Functional Recovery After Partial Hip Arthroplasty: Anter... | NCT01520961

Studies
Functional Recovery After Partial Hip Arthroplasty: Anterior or Posterolateral Approach?

NCT01520961

Sponsor

Hospital Ambroise Paré Paris

Status

Completed

Last Update Posted

Feb 9, 2015Estimated

Enrollment

82Actual

Phase

Not provided

Conditions

Hip Arthroplasty
Femoral Neck Fractures

Interventions

Not provided

Countries

France

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

Feb 2015

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

Jan 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Jan 19, 2012

First Submission Date that Met QC Criteria

Jan 26, 2012

First Posted Date

Jan 30, 2012Estimated

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

Feb 6, 2015

Last Update Posted Date

Feb 9, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shahnaz Klouche, MD, Physician Responsible of Clinical Research, Hospital Ambroise Paré ParisPrincipal Investigator

Lead Sponsor

Hospital Ambroise Paré ParisOTHER

Collaborators

Not provided

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

Hueter anterior approach as described by Siguier allows an anatomical approach without muscle or tendon sections. It minimizes the rate of dislocation after primary total hip arthroplasty (1.5%, Sariali)and seems to allow quicker rehabilitation.

The investigators hypothesis was Hueter anterior approach allows quicker functional recovery after partial hip replacement.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of mobility	Efficacity issue	Timed Get Up and Go Test at six weeks

Secondary Outcomes

Measure	Description	Time Frame
Measurement of mobility		Using 2 cruches or walker at 6 weeks after surgery
Dislocation rate		At 6 weeks postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Femoral Neck Fracture
Partial Hip Arthroplasty

Exclusion Criteria:

Total Hip Arthroplasty
Osteosynthesis
Pathologic fracture

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Partial Hip Arthroplasty for Femoral Neck Fracture

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ambroise Paré Hospital. Orthopaedic surgery department		Boulogne-Billancourt	Île-de-France Region	92100	France

Condition Browse Module

MeSH Terms

ID	Term
D005265	Femoral Neck Fractures

Ancestor Terms

ID	Term
D006620	Hip Fractures
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Hueter Anterior Approach
posterolateral approach