NCT02960633

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Last Updated

November 11, 2016

Status Verified

November 1, 2016

Enrollment Period

5 years

First QC Date

November 3, 2016

Last Update Submit

November 10, 2016

Conditions

Coxarthritis

Outcome Measures

Primary Outcomes (1)

  • The investigators will measure radiolucent lines on X-ray.

    Hypothesis: Collar shows more radiolucent lines on xray in Gruen zone 7.

    5 year

Study Arms (2)

THA with Collar

ACTIVE COMPARATOR

THA with Collar

Device: Corail with collar.

THA without Collar

ACTIVE COMPARATOR

THA without Collar

Device: Corail without collar.

Interventions

Corail with collar.DEVICE
THA with Collar
Corail without collar.DEVICE
THA without Collar

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • primary THA

You may not qualify if:

  • fractured hips

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident orthopedic Surgery

Study Record Dates

First Submitted

November 3, 2016

First Posted

November 9, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2021

Last Updated

November 11, 2016

Record last verified: 2016-11