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

Primary Purpose

Osteoarthritis, Hip

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
total hip replacement - standard femoral stem
total hip replacement - short femoral stem
Sponsored by
Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital CochinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

hype standard

hype mini

Arm Description

total hip replacement with standard femoral stem

total hip replacement with short uncemented femoral stem

Outcomes

Primary Outcome Measures

stem subsidence
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

Intraoperative surgeon satisfaction
measurement of surgeon's satisfaction with using the instrumentation to insert the stem; on a Likert scale intraoperative complication

Full Information

First Posted
March 9, 2018
Last Updated
April 10, 2018
Sponsor
Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
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1. Study Identification

Unique Protocol Identification Number
NCT03500926
Brief Title
Comparison of a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem
Acronym
hype
Official Title
Randomized Controlled Trial Comparing a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2018 (Actual)
Primary Completion Date
March 9, 2022 (Anticipated)
Study Completion Date
March 9, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized 1/1 comparison
Masking
Participant
Masking Description
implant
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hype standard
Arm Type
Active Comparator
Arm Description
total hip replacement with standard femoral stem
Arm Title
hype mini
Arm Type
Experimental
Arm Description
total hip replacement with short uncemented femoral stem
Intervention Type
Device
Intervention Name(s)
total hip replacement - standard femoral stem
Intervention Description
total hip replacement with standard femoral stem
Intervention Type
Device
Intervention Name(s)
total hip replacement - short femoral stem
Intervention Description
total hip replacement with short femoral stem
Primary Outcome Measure Information:
Title
stem subsidence
Description
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)
Time Frame
2 years postop
Secondary Outcome Measure Information:
Title
Intraoperative surgeon satisfaction
Description
measurement of surgeon's satisfaction with using the instrumentation to insert the stem; on a Likert scale intraoperative complication
Time Frame
intraoperative
Other Pre-specified Outcome Measures:
Title
intraoperative proportion of patients requiring a blood transfusion
Description
proportion of patients requiring a blood transfusion during the procedure
Time Frame
at time of hospital discharge, at approximately 2 days
Title
postoperative PMA (Postel Merle d'Aubigné) score after hospital discharge
Description
PMA score
Time Frame
3 months, 1 year, 2 years, 5 years
Title
postoperative Oxford hip score after hospital discharge
Description
oxford hip score
Time Frame
3 months, 1 year, 2 years, 5 years
Title
scar assessement
Description
patient specific index
Time Frame
3 months, 1 year, 2 years, 5 years
Title
hip pain
Description
measurement of hip pain on a Likert scale
Time Frame
3 months, 1 year, 2 years, 5 years
Title
thigh pain
Description
measurement of thigh pain on a Likert scale
Time Frame
3 months, 1 year, 2 years, 5 years
Title
revision of hip replacement
Description
cumulative incidence of revision at 5 years (Cox model)
Time Frame
at 5 years
Title
radiological outcome - engh score
Description
Engh score
Time Frame
2 years
Title
radiological outcome - ARA (AGORA Roentgenographic Assessment) score
Description
ARA score
Time Frame
2 years
Title
in hospital morphine consumption
Description
total dose of morphine used in recovery room and until day one
Time Frame
postop day 1
Title
in hospital blood transfusion
Description
proportion of patients requiring a blood transfusion during hospitalisation
Time Frame
until discharge from hospital, at approximately 2 days
Title
duration of hospital stay
Description
length of hospitalisation in days
Time Frame
until discharge from hospital, at approximately 2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David BIAU, MD
Phone
+33158413037
Email
secretatiat.biau.cch@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David BIAU, MD
Organizational Affiliation
Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Cochin
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David J Biau, MD
Phone
+331 58 41 30 37
Email
secretariat.biau.cch@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Comparison of a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem

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