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Evaluation of Orthopedic Knee Measurement Using Lunar iDXA

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01348958
First received: May 2, 2011
Last updated: November 17, 2011
Last verified: November 2011
History of Changes
  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 Phase
Hemi Knee Arthroplasty
Patello-femoral Osteoarthritis
 Device: iDXA knee software
 Phase 1
Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Efficacy of Lunar orthopedic knee software. [ Time Frame: 5 months from starting study. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: December 2011
Primary Completion Date: August 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
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: David Ergun, Ph.D., GE Healthcare - Lunar
ClinicalTrials.gov Identifier: NCT01348958     History of Changes
Other Study ID Numbers: 105-2011-GES-0001-000
Study First Received: May 2, 2011
Last Updated: November 17, 2011
Health Authority: New Zealand: Medsafe

Keywords provided by GE Healthcare:
Patello femoral
osteoarthritis
arthroplasty

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

ClinicalTrials.gov processed this record on May 19, 2013