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
26 participants
INTERVENTIONAL
2011-08-31
2015-03-31
Brief Summary
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Detailed Description
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Intervention will be surgery with a total hip arthroplasty. The studied endoprosthetic components are: Cemented Lubinus SP II stem with a ceramic 32 mm head, a cemented Lubinus cross linked cup (Waldemar Link, Hamburg, Germany). Palacose cement with gentamycin, applied with 3:rd generation cementation technique will be used for those cemented implants.
Uncemented HA-coated Corail stem with a ceramic 32 mm head (DePuy, Johnson \& Johnson, USA), a fibrous metal Regenerex RingLoc cup (Biomet, Warsaw, Il, USA) All cups will have cross linked Ultra-high-molecular-weight polyethylene (UHWMP).
Clinical score, radiography and PET uptake of Fluoride tracer (SUV) adjacent to the prosthetic surfaces will be analyzed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Regenerex
Component for acetabulum (Regenerex RingLoc cup)
A fibrous metal uncemented Regenerex RingLoc cup (Biomet, Warsaw, Il, USA)
Lub cup
Components for the acetabulum (Lubinus cross linked cup)
cemented Lubinus cross linked cup (Waldemar Link, Hamburg, Germany).
SP II
Arthroplasty components are for the femur (Cemented Lubinus SP II stem)
Cemented Lubinus SP II stem (Waldemar Link, Hamburg, Germany) with a ceramic 32 mm head.
Corail
Arthroplasty components are for the femur (Corail stem)
Uncemented HA-coated Corail stem with a ceramic 32 mm head (DePuy, Johnsson \& Johnsson, USA).
Interventions
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Component for acetabulum (Regenerex RingLoc cup)
A fibrous metal uncemented Regenerex RingLoc cup (Biomet, Warsaw, Il, USA)
Components for the acetabulum (Lubinus cross linked cup)
cemented Lubinus cross linked cup (Waldemar Link, Hamburg, Germany).
Arthroplasty components are for the femur (Cemented Lubinus SP II stem)
Cemented Lubinus SP II stem (Waldemar Link, Hamburg, Germany) with a ceramic 32 mm head.
Arthroplasty components are for the femur (Corail stem)
Uncemented HA-coated Corail stem with a ceramic 32 mm head (DePuy, Johnsson \& Johnsson, USA).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
50 Years
69 Years
ALL
No
Sponsors
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Uppsala University
OTHER
Responsible Party
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Principal Investigators
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Gösta Ullmark
Role: STUDY_CHAIR
Ass Professor
Locations
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Centre for research and development Uppsala university/County council of Gävleborg
Gävle, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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Ullmark G, Sorensen J, Nilsson O, Maripuu E. Bone mineralisation adjacent to cemented and uncemented acetabular cups: analysis by [18F]-fluoride-PET in a randomised clinical trial. Hip Int. 2020 Nov;30(6):745-751. doi: 10.1177/1120700019861274. Epub 2020 Jul 19.
Ullmark G, Sorensen J, Maripuu E, Nilsson O. Fingerprint pattern of bone mineralisation on cemented and uncemented femoral stems: analysis by [18F]-fluoride-PET in a randomised clinical trial. Hip Int. 2019 Nov;29(6):609-617. doi: 10.1177/1120700018815404. Epub 2018 Dec 6.
Other Identifiers
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GUllmark Apr -12
Identifier Type: -
Identifier Source: org_study_id
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