Comparison of Two Minimally Invasive Surgical Techniques... | NCT00175461

Studies
Comparison of Two Minimally Invasive Surgical Techniques for Hip Replacement

NCT00175461

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Mar 3, 2017Actual

Enrollment

156Actual

Phase

Phase 1

Conditions

Osteoarthritis

Interventions

hip surgery

Countries

Canada

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

Mar 2017

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

Sep 2005

Primary Completion Date

Apr 2009Actual

Completion Date

Aug 31, 2011Actual

First Submitted Date

Sep 11, 2005

First Submission Date that Met QC Criteria

Sep 11, 2005

First Posted Date

Sep 15, 2005Estimated

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

Mar 1, 2017

Last Update Posted Date

Mar 3, 2017Actual

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

Comparison of the clinical effectiveness and cost-effectiveness of the MIS anterolateral approach (MIS Watson Jones, G3) versus anterolateral mini or posterolateral mini approaches in primary total hip arthroplasty

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

156Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hip surgery	Procedure	Comparison of the clinical effectiveness and cost-effectiveness of the MIS anterolateral approach (MIS Watson Jones, G3) versus anterolateral mini or posterolateral mini approaches in primary total hip arthroplasty

Measure	Description	Time Frame
3-months WOMAC score		3 months

Measure	Description	Time Frame
Cost-effectiveness at 2-years		Two years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

No contralateral hip symptoms, no major comorbidity

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nelson Greidanus, MD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vancouver General Hospital		Vancouver	British Columbia	V5Z 1L8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided