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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359527
• Other study ID #: SJRC-RSRF
• Status: Completed
• Start date: December 2008
• Est. completion date: November 2018

Study information

• Verified date: April 2019
• Source: Spokane Joint Replacement Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• Hip Resurfacing

• Total Hip Arthroplasty

Locations

Country	Name	City	State
United States	Spokane Joint Replacement Center	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Spokane Joint Replacement Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density	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.	Baseline, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Secondary	Harris Hip Score	Hip functional outcomes will be assessed using the Harris Hip Score	Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative