Comparison of Conventional and Large Diameter Femoral Hea... | NCT00175500

Studies
Comparison of Conventional and Large Diameter Femoral Heads for the Prevention of Hip Dislocation

NCT00175500

Sponsor

University of British Columbia

Status

Unknown status

Last Update Posted

Sep 22, 2011Estimated

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Hip Dislocation

Interventions

Large Diameter Femoral Head

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

Sep 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Apr 2009Actual

Completion Date

Dec 2012Estimated

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

Sep 20, 2011

Last Update Posted Date

Sep 22, 2011Estimated

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

About ten percent of revision hip replacements will dislocate. Although dislocation is not a life-threatening problem, it is stressful and costly and requires hospitalization to treat. Subjects who have repeated dislocations live with the constant fear of another dislocation. The purpose of this study is to test the effectiveness of a large ball prosthesis in preventing post-surgical dislocation. A large diameter ball has greater freedom of movement before it impinges; therefore, theoretically, it should not dislocate as easily.

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

400Estimated

Name	Type	Description	Arm Group Labels	Other Names
Large Diameter Femoral Head	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare the difference in dislocation rate between those receiving a large ball (36/40 mm femoral head) versus those receiving a 32 mm femoral head in patients who undergo revision hip arthroplasty		at two years

Secondary Outcomes

Measure	Description	Time Frame
To compare polyethylene wear in the two groups
To compare the difference in functional and quality of life measures in the two groups		at 3, 12 and 24 months post surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eligible patients will be those undergoing revision hip arthroplasty, either first revision or subsequent re-revision.
Revision must require replacement of both the acetabular component and femoral component, except when revising femur only with well-fixed Trilogy socket.
The acetabular component must have a minimum outer diameter of 50 mm.
The femoral component inserted should be a Zimmer Versys™ beaded full-coated stem or Zimmer ZMR™ stem or collarless polished taper (CPT™)
Patients must be able to reply to questionnaires in either French or English.

Exclusion Criteria:

Patients who are undergoing revision for recurrent dislocation.
Revision of the acetabulum requiring structural allograft or reconstruction ring.
Revision of the acetabulum requiring the use of cemented all-polyethylene cups.
Revision of the acetabulum using a liner cemented into an existing metal shell.
Intra-operative decision to use a constrained liner.

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
Donald Garbuz, 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
D006617	Hip Dislocation

Ancestor Terms

ID	Term
D004204	Joint Dislocations
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided