The Metaphyseal Hip Prosthesis - Total Hip

Osteoarthritis of the Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501955
• Other study ID #: BMETEU.CR.EU88 MHP
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: December 2023

Study information

• Verified date: March 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Hip
• Osteoarthritis, Hip

Intervention

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

Locations

Country	Name	City	State
Netherlands	Bravis Ziekenhuis Roosendaal	Roosendaal

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	RSA Translation Y	Stem movement along the y-axis in mm. (measured with RSA)	3 months, 6 months, 1 year and 2 years postoperatively
Primary	RSA Translation Z	Stem movement along z-axis in mm (measured with RSA)	3 months, 6 months, 1 year and 2 years postoperatively
Primary	RSA Rotation X	Stem Rotation around X-axis in degrees (measured with RSA)	3 months, 6 months, 1 year and 2 years postoperatively
Primary	RSA Rotation Y	Stem rotation around the y-axis in degrees ( measured with RSA)	3 months, 6 months, 1 year and 2 years postoperatively
Primary	RSA Rotation Z	Stem rotation around the z-axis in degrees (measured with RSA)	3 months, 6 months, 1 year and 2 years postoperatively
Primary	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	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
Secondary	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
Secondary	DEXA	Efficacy: Bone density measured using DEXA	10 years postoperative
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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