RSA Study Using Two Types of Uncemented Acetabular Components and the Uncemented HA Coated Symax Stem
NCT ID: NCT01618084
Last Updated: 2012-06-13
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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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2011-11-30
2014-12-31
Brief Summary
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Study Objectives:
* The primary objective is to determine the prosthetic migration of the uncemented acetabular and femoral total hip components using model based RSA technique
* Secondary objectives are on one hand to assess clinical outcome on the other hand assessing patient satisfaction in both groups using Harris Hip Score, Oxford Hip Score, WOMAC, and EQ-5D questionnaires
* Tertiary objective is to assess bone remodeling of the uncemented acetabular components and the HA-coated Symax hip stem using QCT derived from usinf F18-fluoride PET in a cohort of 12 consecutive patients of this RCT
A total of 50 patients will be enrolled in this RCT divided into two equal groups. Patients have to fulfill the inclusion and exclusion criteria.
All evaluations will be done pre-operatively with 2 weeks before surgery, and after surgery at 4 weeks, 3 and 6 months and 1 and 2 years.
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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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Tritanium cup
Tritanium acetabular component
Total hip arthroplasty using a tritanium uncemented acetabular component
Trident HA cup
Tritanium acetabular component
Total hip arthroplasty using a tritanium uncemented acetabular component
Interventions
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Tritanium acetabular component
Total hip arthroplasty using a tritanium uncemented acetabular component
Eligibility Criteria
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Inclusion Criteria
* Patients requiring uncemented primary THA
* Primary diagnosis of osteoarthritis
Exclusion Criteria
* Patients who had a THA on the contralateral side within last 6 months
* Female patients who are pregnant or planning pregnancy during the course of the study
* Patients with active or suspected infection
* patients with malignancy
* patients with a systemic disease that would effect the subject's welfare or overall outcome of the study
* Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
* Patients with systemic or metabolic disorders leading to progressive bone deterioration
* Patients with other illnesses which are likely to affect their outcome
* Patients with known sensitivity to device materials
35 Years
70 Years
ALL
No
Sponsors
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Stryker Orthopaedics
INDUSTRY
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Lodewijk Van Rhijn, professor
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical centre
Locations
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Maastricht UMC
Maastricht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL 33832.068.10
Identifier Type: OTHER
Identifier Source: secondary_id
MEC10-1-068
Identifier Type: -
Identifier Source: org_study_id
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