OsteoarthrosisX-PanderNCT01443975
Clinical Evaluation on the Use of the X-pander Device
An observational study of Osteoarthrosis and Total Hip Arthroplasty, run by Northern Orthopaedic Division, Denmark at 2 sites in Denmark.
Trial summary
The purpose of this study is to clinically evaluate the use of the x-pander device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthrosis, Total Hip Arthroplasty
- What is being tested?
- x-pander
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2011to Jun 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients for primary THA
Who may be able to join
- Clinical diagnosis for hip osteoarthrosis
Who cannot join
- Previous surgery of the actual hip
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Ortopaedic Clinic
Farsoe Hospital, Aalborg University Hospital, 9640
Ortopaedic Clinic
Frederikshavn Hospital, Aalborg University Hospital, 9900
About this study
The purpose of this study is to clinically evaluate the use of the x-pander device.
Read the detailed description
Clinical evaluation on the use of the x-pander device during THA-surgery
- Conditions
- Osteoarthrosis, Total Hip Arthroplasty
- Being tested
- x-pander
- Keywords
- Total Hip Arthroplasty, Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
x-panderProcedure or surgery
Measurement of the size and quality of the bony acetabulum before mounting the artificial hip socket.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Measurement with x-pander in acetabulum prior to inserting the artificial hip socket. Receives: Procedure: x-pander |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthrosisStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Company Medichanical Engineering
- Responsible party
- Sponsor
- Investigators
- Mogens B. Laursen, MD, PhD, Principal investigator, Orthopaedic Surgery Research Unit, Aalborg Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443975
- Sponsor's protocol ID
- N-20110043
- Acronym
- X-Pander
- Status last verified
- Mar 2014
- First submitted
- 29 Sep 2011
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation on the Use of the X-pander Device
- ClinicalTrials.gov ID
- NCT01443975
- Acronym / sponsor ID
- X-Pander / N-20110043
- Conditions
- Osteoarthrosis, Total Hip Arthroplasty
- Keywords
- Total Hip Arthroplasty, Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- Company Medichanical Engineering
- Study start
- Sep 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Sep 2011 (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.
The purpose of this study is to clinically evaluate the use of the x-pander device.
Detailed description
Clinical evaluation on the use of the x-pander device during THA-surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Procedure: x-panderMeasurement with x-pander in acetabulum prior to inserting the artificial hip socket. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients for primary THA
Key inclusion criteria (1 listed)
- Clinical diagnosis for hip osteoarthrosis
Key exclusion criteria (1 listed)
- Previous surgery of the actual hip
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 |
|---|---|---|
| x-panderMeasurement of the size and quality of the bony acetabulum before mounting the artificial hip socket. | Procedure or surgery | All patients |
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 31 Mar 2014.
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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.
Mogens B. Laursen, MD, PhD principal investigator
Orthopaedic Surgery Research Unit, Aalborg Hospital, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthrosis and Total Hip Arthroplasty, run by Northern Orthopaedic Division, Denmark at 2 sites in Denmark.
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: finished, as of the sponsor's last update on 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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.
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 31 Mar 2014.