Evaluation of Orthopedic Knee Measurement Using Lunar iDXA

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.

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Key information

Conditions

Hemi Knee Arthroplasty Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Patello-femoral Osteoarthritis Rheumatic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CGM Research Trust - Princess Margaret Hospital

Cashmere, Christchurch, 8022, New Zealand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iDXA knee software

Device

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

Other names: DXA, iDxa

Primary outcomes

Efficacy of Lunar orthopedic knee software.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: May 6, 2011
Registry last updated: Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed