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Bone Forming at Prosthetic Surfaces. Fingerprint2

Primary Purpose

Osteo Arthritis

Status
Unknown status
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Component for acetabulum (Regenerex RingLoc cup)
Components for the acetabulum (Lubinus cross linked cup)
Arthroplasty components are for the femur (Cemented Lubinus SP II stem)
Arthroplasty components are for the femur (Corail stem)
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis focused on measuring total hip arthroplasty, bone metabolism, mineralisation

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for research and development Uppsala university/County council of GävleborgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Regenerex

Lub cup

SP II

Corail

Arm Description

Outcomes

Primary Outcome Measures

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
There are two study groups for femur: cemented and uncemented femur prosthetic components. There are also a femur reference group.
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
There are two study groups for acetabulum: cemented and uncemented acetabular prosthetic components. There are also an acetabular reference group.

Secondary Outcome Measures

FEMUR:to analyze difference in SUV for each individual ROI inbetween the cemented and uncemented femur group
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.
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.
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
FEMUR:to analyze difference in SUV for the 4 upper ROI's analyzed together between each study group and the reference group
ACETABULUM: to analyze difference in SUV for each individual ROI between the 2 study groups
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.
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.
ACETABULUM: to analyze difference in SUV of all 9 ROI's analyzed together between the cemented and uncemented acetabular study groups
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

Full Information

First Posted
January 17, 2012
Last Updated
April 3, 2014
Sponsor
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT01623687
Brief Title
Bone Forming at Prosthetic Surfaces. Fingerprint2
Official Title
Bone Forming at Prosthetic Surfaces. A Randomized Clinical F-PET/CT Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis
Keywords
total hip arthroplasty, bone metabolism, mineralisation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regenerex
Arm Type
Active Comparator
Arm Title
Lub cup
Arm Type
Active Comparator
Arm Title
SP II
Arm Type
Active Comparator
Arm Title
Corail
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Component for acetabulum (Regenerex RingLoc cup)
Other Intervention Name(s)
Regenerex RingLoc cup
Intervention Description
A fibrous metal uncemented Regenerex RingLoc cup (Biomet, Warsaw, Il, USA)
Intervention Type
Device
Intervention Name(s)
Components for the acetabulum (Lubinus cross linked cup)
Other Intervention Name(s)
Lubinus cross linked cup
Intervention Description
cemented Lubinus cross linked cup (Waldemar Link, Hamburg, Germany).
Intervention Type
Device
Intervention Name(s)
Arthroplasty components are for the femur (Cemented Lubinus SP II stem)
Other Intervention Name(s)
Cemented Lubinus SP II stem
Intervention Description
Cemented Lubinus SP II stem (Waldemar Link, Hamburg, Germany) with a ceramic 32 mm head.
Intervention Type
Device
Intervention Name(s)
Arthroplasty components are for the femur (Corail stem)
Other Intervention Name(s)
Uncemented HA-coated Corail stem with a ceramic 32 mm head
Intervention Description
Uncemented HA-coated Corail stem with a ceramic 32 mm head (DePuy, Johnsson & Johnsson, USA).
Primary Outcome Measure Information:
Title
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
Description
There are two study groups for femur: cemented and uncemented femur prosthetic components. There are also a femur reference group.
Time Frame
6 weeks after surgery
Title
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
Description
There are two study groups for acetabulum: cemented and uncemented acetabular prosthetic components. There are also an acetabular reference group.
Time Frame
6 weeks after surgery
Secondary Outcome Measure Information:
Title
FEMUR:to analyze difference in SUV for each individual ROI inbetween the cemented and uncemented femur group
Time Frame
6 weeks and 6 months
Title
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
Title
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
Title
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
Title
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
Title
ACETABULUM: to analyze difference in SUV for each individual ROI between the 2 study groups
Time Frame
6 weeks and 6 months
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gösta Ullmark, MD, PhD
Phone
+46706466149
Email
gosta.ullmark@lg.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gösta Ullmark
Organizational Affiliation
Ass Professor
Official's Role
Study Chair
Facility Information:
Facility Name
Centre for research and development Uppsala university/County council of Gävleborg
City
Gävle
ZIP/Postal Code
80187
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gösta Ullmark, MD, PhD
Phone
+46706466149
Email
gosta.ullmark@lg.se

12. IPD Sharing Statement

Citations:
PubMed Identifier
32686502
Citation
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.
Results Reference
derived
PubMed Identifier
30520317
Citation
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.
Results Reference
derived

Learn more about this trial

Bone Forming at Prosthetic Surfaces. Fingerprint2

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