Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip Arthroplasty

NCT00883805 | Withdrawn

• 2 other identifiers: GCRC 0163IRB# 07-08-105
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing surfaces.

Conditions

Hip Replacement; Hip Implant; Total Hip Arthroplasty; Orthopaedic Surgery

Keywords

Metal Ion Concentration; Osteolysis

Outcome Measures

Primary Outcomes (1)

• metal ion concentration in urine

  1 year post-op

Secondary Outcomes (1)

• metal ion concentration in blood

  1 year post-op

Study Arms (2)

Metal-on-Metal Articulations

Subjects will be people who have had metal-on-metal total hip arthroplasties

Biological: Blood draw; Radiation: X-Ray of Hip

Ceramic-on-Metal Articulations

Subjects will be people who have had ceramic-on-metal total hip arthroplasties

Biological: Blood draw; Radiation: X-Ray of Hip

Interventions

Blood draw BIOLOGICAL

Subjects will give blood for analysis of metal ion concentrations

Ceramic-on-Metal Articulations; Metal-on-Metal Articulations

X-Ray of Hip RADIATION

Subject will have x-ray of hip to assessment of osteolysis

Ceramic-on-Metal Articulations; Metal-on-Metal Articulations

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects enrolled will have already undergone a total hip arthroplasty with either a metal-on-metal articulation, or a ceramic-on-metal articulation.

You may qualify if:

• Subject is 40 - 80, who has undergone a top hip arthroplasty with either metal on metal or ceramic on metal articulation for a diagnosis of non-inflammatory degenerative joint disease. We will also include subjects who have had bilateral hip arthroplasties or a second arthroplasty performed since the initial surgery.
• Patient must be able to provide consent to participate

You may not qualify if:

• Diagnosis other than non-inflammatory degenerative joint disease, chronic renal insufficiency, or any systemic inflammatory condition
• Evidence of active infections
• Patients whose occupations include welding or metal working
• A second arthroplasty performed since the initial will not be exclude, but their data will be analyzed as a subpopulation
• unwillingness to comply with rehabilitation program or inability to return for follow-up visits
• Any systemic steroid therapy within 3 months of surgery
• Subjects who are pregnant

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Osteolysis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Daniel Grande, Ph.D.

  Feinstein Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director:orthopaedic research

Study Record Dates

• First Submitted: April 17, 2009
• First Posted: April 20, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2014
• Last Updated: September 17, 2015

Record last verified: 2015-09

Locations

US (1)