The Metaphyseal Hip Prosthesis - Total Hip

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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Hip
• Intervention / Treatment: Device: Stanmore; Device: 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 (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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Roosendaal, Netherlands, 4708
    • Bravis Ziekenhuis Roosendaal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stanmore; 25 patients will have the Stanmore prosthesis	Device: Stanmore; Stanmore hip prosthesis; Other Names: 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 Names: The Metaphyseal Hip Prosthesis

What is the study measuring?

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, 2, 3, 4, 5, 6, 7, 10 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, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
DEXA	Efficacy: Bone density measured using the average DEXA score in each zone. For the long Stanmore the 7 Gruen zones were defined. For the short MHP stem an adjusted model with only 5 zones was used. The scan at 6 weeks is used as the baseline measurement to analyze if the bone density changes in the following years. At 1 year and 2 year follow up, percentual change is presented for both groups with respect to the 6 weeks DEXA score	1 and 2 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, 2, 3, 4, 5, 6, 7, and 10 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, 2, 3, 4, 5, 6, 7, and 10 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, 2, 3, 4, 5, 6, 7, and 10 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, 2, 3, 4, 5, 6, 7, and 10 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, 1,2, 3, 4, 5, 6, 7, and 10 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, 2, 3, 4, 5, 6, 7, and 10 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, 2, 3, 4, 5, 6, 7, and 10 years postoperatively

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Stan Bell, MD, Bravis Ziekenhuis Roosendaal

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: August 26, 2011
• First Submitted That Met QC Criteria: December 29, 2011
• First Posted (Estimated): December 30, 2011

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Osteoarthritis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: BMETEU.CR.EU88 MHP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No