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

April 10, 2018 updated by: Dr David BIAU, Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique

Randomized Controlled Trial Comparing a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Ile De France
      • Paris, Ile De France, France, 75014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 years postop

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
intraoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at time of hospital discharge, at approximately 2 days
postoperative PMA (Postel Merle d'Aubigné) score after hospital discharge
Time Frame: 3 months, 1 year, 2 years, 5 years
PMA score
3 months, 1 year, 2 years, 5 years
postoperative Oxford hip score after hospital discharge
Time Frame: 3 months, 1 year, 2 years, 5 years
oxford hip score
3 months, 1 year, 2 years, 5 years
scar assessement
Time Frame: 3 months, 1 year, 2 years, 5 years
patient specific index
3 months, 1 year, 2 years, 5 years
hip pain
Time Frame: 3 months, 1 year, 2 years, 5 years
measurement of hip pain on a Likert scale
3 months, 1 year, 2 years, 5 years
thigh pain
Time Frame: 3 months, 1 year, 2 years, 5 years
measurement of thigh pain on a Likert scale
3 months, 1 year, 2 years, 5 years
revision of hip replacement
Time Frame: at 5 years
cumulative incidence of revision at 5 years (Cox model)
at 5 years
radiological outcome - engh score
Time Frame: 2 years
Engh score
2 years
radiological outcome - ARA (AGORA Roentgenographic Assessment) score
Time Frame: 2 years
ARA score
2 years
in hospital morphine consumption
Time Frame: postop day 1
total dose of morphine used in recovery room and until day one
postop day 1
in hospital blood transfusion
Time Frame: until discharge from hospital, at approximately 2 days
proportion of patients requiring a blood transfusion during hospitalisation
until discharge from hospital, at approximately 2 days
duration of hospital stay
Time Frame: until discharge from hospital, at approximately 2 days
length of hospitalisation in days
until discharge from hospital, at approximately 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique

Investigators

  • Principal Investigator: David BIAU, MD, Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2018

Primary Completion (Anticipated)

March 9, 2022

Study Completion (Anticipated)

March 9, 2025

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

April 10, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A03215-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe