Serum Level of Cobalt and Chromium After Ceramic on Metal Articulation Total Hip Arthroplasty
CoM
1 other identifier
observational
228
1 country
1
Brief Summary
Primary objectives:
- 1.To measure serum metal ion levels (blood Chromium (Cr) and Cobalt (Co) ion concentration) in patients that received the Ceramic on Metal arthroplasty of hip and who have well functioning primary total hip arthroplasties during short and medium- term follow up time points.
- 2.To compare blood ion levels of patient that received COM arthroplasty with the blood ion levels of patient receiving non-COM standard total hip arthroplasty (a Metal on polyethylene or ceramic on polyethylene total hip arthroplasty) at short- term and medium-term follow up time points .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 24, 2014
CompletedFirst Posted
Study publicly available on registry
January 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedJanuary 27, 2015
January 1, 2015
1.2 years
November 24, 2014
January 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum metal ion analysis
Blood sampling will be performed 2 times during follow-up outpatient clinic visits. Second sampling is performed 3 months after first sampling.
6 months
Secondary Outcomes (6)
Wear Measure
6 months
Radiographic evaluation
6 months
WOMAC score
6 months
Harris Hip score
6 months
UCLA activity score
6 months
- +1 more secondary outcomes
Study Arms (3)
A: Ceramic on Metal THA
Subgroup A1: Consist of ceramic on metal THAs with short term follow-up (less than 2years) Subgroup A2: Consist of ceramic on metal THAs with midterm follow-up (more than 2years) Subgroup A3: Consist of bilateral ceramic on metal THAs
B: Non-Ceramic on Metal THA
Patients have THA with non COM bearing
C: Healthy subjects
Patients without any implant or systemic disease, to served as controls
Interventions
Patients have THA with ceramic on metal articulation
Patients have THA with non-ceramic on metal articulation
Eligibility Criteria
The patient population is being drawn for patients seen in the orthopedics department from (April. 2009 -December 2012) patients are selected based on implant type then further selection is based on inclusion and exclusion criteria. Exclusion criteria are specifically selected to exclude any pathologies, or environmental factors that would confound the study population. Once patients are initially selected they are contacted for participation and brought in for screening. Enrollment proceeds until enough patients have been recruited to meet statistical criteria and provide sufficient study power.
You may qualify if:
- Has signed an informed consent to this study approved by the Institutional Review Board
- Is not morbidly obese
- Is clinically qualified for THA based on physical examination and medical history
- Has non inflammatory joint disease( osteoarthritis, traumatic arthritis, avascular necrosis ,pelvic fracture, dysplastic variants)
- Does not have a previous THA or fusion of the hip
- Pre-operative Harris hip score was below 75 scores
- Has follow up period that is between 1-2yr or between 2-6yr
- Surgery was performed by minimal invasive posterior approach by the single surgeon in all groups
- Standard postoperative care and rehabilitation protocol for both groups (care providers blinded for implant type/ or not)
You may not qualify if:
- Diagnosis of inflammatory joint disease
- Any current metal hardware
- Any arthroplasty in any other joint during study follow-up period
- Pre-operative deranged levels of serum urea, creatinine
- Severe medical disability limiting ambulation
- Occupational exposure to cobalt or chromium
- If they are taking proprietary multivitamins and minerals
- Chronic steroid or immunosuppressive therapy
- Metabolic bone disease other than osteoporosis
- Has plans to relocate to other geographical area before completion of study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Guro Hospital
Seoul, KS013, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Won Yong Shon, Professor
Korea University Guro Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Won Yong Shon, Department of Orthopedic Surgery, Korea University Guro Hospital, Seoul.
Study Record Dates
First Submitted
November 24, 2014
First Posted
January 27, 2015
Study Start
February 1, 2014
Primary Completion
May 1, 2015
Study Completion
August 1, 2015
Last Updated
January 27, 2015
Record last verified: 2015-01