Wear Measurements of E-Poly in an Uncemented THA With Eit... | NCT00804388

Studies
Wear Measurements of E-Poly in an Uncemented THA With Either 32 or 36 mm Caput of Ceramics.

NCT00804388

Sponsor

Lovisenberg Diakonale Hospital

Status

Unknown status

Last Update Posted

Jan 7, 2011Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Primary Arthrosis
Osteoarthritis

Interventions

Total hip arthroplasty

Countries

Norway

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

ID	Type	Description	Link
03-2008 LDS

Status Module

Record Verification Date

Jan 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

Dec 2008

Primary Completion Date

Feb 2012Estimated

Completion Date

Feb 2012Estimated

First Submitted Date

Dec 5, 2008

First Submission Date that Met QC Criteria

Dec 5, 2008

First Posted Date

Dec 8, 2008Estimated

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

Jan 6, 2011

Last Update Posted Date

Jan 7, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Lovisenberg Diakonale HospitalOTHER

Collaborators

Name	Class
Helse Sor-Ost	OTHER_GOV
Zimmer Biomet	INDUSTRY
Ullevaal University Hospital	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

The aim of the study is to compare polyethylene wear in an uncemented total hip prosthesis with 3rd. generation highly cross-linked polyethylene with a 32 mm ceramic femoral head compared to a 36 mm ceramic head. Using X-ray, RSA and DEXA.

The polyethylene to be used is E-Poly (Biomet).

The H0 hypothesis is that there is no difference with regard to polyethylene wear and bone loss between the two groups.

Detailed Description

Uncemented THA, 32 mm or 36 mm caput of ceramics, E-Poly inserts. Measure wear with RSA, X-Ray and bone mineral density with DEXA.

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Uncemented total hip replacement, 32 mm caput	Procedure: Total hip arthroplasty
2	Active Comparator	Uncemented total hip replacement, 36 mm caput	Procedure: Total hip arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total hip arthroplasty	Procedure	32 mm versus 36 mm caput of ceramics Vitamin E stabilized polyethylene	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure polyethylene wear and bone mineral density between the two groups		2 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

50-65 years old
Primary or secondary osteoarthritis

Exclusion Criteria:

Significant anatomical divergence are excluded
Rheumatoid arthritis
Fracture sequelae
Dysplasia
Immune suppression or grave systemic illness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephan M. Røhrl, MD,PhD	Ullevål Univeristy Hospital Norway	Study Chair
Einar Lindalen, MD	Lovisenberg Diakonale sykehus	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lovisenberg Diakonale sykehus		Oslo			Norway

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis
D007592	Joint Diseases

Ancestor Terms

ID	Term
D001168	Arthritis
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019644	Arthroplasty, Replacement, Hip
D010208	Papaverine

Ancestor Terms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided