Measurement of Early Bone Loss Around a Total Hip Arthroplasty

Coxarthrosis Clinical Trial

— DXACorail  

Official title:

Measurement of Early Bone Loss Around a Total Hip Arthroplasty. A Prospective Trial With Dual Energy X-ray Absorptiometry.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046019
• Other study ID #: 35-07122b 1.2007.896
• Status: Completed
• Phase: N/A
• First received: January 8, 2010
• Last updated: July 3, 2011
• Start date: September 2007
• Est. completion date: August 2009

Study information

• Verified date: January 2010
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Research with DXA has shown the pattern of bone remodelling around an implant. The baseline and reference value for such calculations is the first measurement after the operation. The baseline measurement is performed at different time from study to study. If there is a rapid bone loss the first weeks after an operation, this will influence the reference value and then the results. To evaluate DXA as a method we decided to set up a study with 3 DXA measurements within the first 2 weeks. Our hypothesis is that there is a rapid bone loss the first 2 weeks after operation and that timing of the first post operative measurement will influence the later results.

Description:

Dual x-ray absorptiometry (DXA) has become the most used and proven to be a precise method to investigate changes in bone mass density (BMD). Research with DXA has shown the pattern of bone remodelling around an implant. Results from implant studies are often presented as changes in BMD as a function of time. The baseline and reference value for such calculations is the first measurement after the operation. The most pronounced bone loss after implantation of hip prosthesis usually comes within 3 months. The baseline measurement is performed at different time from study to study. If there is a rapid bone loss the first weeks after an operation, this will influence the reference value and then the results. To evaluate DXA as a method we decided to set up a study with 3 DXA measurements within the first 2 weeks.

We included 23 patients operated with total hip prosthesis (THP). They were measured with DXA at 1, 5 and 14 days, 3 and 12 months after the operation. Results were given in percent (+/-SD) for each Gruen zone. There were no changes in bone density between the first 3 measurements. In all zones, except zone 1, the lowest BMD was measured after 3 months. We concluded that DXA measurements done within 14 days after the operation can be used as reference measurements for later follow ups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• degenerative hip osteoarthritis

Exclusion Criteria:

• metastasis to bone

• dementia

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coxarthrosis
• Osteoarthritis, Hip

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ullevaal University Hospital