NCT00285974

Brief Summary

Prospective study including 6 groups of 20 patients with a total hip prosthesis. Five different types of metal-on-metal prostheses are studied, and 1 group with ceramic-on-ceramic prostheses acts as control group. Patients undergo a clinical evaluation and blood sampling preoperatively, and 3, 6, 12 and 24 months postoperatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2006

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

1.9 years

First QC Date

February 1, 2006

Last Update Submit

December 6, 2022

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Concentration of metal ions in the blood

    preoperatively, and 3, 6, 12 and 24 months postoperatively.

Study Arms (1)

hip prosthesis

EXPERIMENTAL
Device: metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis

Interventions

metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesisDEVICE

metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis

hip prosthesis

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hip osteoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Rene Verdonk, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 2, 2006

Study Start

December 1, 2003

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

December 8, 2022

Record last verified: 2022-12

Locations

BE(1)