Measurement of Early Bone Loss Around a Total Hip Arthroplasty (DXACorail)

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01046019
First received: January 8, 2010
Last updated: July 3, 2011
Last verified: January 2010
  Purpose

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.


Condition
Coxarthrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Early Bone Loss Around a Total Hip Arthroplasty. A Prospective Trial With Dual Energy X-ray Absorptiometry.

Further study details as provided by Oslo University Hospital:

Enrollment: 23
Study Start Date: September 2007
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with degenerative hip osteoarthritis decided for operation with total hip arthroplasty.

Criteria

Inclusion Criteria:

  • degenerative hip osteoarthritis

Exclusion Criteria:

  • metastasis to bone
  • dementia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046019

Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Study Director: Lars Nordsletten, Professor Ullevaal University Hospital
Principal Investigator: Berte G Bøe, MD Ullevaal University Hospital
  More Information

No publications provided

Responsible Party: Berte Bøe, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01046019     History of Changes
Other Study ID Numbers: 35-07122b 1.2007.896
Study First Received: January 8, 2010
Last Updated: July 3, 2011
Health Authority: Norway: Ethics Committee

Keywords provided by Oslo University Hospital:
DXA
Hip
Arthroplasty

Additional relevant MeSH terms:
Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 22, 2014