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Comparison of a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem (hype)

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ClinicalTrials.gov Identifier: NCT03500926
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dr David BIAU, Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique

Study Description
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Brief Summary:
This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Device: total hip replacement - standard femoral stem Device: total hip replacement - short femoral stem Not Applicable

Detailed Description:

This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.

Patients will be randomized a few days before the operation. At the time of surgery, the surgeon will use the relevant implant. Patients will be followed up for 5 years after surgery. The main outcome criteria is the stem subsidence measured radiographically with a dedicated software.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized 1/1 comparison
Masking: Single (Participant)
Masking Description: implant
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem
Actual Study Start Date : March 9, 2018
Estimated Primary Completion Date : March 9, 2022
Estimated Study Completion Date : March 9, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: hype standard
total hip replacement with standard femoral stem
 Device: total hip replacement - standard femoral stem
total hip replacement with standard femoral stem
Experimental: hype mini
total hip replacement with short uncemented femoral stem
 Device: total hip replacement - short femoral stem
total hip replacement with short femoral stem


Outcome Measures
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Primary Outcome Measures :
  1. stem subsidence [ Time Frame: 2 years postop ]
    stem subsidence will be measured using the EBRA (Ein-Bild-Rontgen-analyse) software on postoperative antero-posterior radiographs (5 xrays from day one to year 2)


Secondary Outcome Measures :
  1. Intraoperative surgeon satisfaction [ Time Frame: intraoperative ]
    measurement of surgeon's satisfaction with using the instrumentation to insert the stem; on a Likert scale intraoperative complication


Other Outcome Measures:
  1. intraoperative proportion of patients requiring a blood transfusion [ Time Frame: at time of hospital discharge, at approximately 2 days ]
    proportion of patients requiring a blood transfusion during the procedure

  2. postoperative PMA (Postel Merle d'Aubigné) score after hospital discharge [ Time Frame: 3 months, 1 year, 2 years, 5 years ]
    PMA score

  3. postoperative Oxford hip score after hospital discharge [ Time Frame: 3 months, 1 year, 2 years, 5 years ]
    oxford hip score

  4. scar assessement [ Time Frame: 3 months, 1 year, 2 years, 5 years ]
    patient specific index

  5. hip pain [ Time Frame: 3 months, 1 year, 2 years, 5 years ]
    measurement of hip pain on a Likert scale

  6. thigh pain [ Time Frame: 3 months, 1 year, 2 years, 5 years ]
    measurement of thigh pain on a Likert scale

  7. revision of hip replacement [ Time Frame: at 5 years ]
    cumulative incidence of revision at 5 years (Cox model)

  8. radiological outcome - engh score [ Time Frame: 2 years ]
    Engh score

  9. radiological outcome - ARA (AGORA Roentgenographic Assessment) score [ Time Frame: 2 years ]
    ARA score

  10. in hospital morphine consumption [ Time Frame: postop day 1 ]
    total dose of morphine used in recovery room and until day one

  11. in hospital blood transfusion [ Time Frame: until discharge from hospital, at approximately 2 days ]
    proportion of patients requiring a blood transfusion during hospitalisation

  12. duration of hospital stay [ Time Frame: until discharge from hospital, at approximately 2 days ]
    length of hospitalisation in days


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hip osteoarthritis requiring a total hip replacement
  • >18 years old
  • agrees to participate

Exclusion Criteria:

  • total hip replacement not indicated
  • general anesthesia contraindicated
  • previous surgery on the ipsilateral femur
  • follow-up not possible
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500926


Contacts
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Contact: David BIAU, MD +33158413037 secretatiat.biau.cch@aphp.fr

Locations
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France
Hopital Cochin Recruiting
Paris, Ile De France, France, 75014
Contact: David J Biau, MD    +331 58 41 30 37    secretariat.biau.cch@aphp.fr   
Sponsors and Collaborators
Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
Investigators
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Principal Investigator: David BIAU, MD Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
More Information
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Responsible Party: Dr David BIAU, Professor, Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
ClinicalTrials.gov Identifier: NCT03500926    
Other Study ID Numbers: 2017-A03215-48
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Osteoarthritis
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases