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Evaluation of Orthopedic Knee Measurement Using Lunar iDXA

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01348958
First Posted: May 6, 2011
Last Update Posted: June 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GE Healthcare
  Purpose
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.

Condition Intervention
Hemi Knee Arthroplasty Patello-femoral Osteoarthritis Device: iDXA knee software

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Orthopedic Knee Measurement Using Lunar iDXA

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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.


Enrollment: 36
Study Start Date: July 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: 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

Other Names:
  • DXA
  • iDxa

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01348958


Locations
New Zealand
CGM Research Trust - Princess Margaret Hospital
Cashmere, Christchurch, New Zealand, 8022
Sponsors and Collaborators
GE Healthcare
Investigators
Principal Investigator: Nigel Gilchrist, M.D. CGM Reseach Trust - Princess Margaret Hospital
  More Information

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01348958     History of Changes
Other Study ID Numbers: 105-2011-GES-0001-000
First Submitted: May 2, 2011
First Posted: May 6, 2011
Last Update Posted: June 22, 2017
Last Verified: June 2017

Keywords provided by GE Healthcare:
Patello femoral
osteoarthritis
arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases