Bone Forming at Prosthetic Surfaces. Fingerprint2

April 3, 2014 updated by: Uppsala University

Bone Forming at Prosthetic Surfaces. A Randomized Clinical F-PET/CT Study

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?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gävle, Sweden, 80187
        • Recruiting
        • Centre for research and development Uppsala university/County council of Gävleborg
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Uncemented HA-coated Corail stem with a ceramic 32 mm head
Active Comparator: Regenerex
Device: Component for acetabulum (Regenerex RingLoc cup)
A fibrous metal uncemented Regenerex RingLoc cup (Biomet, Warsaw, Il, USA)
Other Names:
  • 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 Names:
  • 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 Names:
  • Cemented Lubinus SP II stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks after surgery
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.
6 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
FEMUR:to analyze difference in SUV for each individual ROI inbetween the cemented and uncemented femur group
Time Frame: 6 weeks and 6 months
6 weeks and 6 months
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
6 weks and 6 months
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
preoperatively, 6 weeks and 6 months
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
6 months
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 months
ACETABULUM: to analyze difference in SUV for each individual ROI between the 2 study groups
Time Frame: 6 weeks and 6 months
6 weeks and 6 months
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
6 weeks and 6 months
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
preoperatively, 6 weeks and 6 months
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
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Study Chair: Gösta Ullmark, Ass Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

January 17, 2012

First Submitted That Met QC Criteria

June 19, 2012

First Posted (Estimate)

June 20, 2012

Study Record Updates

Last Update Posted (Estimate)

April 4, 2014

Last Update Submitted That Met QC Criteria

April 3, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUllmark Apr -12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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