Measurement of Early Bone Loss Around a Total Hip Arthroplasty (DXACorail)
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|ClinicalTrials.gov Identifier: NCT01046019|
Recruitment Status : Completed
First Posted : January 11, 2010
Last Update Posted : July 6, 2011
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||23 participants|
|Official Title:||Measurement of Early Bone Loss Around a Total Hip Arthroplasty. A Prospective Trial With Dual Energy X-ray Absorptiometry.|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||August 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046019
|Study Director:||Lars Nordsletten, Professor||Ullevaal University Hospital|
|Principal Investigator:||Berte G Bøe, MD||Ullevaal University Hospital|