Osteo ArthritisPhase 4NCT01623687
Bone Forming at Prosthetic Surfaces. Fingerprint2
A Phase 4 study testing Component for acetabulum (Regenerex RingLoc cup), Components for the acetabulum (Lubinus cross linked cup) and Arthroplasty components are for the femur (Cemented Lubinus SP II stem) in people with Osteo Arthritis, run by Uppsala University at 1 site in Sweden.
Trial 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? Read more about this study
- Who is it for?
- Ages 50 to 69 years
- Conditions the study is for
- Osteo Arthritis
- What is being tested?
- Component for acetabulum (Regenerex RingLoc cup), Components for the acetabulum (Lubinus cross linked cup) and Arthroplasty components are for the femur (Cemented Lubinus SP II stem)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2011to Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed to have unilateral hip osteo arthritis (Charnley group A) aimed for THA at the orthopedic clinic Gävle hospital.
Who cannot join
- Systemic disease or medication affecting the skeleton
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Centre for research and development Uppsala university/County council of Gävleborg
Gävle, 80187
Gösta Ullmark, MD, PhD, +46706466149, gosta.ullmark@lg.se
About this study
Official title: 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?
Read the 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.
- Conditions
- Osteo Arthritis
- Being tested
- 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)
- Keywords
- total hip arthroplasty, bone metabolism, mineralisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Component for acetabulum (Regenerex RingLoc cup)Device
Also called Regenerex RingLoc cup
A fibrous metal uncemented Regenerex RingLoc cup (Biomet, Warsaw, Il, USA)
Components for the acetabulum (Lubinus cross linked cup)Device
Also called Lubinus cross linked cup
cemented Lubinus cross linked cup (Waldemar Link, Hamburg, Germany).
Arthroplasty components are for the femur (Cemented Lubinus SP II stem)Device
Also called 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)Device
Also called Uncemented HA-coated Corail stem with a ceramic 32 mm head
Uncemented HA-coated Corail stem with a ceramic 32 mm head (DePuy, Johnsson \& Johnsson, USA).
| Study group | Role | What they receive |
|---|---|---|
| Regenerex | Active comparator | Not described Receives: Device: Component for acetabulum (Regenerex RingLoc cup) |
| Lub cup | Active comparator | Not described Receives: Device: Components for the acetabulum (Lubinus cross linked cup) |
| SP II | Active comparator | Not described Receives: Device: Arthroplasty components are for the femur (Cemented Lubinus SP II stem) |
| Corail | Active comparator | Not described Receives: Device: Arthroplasty components are for the femur (Corail stem) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
There are two study groups for acetabulum: cemented and uncemented acetabular prosthetic components. There are also an acetabular reference group.
Measured: 6 weeks after surgery
Secondary outcomes (10)
FEMUR:to analyze difference in SUV for each individual ROI inbetween the cemented and uncemented femur group
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 months
FEMUR:to analyze difference in SUV for the 4 upper ROI's analyzed together between each study group and the reference group
Measured: 6 months
ACETABULUM: to analyze difference in SUV for each individual ROI between the 2 study groups
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startAug 2011
- Primary completionSep 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteo ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gösta Ullmark, Study chair, Ass Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623687
- Sponsor's protocol ID
- GUllmark Apr -12
- Status last verified
- Apr 2014
- First submitted
- 17 Jan 2012
- Last updated
- 4 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32686502Ullmark 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.
PubMed 30520317
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Forming at Prosthetic Surfaces. A Randomized Clinical F-PET/CT Study
- ClinicalTrials.gov ID
- NCT01623687
- Acronym / sponsor ID
- GUllmark Apr -12
- Conditions
- Osteo Arthritis
- Keywords
- total hip arthroplasty, bone metabolism, mineralisation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 20 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regenerex | Active comparator | Device: Component for acetabulum (Regenerex RingLoc cup) |
| Lub cup | Active comparator | Device: Components for the acetabulum (Lubinus cross linked cup) |
| SP II | Active comparator | Device: Arthroplasty components are for the femur (Cemented Lubinus SP II stem) |
| Corail | Active comparator | Device: Arthroplasty components are for the femur (Corail stem) |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed to have unilateral hip osteo arthritis (Charnley group A) aimed for THA at the orthopedic clinic Gävle hospital.
Key exclusion criteria (1 listed)
- Systemic disease or medication affecting the skeleton
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Component for acetabulum (Regenerex RingLoc cup)Also: Regenerex RingLoc cupA fibrous metal uncemented Regenerex RingLoc cup (Biomet, Warsaw, Il, USA) | Device | Regenerex |
| Components for the acetabulum (Lubinus cross linked cup)Also: Lubinus cross linked cupcemented Lubinus cross linked cup (Waldemar Link, Hamburg, Germany). | Device | Lub cup |
| Arthroplasty components are for the femur (Cemented Lubinus SP II stem)Also: Cemented Lubinus SP II stemCemented Lubinus SP II stem (Waldemar Link, Hamburg, Germany) with a ceramic 32 mm head. | Device | SP II |
| Arthroplasty components are for the femur (Corail stem)Also: Uncemented HA-coated Corail stem with a ceramic 32 mm headUncemented HA-coated Corail stem with a ceramic 32 mm head (DePuy, Johnsson \& Johnsson, USA). | Device | Corail |
Primary outcome
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.
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.
10 secondary outcomes
FEMUR:to analyze difference in SUV for each individual ROI inbetween the cemented and uncemented femur group
Time frame: 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
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
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
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
ACETABULUM: to analyze difference in SUV for each individual ROI between the 2 study groups
Time frame: 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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2014.
- Derived from this study: PubMed 32686502Ullmark 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.
- Derived from this study: PubMed 30520317Ullmark 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gösta Ullmark study chair
Ass Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Component for acetabulum (Regenerex RingLoc cup), Components for the acetabulum (Lubinus cross linked cup) and Arthroplasty components are for the femur (Cemented Lubinus SP II stem) in people with Osteo Arthritis, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gösta Ullmark, MD, PhD (+46706466149, gosta.ullmark@lg.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01623687, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2014.