Evaluation of Orthopedic Knee Measurement Using Lunar iDXA

Not Applicable

Completed

• Conditions: Hemi Knee Arthroplasty; Patello-femoral Osteoarthritis
• Interventions: Device: iDXA knee software

• Registration Number: NCT01348958
• Lead Sponsor: GE Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-02
• Study First Submitted QC: 2011-05-04
• Study First Posted: 2011-05-06
• Study Start: 2011-07
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post-operative knee replacement	iDXA knee software	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

CGM Research Trust - Princess Margaret Hospital; 🇳🇿 Cashmere, Christchurch, New Zealand