Hemi Knee Arthroplasty, Patello-femoral Osteoarthritis
Conditions
Keywords
Patello femoral, osteoarthritis, arthroplasty
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.
Interventions
DEVICEiDXA 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
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Lunar orthopedic knee software. | 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. |
Countries
New Zealand
Outcome results
None listed