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

Primary Purpose

Primary Arthrosis, Osteoarthritis

Status

Unknown status

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Total hip arthroplasty

About this trial

This is an interventional treatment trial for Primary Arthrosis focused on measuring Vitamine E, E-poly, Hip, Degenerative joint disease

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Lovisenberg Diakonale sykehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Uncemented total hip replacement, 32 mm caput

Uncemented total hip replacement, 36 mm caput

Outcomes

Primary Outcome Measures

Measure polyethylene wear and bone mineral density between the two groups

Secondary Outcome Measures

Full Information

NCT ID

NCT00804388

First Posted

December 5, 2008

Last Updated

January 6, 2011

Sponsor

Lovisenberg Diakonale Hospital

Collaborators

Helse Sor-Ost, Zimmer Biomet, Ullevaal University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00804388

Brief Title

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

Official Title

Comparing Polyethylene Wear Using 3. Generation Highly Crosslinked Polyethylene in an Uncemented Total Hip Prostheses With Either 32 mm or 36 mm Caput of Ceramics

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Unknown status

Study Start Date

December 2008 (undefined)

Primary Completion Date

February 2012 (Anticipated)

Study Completion Date

February 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Lovisenberg Diakonale Hospital

Collaborators

Helse Sor-Ost, Zimmer Biomet, Ullevaal University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Arthrosis, Osteoarthritis

Keywords

Vitamine E, E-poly, Hip, Degenerative joint disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Uncemented total hip replacement, 32 mm caput

Arm Title

Arm Type

Active Comparator

Arm Description

Uncemented total hip replacement, 36 mm caput

Intervention Type

Procedure

Intervention Name(s)

Total hip arthroplasty

Other Intervention Name(s)

E-poly, Vitamine E, Hip, degenerative joint disease

Intervention Description

32 mm versus 36 mm caput of ceramics Vitamin E stabilized polyethylene

Primary Outcome Measure Information:

Title

Measure polyethylene wear and bone mineral density between the two groups

Time Frame

2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephan M. Røhrl, MD,PhD

Organizational Affiliation

Ullevål Univeristy Hospital Norway

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Einar Lindalen, MD

Organizational Affiliation

Lovisenberg Diakonale sykehus

Official's Role

Study Chair

Facility Information:

Facility Name

Lovisenberg Diakonale sykehus

City

Oslo

Country

Norway

12. IPD Sharing Statement

Learn more about this trial

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

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