Evaluation of Predictive Factors for Ruptures of Meije Duo ™ Size 1 and 2 Femoral Stems in Hip Replacement Surgery

NCT04262713 | Completed

• 1 other identifier: ID RCB : 2018-A02841-54
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Hip Arthropathy Associated With Other Conditions

Outcome Measures

Primary Outcomes (1)

• 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)

  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)

  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.

  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

  Change from baseline weight and BMI at postoperative 4 years

Study Arms (1)

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

Other: Radiographs

Interventions

Radiographs OTHER

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)

Patients implanted with Meije duo stem size 1 or 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead

Study Sites (4)

Groupe Hospitalier Diaconesses Croix saint Simon

Paris, 75020, France

Location

Orthopedic department

Paris, 75020, France

Location

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, Île-de-France Region, 75020, France

Location

Groupe Hospitalier Dianconesses croix saint Simon

Paris, Île-de-France Region, 75020, France

Location

Related Publications (3)

• 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.

  PMID: 18161256 BACKGROUND

• Silva 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.

  PMID: 12216021 BACKGROUND

• Westerman 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.

  PMID: 29608134 RESULT

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Simon MARMOR, MD

  Groupe Hospitalier Diaconesses Croix Saint-Simon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: orthopedic surgeon

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 10, 2020
• Study Start: March 23, 2019
• Primary Completion: July 12, 2021
• Study Completion: April 11, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)