NCT01484405

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.

Trial Health

57
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Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

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

June 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 11, 2014

Status Verified

November 1, 2014

Enrollment Period

3.4 years

First QC Date

November 30, 2011

Last Update Submit

November 10, 2014

Conditions

Femur Fracture

Keywords

surgical approach for total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • dislocation rates

    Radiographic variables: AP and lateral views of hip and pelvis

    12 months

Secondary Outcomes (1)

  • other complications

    12 months

Study Arms (2)

anterolateral approach

OTHER

surgical intervention THA anterolateral approach

Procedure: anterolateral approach

posterior approach

OTHER

surgical intervention THA posterior approach

Procedure: posterior approach

Interventions

posterior approachPROCEDURE

Surgical approach for Total Hip Arthroplasty

Also known as: Total hip Athroplasty following fracture
posterior approach
anterolateral approachPROCEDURE

anterolateral surgical approach

Also known as: Total hip Athroplasty following fracture
anterolateral approach

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tampa general Hospital

Tampa, Florida, 33606, United States

Location

St Josephs Hospital

Tampa, Florida, 33607, United States

Location

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • David Watson, MD

    Florida Orthopaedic Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2011

First Posted

December 2, 2011

Study Start

June 1, 2010

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 11, 2014

Record last verified: 2014-11

Locations

US(2)