis of the Hip

Intervention / Treatment
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* Device: Metaphyseal Hip Prosthesis
* Device: Stanmore


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stanmore<br>25 patients will have the Stanmore prosthesis | Device: Stanmore<br>* Stanmore hip prosthesis<br>* Other names: Stanmore hip prosthesis;|
| Experimental: Metaphyseal Hip Prosthesis<br>25 patients will have the Metaphyseal Hip Prosthesis (MHP) prosthesis | Device: Metaphyseal Hip Prosthesis<br>* Metaphyseal Hip Prosthesis (MHP) hip replacement<br>* Other names: The Metaphyseal Hip Prosthesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months, 6 months, 1 year and 2 years postoperatively | 
| RSA Translation Y | Stem movement along the y-axis in mm. (measured with RSA) | 3 months, 6 months, 1 year and 2 years postoperatively | 
| RSA Translation Z | Stem movement along z-axis in mm (measured with RSA) | 3 months, 6 months, 1 year and 2 years postoperatively | 
| RSA Rotation X | Stem Rotation around X-axis in degrees (measured with RSA) | 3 months, 6 months, 1 year and 2 years postoperatively | 
| RSA Rotation Y | Stem rotation around the y-axis in degrees ( measured with RSA) | 3 months, 6 months, 1 year and 2 years postoperatively | 
| RSA Rotation Z | Stem rotation around the z-axis in degrees (measured with RSA) | 3 months, 6 months, 1 year and 2 years postoperatively | 
| RSA MTMP | Maximum Total Point Motion (MTPM) measured with RSA. This is a mean for the total migration of the stem. | 3 months, 6 months, 1 year and 2 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Reported Device Related Complications | Safety: - Frequency of serious device related complications. | 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively | 
| 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) | pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively | 
| DEXA | Efficacy: Bone density measured using DEXA | 10 years postoperative | 
| 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. | pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively | 
| 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. | pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively | 
| 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. | pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively | 
| 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. | pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively | 
| 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. | pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively | 
| 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. | pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively | 
| 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. | pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively | 
| 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. | pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively | 
| 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. | pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively | 
| 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. | pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis