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

Completed

• Conditions: Osteoarthritis, Hip
• Interventions: Device: Hip Resurfacing; Device: Total Hip Arthroplasty

• Registration Number: NCT01359527
• Lead Sponsor: Spokane Joint Replacement Center

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.

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 Timeline

• Study Start: 2008-12
• Study First Submitted: 2011-05-22
• Study First Submitted QC: 2011-05-23
• Study First Posted: 2011-05-24
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hip Resurfacing	Hip Resurfacing	-
Total Hip Arthroplasty	Total Hip Arthroplasty	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Spokane Joint Replacement Center; 🇺🇸 Spokane, Washington, United States