NCT00757354

Brief Summary

A clinical Evaluation to determine metal ion release from 4th generation metal-on-metal hip articulating surfaces in cementless total hip arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

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

First Submitted

Initial submission to the registry

September 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
3.7 years until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 19, 2017

Status Verified

June 1, 2017

Enrollment Period

1.7 years

First QC Date

September 22, 2008

Last Update Submit

June 16, 2017

Conditions

OsteoarthritisAvascular NecrosisTraumatic ArthritisRheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • concentration of Cobalt, Chromium and Molybdenum ions in urine

    various follow-up visits

Secondary Outcomes (1)

  • harris Hip Score, oxford hip, WOMAC and SF-12

    various follow-up visits

Study Arms (1)

Metal on Metal cementless hip

EXPERIMENTAL

Metal on Metal cementless hip arthroplasty

Procedure: Metal on Metal cementless hip

Interventions

Metal on Metal cementless hipPROCEDURE

Metal on Metal hip arthroplasty

Also known as: metal on metal hip arthroplasty
Metal on Metal cementless hip

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects selected for this Evaluation will be grouped by initial diagnosis into one of the following diagnostic groups:
  • Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and traumatic arthritis.
  • Rheumatoid arthritis.
  • Selection of subjects for this Evaluation should include the following considerations:
  • Patients under 70 years of age.
  • Willing to return for follow-up evaluations.
  • No bias to sex.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avon Orthopaedic Centre

Bristol, United Kingdom

Location

MeSH Terms

Conditions

OsteoarthritisOsteonecrosisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Evert J Smith, FRCS

    Avon Orthopaedic Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2008

First Posted

September 23, 2008

Study Start

June 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

June 19, 2017

Record last verified: 2017-06

Locations

GB(1)