Evaluation of Orthopedic Knee Measurement Using Lunar iDXA

June 20, 2017 updated by: GE Healthcare
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
    • Christchurch
      • Cashmere, Christchurch, New Zealand, 8022
        • CGM Research Trust - Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 months from starting study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GE Healthcare

Investigators

  • Principal Investigator: Nigel Gilchrist, M.D., CGM Reseach Trust - Princess Margaret Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

May 2, 2011

First Submitted That Met QC Criteria

May 4, 2011

First Posted (ESTIMATE)

May 6, 2011

Study Record Updates

Last Update Posted (ACTUAL)

June 22, 2017

Last Update Submitted That Met QC Criteria

June 20, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105-2011-GES-0001-000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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