CoxarthrosisDXACorailNCT01046019
Measurement of Early Bone Loss Around a Total Hip Arthroplasty
An observational study of Coxarthrosis, run by Ullevaal University Hospital.
Trial summary
Research with DXA has shown the pattern of bone remodelling around an implant. The baseline and reference value for such calculations is the first measurement after the operation. The baseline measurement is performed at different time from study to study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coxarthrosis
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Aug 2009
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with degenerative hip osteoarthritis decided for operation with total hip arthroplasty.
Who may be able to join
- degenerative hip osteoarthritis
Who cannot join
- metastasis to bone
- dementia
About this study
Official title: Measurement of Early Bone Loss Around a Total Hip Arthroplasty. A Prospective Trial With Dual Energy X-ray Absorptiometry.
Research with DXA has shown the pattern of bone remodelling around an implant. The baseline and reference value for such calculations is the first measurement after the operation. The baseline measurement is performed at different time from study to study. If there is a rapid bone loss the first weeks after an operation, this will influence the reference value and then the results. To evaluate DXA as a method we decided to set up a study with 3 DXA measurements within the first 2 weeks. Our hypothesis is that there is a rapid bone loss the first 2 weeks after operation and that timing of the first post operative measurement will influence the later results.
Read the detailed description
Dual x-ray absorptiometry (DXA) has become the most used and proven to be a precise method to investigate changes in bone mass density (BMD). Research with DXA has shown the pattern of bone remodelling around an implant. Results from implant studies are often presented as changes in BMD as a function of time. The baseline and reference value for such calculations is the first measurement after the operation. The most pronounced bone loss after implantation of hip prosthesis usually comes within 3 months. The baseline measurement is performed at different time from study to study. If there is a rapid bone loss the first weeks after an operation, this will influence the reference value and then the results. To evaluate DXA as a method we decided to set up a study with 3 DXA measurements within the first 2 weeks.
We included 23 patients operated with total hip prosthesis (THP). They were measured with DXA at 1, 5 and 14 days, 3 and 12 months after the operation. Results were given in percent (+/-SD) for each Gruen zone. There were no changes in bone density between the first 3 measurements. In all zones, except zone 1, the lowest BMD was measured after 3 months. We concluded that DXA measurements done within 14 days after the operation can be used as reference measurements for later follow ups.
- Conditions
- Coxarthrosis
- Keywords
- DXA, Hip, Arthroplasty
- Medical subject headings
- Osteoarthritis, Hip
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startSep 2007
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoxarthrosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lars Nordsletten, Professor, Study director, Ullevaal University HospitalBerte G Bøe, MD, Principal investigator, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046019
- Sponsor's protocol ID
- 35-07122b 1.2007.896
- Acronym
- DXACorail
- Status last verified
- Jan 2010
- First submitted
- 8 Jan 2010
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Early Bone Loss Around a Total Hip Arthroplasty. A Prospective Trial With Dual Energy X-ray Absorptiometry.
- ClinicalTrials.gov ID
- NCT01046019
- Acronym / sponsor ID
- DXACorail / 35-07122b 1.2007.896
- Conditions
- Coxarthrosis
- Keywords
- DXA, Hip, Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 11 Jan 2010 (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.
Research with DXA has shown the pattern of bone remodelling around an implant. The baseline and reference value for such calculations is the first measurement after the operation. The baseline measurement is performed at different time from study to study. If there is a rapid bone loss the first weeks after an operation, this will influence the reference value and then the results. To evaluate DXA as a method we decided to set up a study with 3 DXA measurements within the first 2 weeks. Our hypothesis is that there is a rapid bone loss the first 2 weeks after operation and that timing of the first post operative measurement will influence the later results.
Detailed description
Dual x-ray absorptiometry (DXA) has become the most used and proven to be a precise method to investigate changes in bone mass density (BMD). Research with DXA has shown the pattern of bone remodelling around an implant. Results from implant studies are often presented as changes in BMD as a function of time. The baseline and reference value for such calculations is the first measurement after the operation. The most pronounced bone loss after implantation of hip prosthesis usually comes within 3 months. The baseline measurement is performed at different time from study to study. If there is a rapid bone loss the first weeks after an operation, this will influence the reference value and then the results. To evaluate DXA as a method we decided to set up a study with 3 DXA measurements within the first 2 weeks.
We included 23 patients operated with total hip prosthesis (THP). They were measured with DXA at 1, 5 and 14 days, 3 and 12 months after the operation. Results were given in percent (+/-SD) for each Gruen zone. There were no changes in bone density between the first 3 measurements. In all zones, except zone 1, the lowest BMD was measured after 3 months. We concluded that DXA measurements done within 14 days after the operation can be used as reference measurements for later follow ups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with degenerative hip osteoarthritis decided for operation with total hip arthroplasty.
Key inclusion criteria (1 listed)
- degenerative hip osteoarthritis
Key exclusion criteria (2 listed)
- metastasis to bone
- dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
Related trials for Coxarthrosis
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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Three Variants of the PENG Block With and Without Perineural Adjuvants in Older Adults
Hip Osteoarthritis
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.
Lars Nordsletten, Professor study director
Ullevaal University Hospital
Berte G Bøe, MD principal investigator
Ullevaal University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Coxarthrosis, run by Ullevaal University Hospital.
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 2 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: finished, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 6 Jul 2011.