NCT00804388

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

January 7, 2011

Status Verified

January 1, 2011

Enrollment Period

3.2 years

First QC Date

December 5, 2008

Last Update Submit

January 6, 2011

Conditions

Primary ArthrosisOsteoarthritis

Keywords

Vitamine EE-polyHipDegenerative joint disease

Outcome Measures

Primary Outcomes (1)

  • Measure polyethylene wear and bone mineral density between the two groups

    2 year

Study Arms (2)

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

Total hip arthroplastyPROCEDURE

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

Also known as: E-poly, Vitamine E, Hip, degenerative joint disease
12

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Primary or secondary osteoarthritis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lovisenberg Diakonale sykehus

Oslo, Norway

Location

MeSH Terms

Conditions

OsteoarthritisJoint Diseases

Interventions

Arthroplasty, Replacement, HipPapaverine

Condition Hierarchy (Ancestors)

ArthritisMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis ImplantationBenzylisoquinolinesAlkaloidsHeterocyclic CompoundsOpiate AlkaloidsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Stephan M. Røhrl, MD,PhD

    Ullevål Univeristy Hospital Norway

    STUDY CHAIR

  • Einar Lindalen, MD

    Lovisenberg Diakonale sykehus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2008

First Posted

December 8, 2008

Study Start

December 1, 2008

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

January 7, 2011

Record last verified: 2011-01

Locations

NO(1)