Dual Energy X-ray Absorptiometry (DXA) Comparison Hip Resurfacing Versus Total Hip Arthroplasty (THA)

Sponsor

Spokane Joint Replacement Center (Other)

Overall Status

Completed

CT.gov ID

NCT01359527

Collaborator

(none)

Enrollment

Location

119

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study compares the change (loss) of bone mineral density (BMD) that occurs in the proximal femur after hip resurfacing and total hip replacement.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Hip	Device: Hip Resurfacing Device: Total Hip Arthroplasty

Detailed Description

This study compares the change (loss) of bone mineral density (BMD) that occurs in the proximal femur after hip resurfacing and total hip replacement. The goal is to evaluate the bone loss in the proximal femur resulting from hip resurfacing surgery and to compare this to the bone loss in the proximal femur resulting from total hip arthroplasty.

Study Design

Study Type:

Observational

Actual Enrollment :

31 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

A Dual Energy X-Ray Absorptiometry Comparison Of Periprosthetic Bone Loss Between Patients Undergoing Hip Resurfacing Surgery And Total Hip Arthroplasty

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Nov 1, 2018

Actual Study Completion Date :

Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Hip Resurfacing	Device: Hip Resurfacing
Total Hip Arthroplasty	Device: Total Hip Arthroplasty

Arm

Intervention/Treatment

Hip Resurfacing

Device: Hip Resurfacing

Total Hip Arthroplasty

Device: Total Hip Arthroplasty

Outcome Measures

Primary Outcome Measures

Bone Mineral Density [Baseline, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative]
To evaluate the bone loss in the proximal femur resulting from hip resurfacing surgery and to compare this to the bone loss in the proximal femur resulting from total hip arthroplasty.

Secondary Outcome Measures

Harris Hip Score [Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative]
Hip functional outcomes will be assessed using the Harris Hip Score

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age of at least 20 years
Osteoarthritis
Elective Total Hip Arthroplasty / Resurfacing
Signed Informed Consent

Exclusion Criteria:

Osteoporosis
Revisions
Femoral dysplasia
Trochanteric osteotomy
Inflammatory arthritis
Breast-feeding, pregnancy, or women of child-bearing potential without documentation of a negative pregnancy test and not utilizing contraception
Patients with a history of having taken or currently taking PTH, fluoride therapy or strontium ranelate or patients taking other chronic medications that in the Investigator's opinion are known to affect bone mineral density in a substantial way
Patients with severe medical condition(s) that in the view of the Investigator prohibits participation in the study
Use of any other investigational agent in the last 30 days