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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01348958




Registration number
NCT01348958
Ethics application status
Date submitted
2/05/2011
Date registered
6/05/2011
Date last updated
22/06/2017

Titles & IDs
Public title
Evaluation of Orthopedic Knee Measurement Using Lunar iDXA
Scientific title
Evaluation of Orthopedic Knee Measurement Using Lunar iDXA
Secondary ID [1] 0 0
105-2011-GES-0001-000
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemi Knee Arthroplasty 0 0
Patello-femoral Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - iDXA knee software

Experimental: Post-operative knee replacement - 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.


Treatment: Devices: iDXA knee software
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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy of Lunar orthopedic knee software.
Timepoint [1] 0 0
5 months from starting study.

Eligibility
Key inclusion criteria
1. Adult (>30 years) males and females.
2. Have had a hemi knee replacement of one knee at least 8 weeks ago.
3. Patello-femoral osteoarthritis is not a contraindication if person does not have symptoms from the patello-femoral joint.
4. Able to provide informed consent.
5. In good general health.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Neuromuscular or vascular disease in the affected leg.
2. Found to be unsuitable for hemi knee arthroplasty (KA) before or at surgery.
3. Preoperative extensions defect greater than 15 degrees.
4. Preoperative maximal flexion of less than 100 degrees.
5. Symptomatic patello-femoral osteoarthritis.
6. Insufficiency of anterior cruciate ligament (ACL)
7. Fracture sequalae (Intraarticular fracture and all tibial condyle fractures).
8. Previous osteotomy.
9. Previous extensive knee surgery.
10. Metabolic bone disease including osteoporosis with a T score of <-2.5.
11. Rheumatoid arthritis.
12. Postmenopausal women on systemic hormone replacement therapy (HRT).
13. Long-term treatment with oral corticosteroids and/or bisphosphonates.
14. Inability to consent (such as Alzheimer's Disease).
15. Misuse of drugs or alcohol.
16. Serious psychiatric disease.
17. Disseminated malignant disease and treatment with radiotherapy or chemotherapy.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2011
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GE Healthcare
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT01348958
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nigel Gilchrist, M.D.
Address 0 0
CGM Reseach Trust - Princess Margaret Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01348958