Study of Two Surgical Approaches for Total Hip Arthroplasty | NCT00881998

Studies
Study of Two Surgical Approaches for Total Hip Arthroplasty

NCT00881998

Sponsor

Rothman Institute Orthopaedics

Status

Completed

Last Update Posted

Apr 16, 2009Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Total Hip Arthroplasty

Interventions

Minimally Invasive Total Hip Arthroplasty
Conventional Total Hip Arthroplasty

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 14, 2009

First Submission Date that Met QC Criteria

Apr 15, 2009

First Posted Date

Apr 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2009

Last Update Posted Date

Apr 16, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A prospective, comparative, randomized single surgeon study comparing minimally invasive total hip arthroplasty (MIS) via anterior approach to conventional total hip arthroplasty via anterolateral transgluteal approach.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Minimally invasive total hip arthroplasty	Procedure: Minimally Invasive Total Hip Arthroplasty
2	Active Comparator		Procedure: Conventional Total Hip Arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Minimally Invasive Total Hip Arthroplasty	Procedure		1
Conventional Total Hip Arthroplasty

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with osteoarthritis of the hip and have decided to undergo total hip arthroplasty
Patients willing to sign the consent form

Exclusion Criteria:

Patient is unwilling to sign the consent form
Patient is involved in another study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Hozack, MD	Rothman Institute Orthopaedics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rothman Institute Orthorpaedics		Philadelphia	Pennsylvania	19107	United States