Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem
NCT ID: NCT01422564
Last Updated: 2015-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
41 participants
INTERVENTIONAL
2007-01-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Metal on Metal
Metal on Metal articulation system
Metal on Metal Hip System
Total hip arthroplasty with a metal on metal component system
HCLPC
THA using Highly Cross Linked Polyethylene cup System
Highly Cross Linked Polyethylene cup System
Total hip arthroplasty with Highly Cross Linked Polyethylene cup System
Interventions
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Metal on Metal Hip System
Total hip arthroplasty with a metal on metal component system
Highly Cross Linked Polyethylene cup System
Total hip arthroplasty with Highly Cross Linked Polyethylene cup System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects undergoing cementless hip arthroplasty. If a press fit metal articulation acetabulum is not possible; the modular cup system will be utilized with screw fixation and a metal head of the greatest diameter deemed appropriate and safe for the patient will be utilized.(At the discretion of the surgeon). The cup in this situation may have a metal or poly articulation. The patient will be followed as an intent to treat (the patient will be evaluated and included in the group as randomized)
* Subjects with, but not limited to, original diagnoses of osteoarthritis, avascular necrosis, rheumatoid arthritis, congenital dysplasia of the hip, ankylosing spondylitis, posttraumatic arthritis, and traumatic injury to the hip joint.
* Subjects who are able and willing to understand the conditions of informed consent, to participate in the study according to the protocol for the length of the expected term of follow-up, and to follow their physician's directions.
Exclusion Criteria
* Subjects with gross obesity, \>45% over ideal body weight for age and height. Refer to Appendix A, Obesity Table.
* Subjects with active infections.
* Subjects with malignancy in the area of the involved hip joint.
* Subjects with a neuromuscular deficit that interferes with the subject's ability to limit weight bearing or places an extreme load on the implant during the healing period.
* Subjects with a diagnosis of Fibromyalgia
* Female subjects who are pregnant or may be pregnant.
* Subjects whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol, or are reasonably unlikely to be compliant with the prescribed postoperative routine and the follow-up evaluation schedule.
* Subjects who have a known sensitivity to device materials.
65 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Nova Scotia Health Authority
OTHER
Responsible Party
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Principal Investigators
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Ross K Leighton, MD
Role: PRINCIPAL_INVESTIGATOR
Nova Scotia Health Authority
Other Identifiers
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RL 006
Identifier Type: -
Identifier Source: org_study_id
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