Anterolateral Versus Posterior Approach for Total Hip Art... | NCT01484405

Studies
Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture

NCT01484405

Sponsor

Florida Orthopaedic Institute

Status

Terminated

Last Update Posted

Nov 11, 2014Estimated

Enrollment

16Actual

Phase

Not Applicable

Conditions

Femur Fracture

Interventions

posterior approach
anterolateral approach

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

Nov 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low enrollment.

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Nov 30, 2011

First Submission Date that Met QC Criteria

Dec 1, 2011

First Posted Date

Dec 2, 2011Estimated

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

Nov 10, 2014

Last Update Posted Date

Nov 11, 2014Estimated

Name	Class
Orthopaedic Trauma Association	OTHER

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

There are two surgical approaches (incision types) used by surgeons who do total hip replacements. The purpose of this study is to determine which type of surgical approach (incision type) produces the best results for patients who have a total hip replacement.

Null Hypothesis : There is no difference in complication rate, functional outcome, surgical time, or blood loss when comparing outcomes in patients receiving THA to hemiarthroplasty or ORIF for femoral neck fractures.

Detailed Description

Patients undergoing Total hip Arthroplasty following displaced femoral neck fracture, will be consented and randomized to one of two surgical approaches ( anterior or posterior).

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

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
anterolateral approach	Other	surgical intervention THA anterolateral approach	Procedure: anterolateral approach
posterior approach	Other	surgical intervention THA posterior approach	Procedure: posterior approach

Interventions

Name	Type	Description	Arm Group Labels	Other Names
posterior approach	Procedure	Surgical approach for Total Hip Arthroplasty	posterior approach

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
dislocation rates	Radiographic variables: AP and lateral views of hip and pelvis	12 months

Secondary Outcomes

Measure	Description	Time Frame
other complications	Hospital readmission, reoperation	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Displaced femoral neck fracture
Age 65 years or older
Acute, femoral neck fracture

Exclusion Criteria:

Cognitive impairment

Active Infection
Limited functional capacity (nursing home resident, non-ambulatory, severe cardiorespiratory disease)
Limited life expectancy
Pathologic fracture (tumor)
Acetabular fractures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Watson, MD	Florida Orthopaedic Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampa general Hospital		Tampa	Florida	33606	United States
St Josephs Hospital

Condition Browse Module

MeSH Terms

ID	Term
D005264	Femoral Fractures

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D007869	Leg Injuries

Browse Leaves

Not provided

Browse Branches

Not provided