Osteoarthritis of the HipNCT01501955

The Metaphyseal Hip Prosthesis - Total Hip

A study testing Metaphyseal Hip Prosthesis and Stanmore in people with Osteoarthritis of the Hip, run by Zimmer Biomet at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 55 to 75 years
Conditions the study is for: Osteoarthritis of the Hip
What is being tested?: Metaphyseal Hip Prosthesis and Stanmore
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteNetherlands
Study dates: Oct 2012to Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Bravis Ziekenhuis Roosendaal
Roosendaal, 4708

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Conditions: Osteoarthritis of the Hip
Being tested: Metaphyseal Hip Prosthesis, Stanmore
Keywords: Osteoarthritis
Medical subject headings: Osteoarthritis, Hip, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Metaphyseal Hip ProsthesisDevice
Also called The Metaphyseal Hip Prosthesis
Metaphyseal Hip Prosthesis (MHP) hip replacement
StanmoreDevice
Also called Stanmore hip prosthesis
Stanmore hip prosthesis

Study groups in NCT01501955
Study group	Role	What they receive
Stanmore	Active comparator	25 patients will have the Stanmore prosthesis Receives: Device: Stanmore
Metaphyseal Hip Prosthesis	Experimental	25 patients will have the Metaphyseal Hip Prosthesis (MHP) prosthesis Receives: Device: Metaphyseal Hip Prosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months, 6 months, 1 year and 2 years postoperatively
RSA Translation Y
Stem movement along the y-axis in mm. (measured with RSA)
Measured: 3 months, 6 months, 1 year and 2 years postoperatively
RSA Translation Z
Stem movement along z-axis in mm (measured with RSA)
Measured: 3 months, 6 months, 1 year and 2 years postoperatively
RSA Rotation X
Stem Rotation around X-axis in degrees (measured with RSA)
Measured: 3 months, 6 months, 1 year and 2 years postoperatively
RSA Rotation Y
Stem rotation around the y-axis in degrees ( measured with RSA)
Measured: 3 months, 6 months, 1 year and 2 years postoperatively
RSA Rotation Z
Stem rotation around the z-axis in degrees (measured with RSA)
Measured: 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.
Measured: 3 months, 6 months, 1 year and 2 years postoperatively

Secondary outcomes (10)

Number of Reported Device Related Complications
Safety:
- Frequency of serious device related complications.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Dec 2023

First posted30 Dec 2011 (estimated)
Study startOct 2012
Primary completionJan 2016
Study completionDec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoarthritis of the HipStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01501955
Sponsor's protocol ID: BMETEU.CR.EU88 MHP
Status last verified: Dec 2024
First submitted: 26 Aug 2011
Last updated: 18 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis of the Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Safety and Efficiency of the Metaphyseal Hip Prosthesis - Total Hip Arthroplasty
ClinicalTrials.gov ID: NCT01501955
Acronym / sponsor ID: BMETEU.CR.EU88 MHP
Conditions: Osteoarthritis of the Hip
Keywords: Osteoarthritis
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: Oct 2012 (actual)
Primary completion: Jan 2016 (actual)
Study completion: Dec 2023 (actual)
First posted: 30 Dec 2011 (estimated)
Results: Posted 13 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Stanmore	Active comparator	Device: Stanmore25 patients will have the Stanmore prosthesis
Metaphyseal Hip Prosthesis	Experimental	Device: Metaphyseal Hip Prosthesis25 patients will have the Metaphyseal Hip Prosthesis (MHP) prosthesis

Who may qualify

Ages: 55 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Metaphyseal Hip ProsthesisAlso: The Metaphyseal Hip ProsthesisMetaphyseal Hip Prosthesis (MHP) hip replacement	Device	Metaphyseal Hip Prosthesis
StanmoreAlso: Stanmore hip prosthesisStanmore hip prosthesis	Device	Stanmore

Primary outcome

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.

10 secondary outcomes

Number of Reported Device Related Complications
Time frame: 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, 10 years postoperatively
Harris Hip Score
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
DEXA
Time frame: 1 and 2 years postoperative
HOOS-Pain Subscale
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
HOOS-Symptom Subscale
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
HOOS-ADL Subscale
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
HOOS-Sport Subscale
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
HOOS-QoL Subscale
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1,2, 3, 4, 5, 6, 7, and 10 years postoperatively
SF-12 Physical Summary Score
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
SF-12 Mental Summary Score
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively

Results and safety

Results posted to the registry on 13 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stanmore	11	9
MHP Hip Stem	9	6

Primary outcome: RSA Translation X

Time frame: 3 months, 6 months, 1 year and 2 years postoperatively. Mean (Standard Deviation). Unit: mm

Measure	Stanmore n = 10	MHP Hip Stem n = 7
3 m postoperatively	0.05 (0.20)	0.05 (0.26)
6 m postoperatively	0.10 (0.29)	0.08 (0.35)
1 y postoperatively	0.13 (0.30)	0.08 (0.41)
2 y postoperatively	0.14 (0.42)	0.21 (0.60)

Population analysed: The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.

Primary outcome: RSA Translation Y

Time frame: 3 months, 6 months, 1 year and 2 years postoperatively. Mean (Standard Deviation). Unit: mm

Measure	Stanmore n = 10	MHP Hip Stem n = 7
3 m postoperatively	-0.25 (0.34)	-0.18 (0.22)
6 m postoperatively	-0.47 (0.50)	-0.31 (0.28)
1 y postoperatively	-0.54 (0.67)	-0.25 (0.24)
2 y postoperatively	-0.25 (0.22)	-0.29 (0.43)

Primary outcome: RSA Translation Z

Time frame: 3 months, 6 months, 1 year and 2 years postoperatively. Mean (Standard Deviation). Unit: mm

Measure	Stanmore n = 10	MHP Hip Stem n = 7
3 m postoperatively	-0.10 (0.36)	-0.08 (0.24)
6 m postoperatively	-0.23 (0.45)	-0.02 (0.19)
1 y postoperatively	-0.19 (0.23)	-0.19 (0.30)
2 y postoperatively	-0.25 (0.22)	-0.29 (0.43)

Primary outcome: RSA Rotation X

Time frame: 3 months, 6 months, 1 year and 2 years postoperatively. Mean (Standard Deviation). Unit: mm

Measure	Stanmore n = 10	MHP Hip Stem n = 7
3 m postoperatively	-0.22 (0.68)	-0.18 (0.13)
6 m postoperatively	-0.18 (0.74)	-0.23 (1.16)
1 y postoperatively	-0.27 (0.48)	-0.44 (0.37)
2 y postoperatively	-0.42 (0.92)	-1.18 (0.36)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAE´s collected up to 10 years post/operatively. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stanmore	2 of 11 (18.2%)	2 of 11 (18.2%)	1 of 11
MHP Hip Stem	7 of 9 (77.8%)	2 of 9 (22.2%)	0 of 9

Limitations and caveats (from the sponsor): The enrollment was terminated early leading to a small number of patients available for analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Osteoarthritis of the Hip

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stan Bell, MD principal investigator

Bravis Ziekenhuis Roosendaal

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Metaphyseal Hip Prosthesis and Stanmore in people with Osteoarthritis of the Hip, run by Zimmer Biomet at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RSA Translation X (time frame: 3 months, 6 months, 1 year and 2 years postoperatively). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01501955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.