Hemi Knee ArthroplastyNCT01348958
Evaluation of Orthopedic Knee Measurement Using Lunar iDXA
A study testing iDXA knee software in people with Hemi Knee Arthroplasty and Patello-femoral Osteoarthritis, run by GE Healthcare at 1 site in New Zealand.
Trial summary
This study is to compare scans of the knee performed using new software designed specifically to look at the knee joint with those performed using approved software designed for scans of the hip. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Hemi Knee Arthroplasty, Patello-femoral Osteoarthritis
- What is being tested?
- iDXA knee software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNew Zealand
- Study dates
- Jul 2011to Sep 2011
- Phase
- Interventional
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>30 years) males and females.
- Have had a hemi knee replacement of one knee at least 8 weeks ago.
- Patello-femoral osteoarthritis is not a contraindication if person does not have symptoms from the patello-femoral joint.
- Able to provide informed consent.
- In good general health.
Who cannot join
- Neuromuscular or vascular disease in the affected leg.
- Found to be unsuitable for hemi knee arthroplasty (KA) before or at surgery.
- Preoperative extensions defect greater than 15 degrees.
- Preoperative maximal flexion of less than 100 degrees.
- Symptomatic patello-femoral osteoarthritis.
- Insufficiency of anterior cruciate ligament (ACL)
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- Fracture sequalae (Intraarticular fracture and all tibial condyle fractures).
- Previous osteotomy.
- Previous extensive knee surgery.
- Metabolic bone disease including osteoporosis with a T score of <-2.5.
- Rheumatoid arthritis.
- Postmenopausal women on systemic hormone replacement therapy (HRT).
- Long-term treatment with oral corticosteroids and/or bisphosphonates.
- Inability to consent (such as Alzheimer's Disease).
- Misuse of drugs or alcohol.
- Serious psychiatric disease.
- Disseminated malignant disease and treatment with radiotherapy or chemotherapy.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
CGM Research Trust - Princess Margaret Hospital
Cashmere, Christchurch, 8022
About this study
This study is to compare scans of the knee performed using new software designed specifically to look at the knee joint with those performed using approved software designed for scans of the hip.
- Being tested
- iDXA knee software
- Keywords
- Patello femoral, osteoarthritis, arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iDXA knee softwareDevice
Also called DXA, iDxa
Following surgery, subjects who have undergone knee arthroplasty will have the knee that has undergone arthroplasty (post-operative) scanned at least 8 weeks after surgery.
During one visit, each subject will have the post-operative knee scanned 1 time using Lunar orthopedic application, and 3 times with the subject repositioned between scans using the Lunar orthopedic knee application (total of 4 scans). Lunar iDXA measurement procedures will be done
| Study group | Role | What they receive |
|---|---|---|
| Post-operative knee replacement | Experimental | Subjects that have had a hemi knee replacement of one knee at least 8 weeks ago had the post-operative knee scanned using the orthopedic hip application and the Lunar orthopedic knee application. Receives: Device: iDXA knee software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Lunar orthopedic knee software.
This study will compare the bone density and bone mass measurements acquired with Lunar orthopedic knee software and for the same scans acquired with Lunar orthopedic software. A determination of precision of bone measurements acquired and analyzed with Lunar orthopedic knee software.
Measured: 5 months from starting study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemi Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nigel Gilchrist, M.D., Principal investigator, CGM Reseach Trust - Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348958
- Sponsor's protocol ID
- 105-2011-GES-0001-000
- Status last verified
- Jun 2017
- First submitted
- 2 May 2011
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Orthopedic Knee Measurement Using Lunar iDXA
- ClinicalTrials.gov ID
- NCT01348958
- Acronym / sponsor ID
- 105-2011-GES-0001-000
- Keywords
- Patello femoral, osteoarthritis, arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 6 May 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.
This study is to compare scans of the knee performed using new software designed specifically to look at the knee joint with those performed using approved software designed for scans of the hip.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-operative knee replacement | Experimental | Device: iDXA knee softwareSubjects that have had a hemi knee replacement of one knee at least 8 weeks ago had the post-operative knee scanned using the orthopedic hip application and the Lunar orthopedic knee application. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (>30 years) males and females.
- Have had a hemi knee replacement of one knee at least 8 weeks ago.
- Patello-femoral osteoarthritis is not a contraindication if person does not have symptoms from the patello-femoral joint.
- Able to provide informed consent.
- In good general health.
Key exclusion criteria (17 listed)
- Neuromuscular or vascular disease in the affected leg.
- Found to be unsuitable for hemi knee arthroplasty (KA) before or at surgery.
- Preoperative extensions defect greater than 15 degrees.
- Preoperative maximal flexion of less than 100 degrees.
- Symptomatic patello-femoral osteoarthritis.
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 |
|---|---|---|
| iDXA knee softwareAlso: DXA, iDxaFollowing surgery, subjects who have undergone knee arthroplasty will have the knee that has undergone arthroplasty (post-operative) scanned at least 8 weeks after surgery. During one visit, each subject will have the post-operative knee scanned 1 time using Lunar orthopedic application, and 3 times with the subject repositioned between scans using the Lunar orthopedic knee application (total of 4 scans). Lunar iDXA measurement procedures will be done | Device | Post-operative knee replacement |
Primary outcome
Efficacy of Lunar orthopedic knee software.
Time frame: 5 months from starting study.
This study will compare the bone density and bone mass measurements acquired with Lunar orthopedic knee software and for the same scans acquired with Lunar orthopedic software. A determination of precision of bone measurements acquired and analyzed with Lunar orthopedic knee software.
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 22 Jun 2017.
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.
Nigel Gilchrist, M.D. principal investigator
CGM Reseach Trust - Princess Margaret Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iDXA knee software in people with Hemi Knee Arthroplasty and Patello-femoral Osteoarthritis, run by GE Healthcare at 1 site in New Zealand.
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 5 inclusion and 17 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 22 Jun 2017. 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 New Zealand. 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.
What does the primary outcome measure?
Efficacy of Lunar orthopedic knee software. (time frame: 5 months from starting study.). It is what the study was designed to measure, not a finding.
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 22 Jun 2017.