Evaluation of Orthopedic Knee Measurement Using Lunar iDXA

Hemi Knee Arthroplasty Clinical Trial

Official title:

Evaluation of Orthopedic Knee Measurement Using Lunar iDXA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348958
• Other study ID #: 105-2011-GES-0001-000
• Status: Completed
• Phase: N/A
• First received: May 2, 2011
• Last updated: June 20, 2017
• Start date: July 2011
• Est. completion date: September 2011

Study information

• Verified date: June 2017
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemi Knee Arthroplasty
• Osteoarthritis
• Patello-femoral Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
New Zealand	CGM Research Trust - Princess Margaret Hospital	Cashmere	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 months from starting study.