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Bone Forming at Prosthetic Surfaces. Fingerprint2

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ClinicalTrials.gov Identifier: NCT01623687
Recruitment Status : Unknown
Verified April 2014 by Uppsala University.
Recruitment status was:  Recruiting
First Posted : June 20, 2012
Last Update Posted : April 4, 2014
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Brief Summary:
What is the intensity of F-PET uptake in healthy and osteo arthritic femur and acetabulum, compared to the uptake adjacent to four analyzed endoprosthetic components 1½ and 6 months after surgery?

Condition or disease Intervention/treatment Phase
Osteo Arthritis Device: Component for acetabulum (Regenerex RingLoc cup) Device: Components for the acetabulum (Lubinus cross linked cup) Device: Arthroplasty components are for the femur (Cemented Lubinus SP II stem) Device: Arthroplasty components are for the femur (Corail stem) Phase 4

Detailed Description:

A clinical study of 26 patients, age 50-69 years, healthy unless osteoarthritis in one hip, randomized in four groups plus a reference group of same 26 patient´s contralateral healthy hip.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bone Forming at Prosthetic Surfaces. A Randomized Clinical F-PET/CT Study
Study Start Date : August 2011
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Regenerex Device: Component for acetabulum (Regenerex RingLoc cup)
A fibrous metal uncemented Regenerex RingLoc cup (Biomet, Warsaw, Il, USA)
Other Name: Regenerex RingLoc cup

Active Comparator: Lub cup Device: Components for the acetabulum (Lubinus cross linked cup)
cemented Lubinus cross linked cup (Waldemar Link, Hamburg, Germany).
Other Name: Lubinus cross linked cup

Active Comparator: SP II Device: 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.
Other Name: Cemented Lubinus SP II stem

Active Comparator: Corail Device: Arthroplasty components are for the femur (Corail stem)
Uncemented HA-coated Corail stem with a ceramic 32 mm head (DePuy, Johnsson & Johnsson, USA).
Other Name: Uncemented HA-coated Corail stem with a ceramic 32 mm head




Primary Outcome Measures :
  1. FEMUR: to analyze difference in SUV of the 4 upper ROI`s (No 1, 7, 8 and 13) analyzed together between the cemented and uncemented groups AND: to analyze SUV of the 4 upper ROI's analyzed together between each femur study group and the reference group [ Time Frame: 6 weeks after surgery ]
    There are two study groups for femur: cemented and uncemented femur prosthetic components. There are also a femur reference group.

  2. ACETABULUM: to analyze difference in SUV of all 9 ROI`s analyzed together between the cemented and uncemented acetabular study groups, and to analyze SUV of all 9 ROI`s analyzed together between each acetabulum study group and the reference group [ Time Frame: 6 weeks after surgery ]
    There are two study groups for acetabulum: cemented and uncemented acetabular prosthetic components. There are also an acetabular reference group.


Secondary Outcome Measures :
  1. FEMUR:to analyze difference in SUV for each individual ROI inbetween the cemented and uncemented femur group [ Time Frame: 6 weeks and 6 months ]
  2. FEMUR: to analyze difference in SUV for each individual ROI between the cemented study group and the reference group. To analyze difference in SUV for each individual ROI between the uncemented study group and the reference group. [ Time Frame: 6 weks and 6 months ]
  3. FEMUR:to analyze difference in SUV for each individual ROI between the 3 time points for the cemented group. To analyze difference in SUV for each individual ROI between the 3 time points for the uncemented group. [ Time Frame: preoperatively, 6 weeks and 6 months ]
  4. FEMUR:to analyze difference in SUV for the 4 upper ROI`s (No 1, 7, 8 and 13)analyzed together between the 2 study groups [ Time Frame: 6 months ]
  5. FEMUR:to analyze difference in SUV for the 4 upper ROI's analyzed together between each study group and the reference group [ Time Frame: 6 months ]
  6. ACETABULUM: to analyze difference in SUV for each individual ROI between the 2 study groups [ Time Frame: 6 weeks and 6 months ]
  7. ACETABULUM: to analyze difference in SUV for each individual ROI between the cemented study group and the reference group. To analyze difference in SUV for each individual ROI between the uncemented study group and the reference group. [ Time Frame: 6 weeks and 6 months ]
  8. ACETABULUM: to analyze difference in SUV for each individual ROI for the cemented study group between the 3 time points. To analyze difference in SUV for each individual ROI for the uncemented study group between the 3 time points. [ Time Frame: preoperatively, 6 weeks and 6 months ]
  9. ACETABULUM: to analyze difference in SUV of all 9 ROI`s analyzed together between the cemented and uncemented acetabular study groups [ Time Frame: 6 months ]
  10. ACETABULUM: to analyze difference in SUV of all 9 ROI`s analyzed together between the cemented and uncemented acetabular study groups, and to analyze SUV of all 9 ROI`s analyzed together between each acetabulum study group and the reference group [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients diagnosed to have unilateral hip osteo arthritis (Charnley group A) aimed for THA at the orthopedic clinic Gävle hospital.

Exclusion Criteria:

  • Systemic disease or medication affecting the skeleton

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623687


Contacts
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Contact: Gösta Ullmark, MD, PhD +46706466149 gosta.ullmark@lg.se

Locations
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Sweden
Centre for research and development Uppsala university/County council of Gävleborg Recruiting
Gävle, Sweden, 80187
Contact: Gösta Ullmark, MD, PhD    +46706466149    gosta.ullmark@lg.se   
Sponsors and Collaborators
Uppsala University
Investigators
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Study Chair: Gösta Ullmark Ass Professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01623687     History of Changes
Other Study ID Numbers: GUllmark Apr -12
First Posted: June 20, 2012    Key Record Dates
Last Update Posted: April 4, 2014
Last Verified: April 2014
Keywords provided by Uppsala University:
total hip arthroplasty
bone metabolism
mineralisation
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases