Evaluation of Orthopedic Knee Measurement Using Lunar iDXA
This study has been completed.
Information provided by (Responsible Party):
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.
Hemi Knee Arthroplasty
Device: iDXA knee software
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||Evaluation of Orthopedic Knee Measurement Using Lunar iDXA
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2011 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||30 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348958
|CGM Research Trust - Princess Margaret Hospital
|Cashmere, Christchurch, New Zealand, 8022 |
||Nigel Gilchrist, M.D.
||CGM Reseach Trust - Princess Margaret Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 2, 2011
||July 14, 2014
||New Zealand: Medsafe
Keywords provided by GE Healthcare:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 02, 2016