Evaluation of Orthopedic Knee Measurement Using Lunar iDXA

NCT01348958 | Completed

• 1 other identifier: 105-2011-GES-0001-000
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemi Knee Arthroplasty; Patello-femoral Osteoarthritis

Keywords

Patello femoral; osteoarthritis; arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Post-operative knee replacement

EXPERIMENTAL

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.

Device: iDXA knee software

Interventions

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

Also known as: DXA, iDxa

Post-operative knee replacement

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

CGM Research Trust - Princess Margaret Hospital

Cashmere, Christchurch, 8022, New Zealand

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Nigel Gilchrist, M.D.

  CGM Reseach Trust - Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2011
• First Posted: May 6, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 22, 2017

Record last verified: 2017-06

Locations

NZ (1)