Hip Arthropathy Associated With Other ConditionsMEIJENCT04262713
Evaluation of Predictive Factors for Ruptures of Meije Duo ™ Size 1 and 2 Femoral Stems in Hip Replacement Surgery
A study testing Radiographs in people with Hip Arthropathy Associated With Other Conditions, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 4 sites in France.
Trial summary
A normative development concerning the mechanical resistance tests of the the femoral stems led to contraindicate, in September 2014, to implant Meije Duo ™ femoral stems size 1 or 2 in patients weighing more than 60 kg due to an assumed risk of femoral stem breakage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthropathy Associated With Other Conditions
- What is being tested?
- Radiographs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 4 sitesFrance
- Study dates
- 23 Mar 2019to 11 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An x-ray of the hip concerned will be performed on all consenting patients, having at least one criterion of the following three during their medical history since the implantation of the hip prosthesis.
- Weight> 60 kg
- DEVANE score ≥ 4
- Long neck / varus
Who cannot join
- The patient expresses his opposition to the use of his personal data
- Patients (<18 years old)
- Patients unable or out of state to express their consent
- Patient unable to speak French
- Patient with memory impairment or cognitive impairment
- Patient not affiliated to a social security or equivalent health coverage
Trial locations and contacts
4 sites in 1 country.
France4 sites
Groupe Hospitalier Diaconesses Croix saint Simon
Paris, 75020
Orthopedic department
Paris, 75020
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, Île-de-France Region, 75020
Groupe Hospitalier Dianconesses croix saint Simon
Paris, Île-de-France Region, 75020
About this study
A normative development concerning the mechanical resistance tests of the the femoral stems led to contraindicate, in September 2014, to implant Meije Duo ™ femoral stems size 1 or 2 in patients weighing more than 60 kg due to an assumed risk of femoral stem breakage.
This contraindication is based on standardized mechanical tests which may have not taken into account the changes in patient weight that may occur after the intervention.
To date, investigators have not been aware of any Meije Duo ™ size 1/2 brakeage in our patients implanted with this type of prosthesis regardless of their weights before 2014. However, it is possible that some of them have had a prostheses failure and consulted another hospital. In the absence of a clinical study on this problem, investigators decided to set up a health care assessment study collecting retrospective and prospective information from our patients.
Read the detailed description
First, patients with Meije Duo ™sizes 1 or 2, who had surgery from 2007 to 2014, will be preselected on medical records.
The information notice will be sent to them by post. A period of reflection will be respected before contacting the patient to answer their questions concerning the research and its progress and obtain their oral consent to participate in the study.
After obtaining consent, investigators will enter the retrospective data collected in the medical and prospective file collected during this call.
Patients with at least one of the following criteria: weight> 60 kg and / or long neck / varus and / or DEVANE score ≥ 4, will be selected to have a hip X-ray which will be specially scheduled for the study.
This examination will tell us about the state of the prosthesis and of the underlying bone (broken stem, loosening of the implant, bone fracture, dislocation, border, etc.
It can be performed in our radiology department of the Diaconesses Croix Saint Simon hospital group or in another radiological center chosen by the patient if the latter cannot come to our hospital. In this case, a prescription for a hip X-ray will be sent to him by post to his current address as well as an information letter intended for the radiology office.
The patients who will be included in the study are implanted with Meije Duo ™ 1 and 2 between 2007 to 2014 and will all have a minimum follow-up of 4 years from the date of implantation. The maximum number of rupture complications is observed between the fourth and the eleventh year after fitting the prosthesis. All participants will therefore have a minimum of hindsight required for the evaluation of stem breaks. All of our patients will be contacted by telephone during the study period in chronological order of their previous management for obtaining consent, prospective data and for scheduling the hip radiography according to the criteria mentioned above.
- Being tested
- Radiographs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiographsOther
Radiographs of the implanted hip with Meije duo size1 or 2 are performed in eligible patients ( Weigh>60, Long neck stem, Varus; DEVANE score ≥ 4)
| Study group | Role | What they receive |
|---|---|---|
| Patients implanted with Meije duo stem size 1 or 2 | Other | Among this arm, patients that meet criteria ( weight>
60kg and / or a long neck / varus and / or a DEVANE score ≥ 4 ) will perform hip X ray Receives: Other: Radiographs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pourcentage of participants who had stem (Meije DuoTM size 1 or 2) breakage occured between implantation and the study follow-up call phone.
The number of stem breakage that occured since prostheses implantation will be collected by asking every participant during the follow-up call phone and performing hip xray to eligible ones (see above)
Measured: Up to 4 weeks, starting from the call phone (patient consent)
Secondary outcomes (3)
Pourcentage of participants who had other prostheses failures (loosening of the prosthesis, femoral fracture, dislocation)
The number of prostheses failures that occured since the implantation will be collected by asking every participant during the follow-up call phone and by performing hip xray to eligible ones (see above)
Measured: Up to 4 weeks, starting from the call phone (patient consent)
The change of physical activity in participants from baseline (prostheses implantation) to study call-phone point time.
With DEVANE questionnaire, investigator will assess physical activity of participants
Measured: Change from baseline Devane score at postoperative 4 years
The change of the weight and the body mass index (BMI) of the patients after the implantation of Meije DuoTM rods size 1 or 2
Preoperative weight and BMI of particpantS will be collected from the medical file and postopeartive weight and BMI during follow up call phone
Measured: Change from baseline weight and BMI at postoperative 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start23 Mar 2019
- Primary completion12 Jul 2021
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hip Arthropathy Associated With Other ConditionsStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SMARMOR, Groupe Hospitalier Diaconesses Croix Saint-Simon
- Investigators
- Simon MARMOR, MD, Principal investigator, Groupe Hospitalier Diaconesses Croix Saint-Simon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262713
- Sponsor's protocol ID
- ID RCB : 2018-A02841-54
- Acronym
- MEIJE
- Status last verified
- Mar 2023
- First submitted
- 4 Feb 2020
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wroblewski BM, Siney PD, Fleming PA. Increasing patients' body mass. Are the criteria for testing stemmed femoral components in total hip arthroplasty still valid? Proc Inst Mech Eng H. 2007 Nov;221(8):959-61. doi: 10.1243/09544119JEIM305.
PubMed 18161256Silva M, Shepherd EF, Jackson WO, Dorey FJ, Schmalzried TP. Average patient walking activity approaches 2 million cycles per year: pedometers under-record walking activity. J Arthroplasty. 2002 Sep;17(6):693-7. doi: 10.1054/arth.2002.32699.
PubMed 12216021Westerman AP, Moor AR, Stone MH, Stewart TD. Hip stem fatigue: : The implications of increasing patient mass. Proc Inst Mech Eng H. 2018 May;232(5):520-530. doi: 10.1177/0954411918767200. Epub 2018 Apr 2.
PubMed 29608134
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Predictive Factors for Ruptures of Meije Duo ™ Size 1 and 2 Femoral Stems in Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT04262713
- Acronym / sponsor ID
- MEIJE / ID RCB : 2018-A02841-54
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- 23 Mar 2019 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A normative development concerning the mechanical resistance tests of the the femoral stems led to contraindicate, in September 2014, to implant Meije Duo ™ femoral stems size 1 or 2 in patients weighing more than 60 kg due to an assumed risk of femoral stem breakage.
This contraindication is based on standardized mechanical tests which may have not taken into account the changes in patient weight that may occur after the intervention.
To date, investigators have not been aware of any Meije Duo ™ size 1/2 brakeage in our patients implanted with this type of prosthesis regardless of their weights before 2014. However, it is possible that some of them have had a prostheses failure and consulted another hospital. In the absence of a clinical study on this problem, investigators decided to set up a health care assessment study collecting retrospective and prospective information from our patients.
Detailed description
First, patients with Meije Duo ™sizes 1 or 2, who had surgery from 2007 to 2014, will be preselected on medical records.
The information notice will be sent to them by post. A period of reflection will be respected before contacting the patient to answer their questions concerning the research and its progress and obtain their oral consent to participate in the study.
After obtaining consent, investigators will enter the retrospective data collected in the medical and prospective file collected during this call.
Patients with at least one of the following criteria: weight> 60 kg and / or long neck / varus and / or DEVANE score ≥ 4, will be selected to have a hip X-ray which will be specially scheduled for the study.
This examination will tell us about the state of the prosthesis and of the underlying bone (broken stem, loosening of the implant, bone fracture, dislocation, border, etc.
It can be performed in our radiology department of the Diaconesses Croix Saint Simon hospital group or in another radiological center chosen by the patient if the latter cannot come to our hospital. In this case, a prescription for a hip X-ray will be sent to him by post to his current address as well as an information letter intended for the radiology office.
The patients who will be included in the study are implanted with Meije Duo ™ 1 and 2 between 2007 to 2014 and will all have a minimum follow-up of 4 years from the date of implantation. The maximum number of rupture complications is observed between the fourth and the eleventh year after fitting the prosthesis. All participants will therefore have a minimum of hindsight required for the evaluation of stem breaks. All of our patients will be contacted by telephone during the study period in chronological order of their previous management for obtaining consent, prospective data and for scheduling the hip radiography according to the criteria mentioned above.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients implanted with Meije duo stem size 1 or 2 | Other | Other: RadiographsAmong this arm, patients that meet criteria ( weight> 60kg and / or a long neck / varus and / or a DEVANE score ≥ 4 ) will perform hip X ray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- An x-ray of the hip concerned will be performed on all consenting patients, having at least one criterion of the following three during their medical history since the implantation of the hip prosthesis.
- Weight> 60 kg
- DEVANE score ≥ 4
- Long neck / varus
Key exclusion criteria (6 listed)
- The patient expresses his opposition to the use of his personal data
- Patients (<18 years old)
- Patients unable or out of state to express their consent
- Patient unable to speak French
- Patient with memory impairment or cognitive impairment
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 |
|---|---|---|
| RadiographsRadiographs of the implanted hip with Meije duo size1 or 2 are performed in eligible patients ( Weigh>60, Long neck stem, Varus; DEVANE score ≥ 4) | Other | Patients implanted with Meije duo stem size 1 or 2 |
Primary outcome
Pourcentage of participants who had stem (Meije DuoTM size 1 or 2) breakage occured between implantation and the study follow-up call phone.
Time frame: Up to 4 weeks, starting from the call phone (patient consent)
The number of stem breakage that occured since prostheses implantation will be collected by asking every participant during the follow-up call phone and performing hip xray to eligible ones (see above)
3 secondary outcomes
Pourcentage of participants who had other prostheses failures (loosening of the prosthesis, femoral fracture, dislocation)
Time frame: Up to 4 weeks, starting from the call phone (patient consent)
The change of physical activity in participants from baseline (prostheses implantation) to study call-phone point time.
Time frame: Change from baseline Devane score at postoperative 4 years
The change of the weight and the body mass index (BMI) of the patients after the implantation of Meije DuoTM rods size 1 or 2
Time frame: Change from baseline weight and BMI at postoperative 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Background: PubMed 18161256Wroblewski BM, Siney PD, Fleming PA. Increasing patients' body mass. Are the criteria for testing stemmed femoral components in total hip arthroplasty still valid? Proc Inst Mech Eng H. 2007 Nov;221(8):959-61. doi: 10.1243/09544119JEIM305.
- Background: PubMed 12216021Silva M, Shepherd EF, Jackson WO, Dorey FJ, Schmalzried TP. Average patient walking activity approaches 2 million cycles per year: pedometers under-record walking activity. J Arthroplasty. 2002 Sep;17(6):693-7. doi: 10.1054/arth.2002.32699.
- Results publication: PubMed 29608134Westerman AP, Moor AR, Stone MH, Stewart TD. Hip stem fatigue: : The implications of increasing patient mass. Proc Inst Mech Eng H. 2018 May;232(5):520-530. doi: 10.1177/0954411918767200. Epub 2018 Apr 2.
- Individual participant dataSharing planned: No
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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.
Simon MARMOR, MD principal investigator
Groupe Hospitalier Diaconesses Croix Saint-Simon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiographs in people with Hip Arthropathy Associated With Other Conditions, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 4 sites in France.
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 4 inclusion and 6 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 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pourcentage of participants who had stem (Meije DuoTM size 1 or 2) breakage occured between implantation and the study follow-up call phone. (time frame: Up to 4 weeks, starting from the call phone (patient consent)). 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 NCT04262713, which also lists 3 linked publications.
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 23 Mar 2023.