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Evaluation of Orthopedic Knee Measurement Using Lunar iDXA

This study has been completed.
Information provided by (Responsible Party):
GE Healthcare Identifier:
First received: May 2, 2011
Last updated: July 14, 2014
Last verified: July 2014
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 Phase
Hemi Knee Arthroplasty
Patello-femoral Osteoarthritis
Device: iDXA knee software
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Orthopedic Knee Measurement Using Lunar iDXA

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)
Intervention Details:
    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

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

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
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Please refer to this study by its identifier: NCT01348958

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

Responsible Party: GE Healthcare Identifier: NCT01348958     History of Changes
Other Study ID Numbers: 105-2011-GES-0001-000
Study First Received: May 2, 2011
Last Updated: July 14, 2014

Keywords provided by GE Healthcare:
Patello femoral

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on April 27, 2017