Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Corail Prosthesis With or Without Collar Design

November 10, 2016 updated by: Jens Vanbiervliet, ZOL
Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Corail prosthesis with or without collar design. Randomized study design focusing on radiolucent lines on standard x-ray.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary THA

Exclusion Criteria:

  • fractured hips

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: THA with Collar
Device: Corail with collar.
ACTIVE_COMPARATOR: THA without Collar
Device: Corail without collar.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The investigators will measure radiolucent lines on X-ray.
Time Frame: 5 year
Hypothesis: Collar shows more radiolucent lines on xray in Gruen zone 7.
5 year

Collaborators and Investigators

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

Sponsor

ZOL

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

November 1, 2016

Primary Completion (ANTICIPATED)

November 1, 2021

Study Registration Dates

First Submitted

November 3, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (ESTIMATE)

November 9, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 11, 2016

Last Update Submitted That Met QC Criteria

November 10, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 16/073U

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.

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