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Evaluation of Orthopedic Knee Measurement Using Lunar iDXA

Primary Purpose

Hemi Knee Arthroplasty, Patello-femoral Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
iDXA knee software
Sponsored by
GE Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hemi Knee Arthroplasty focused on measuring Patello femoral, osteoarthritis, arthroplasty

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CGM Research Trust - Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Post-operative knee replacement

Arm Description

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.

Outcomes

Primary Outcome Measures

Efficacy of Lunar orthopedic knee software.
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.

Secondary Outcome Measures

Full Information

First Posted
May 2, 2011
Last Updated
June 20, 2017
Sponsor
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT01348958
Brief Title
Evaluation of Orthopedic Knee Measurement Using Lunar iDXA
Official Title
Evaluation of Orthopedic Knee Measurement Using Lunar iDXA
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemi Knee Arthroplasty, Patello-femoral Osteoarthritis
Keywords
Patello femoral, osteoarthritis, arthroplasty

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post-operative knee replacement
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
iDXA knee software
Other Intervention Name(s)
DXA, iDxa
Intervention Description
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
Primary Outcome Measure Information:
Title
Efficacy of Lunar orthopedic knee software.
Description
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.
Time Frame
5 months from starting study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (>30 years) males and females. Have had a hemi knee replacement of one knee at least 8 weeks ago. Patello-femoral osteoarthritis is not a contraindication if person does not have symptoms from the patello-femoral joint. Able to provide informed consent. In good general health. Exclusion Criteria: Neuromuscular or vascular disease in the affected leg. Found to be unsuitable for hemi knee arthroplasty (KA) before or at surgery. Preoperative extensions defect greater than 15 degrees. Preoperative maximal flexion of less than 100 degrees. Symptomatic patello-femoral osteoarthritis. Insufficiency of anterior cruciate ligament (ACL) Fracture sequalae (Intraarticular fracture and all tibial condyle fractures). Previous osteotomy. Previous extensive knee surgery. Metabolic bone disease including osteoporosis with a T score of <-2.5. Rheumatoid arthritis. Postmenopausal women on systemic hormone replacement therapy (HRT). Long-term treatment with oral corticosteroids and/or bisphosphonates. Inability to consent (such as Alzheimer's Disease). Misuse of drugs or alcohol. Serious psychiatric disease. Disseminated malignant disease and treatment with radiotherapy or chemotherapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigel Gilchrist, M.D.
Organizational Affiliation
CGM Reseach Trust - Princess Margaret Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CGM Research Trust - Princess Margaret Hospital
City
Cashmere
State/Province
Christchurch
ZIP/Postal Code
8022
Country
New Zealand

12. IPD Sharing Statement

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Evaluation of Orthopedic Knee Measurement Using Lunar iDXA

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