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

NCT ID: NCT03500926

Last Updated: 2018-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-09

Study Completion Date

2025-03-09

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized 1/1 comparison
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
implant

Study Groups

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hype standard

total hip replacement with standard femoral stem

Group Type ACTIVE_COMPARATOR

total hip replacement - standard femoral stem

Intervention Type DEVICE

total hip replacement with standard femoral stem

hype mini

total hip replacement with short uncemented femoral stem

Group Type EXPERIMENTAL

total hip replacement - short femoral stem

Intervention Type DEVICE

total hip replacement with short femoral stem

Interventions

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total hip replacement - standard femoral stem

total hip replacement with standard femoral stem

Intervention Type DEVICE

total hip replacement - short femoral stem

total hip replacement with short femoral stem

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Dr David BIAU

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David BIAU, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Hopital Cochin

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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David BIAU, MD

Role: CONTACT

+33158413037

Facility Contacts

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David J Biau, MD

Role: primary

+331 58 41 30 37

Other Identifiers

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2017-A03215-48

Identifier Type: -

Identifier Source: org_study_id

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