Osteoarthritis, HipNCT01359527
Dual Energy X-ray Absorptiometry (DXA) Comparison Hip Resurfacing Versus Total Hip Arthroplasty (THA)
An observational study of Osteoarthritis, Hip, run by Spokane Joint Replacement Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Hip Resurfacing and Total Hip Arthroplasty
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients undergoing hip replacement or resurfacing for osteoarthritis
Who may be able to join
- Age of at least 20 years
- Osteoarthritis
- Elective Total Hip Arthroplasty / Resurfacing
- Signed Informed Consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Spokane Joint Replacement Center
Spokane, Washington, 99218
About this study
Official title: A Dual Energy X-Ray Absorptiometry Comparison Of Periprosthetic Bone Loss Between Patients Undergoing Hip Resurfacing Surgery And Total Hip Arthroplasty
This study compares the change (loss) of bone mineral density (BMD) that occurs in the proximal femur after hip resurfacing and total hip replacement.
Read the 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.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Hip Resurfacing, Total Hip Arthroplasty
- Keywords
- Total Hip Replacement, Hip Resurfacing, Femoral Remodeling, Bone Loss, Bone Mineral Density, BMD, DXA, DEXA, THA
- Medical subject headings
- Osteoarthritis, Hip, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip ResurfacingDevice
Total Hip ArthroplastyDevice
| Study group | Role | What they receive |
|---|---|---|
| Hip Resurfacing | Not described Receives: Device: Hip Resurfacing | |
| Total Hip Arthroplasty | Not described Receives: Device: Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Secondary outcomes (1)
Harris Hip Score
Hip functional outcomes will be assessed using the Harris Hip Score
Measured: Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startDec 2008
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spokane Joint Replacement Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David F. Scott, MD, Spokane Joint Replacement Center
- Investigators
- David Scott, MD, Principal investigator, Spokane Joint Replacement Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359527
- Sponsor's protocol ID
- SJRC-RSRF
- Status last verified
- Apr 2019
- First submitted
- 22 May 2011
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dual Energy X-Ray Absorptiometry Comparison Of Periprosthetic Bone Loss Between Patients Undergoing Hip Resurfacing Surgery And Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01359527
- Acronym / sponsor ID
- SJRC-RSRF
- Conditions
- Osteoarthritis, Hip
- Keywords
- Total Hip Replacement, Hip Resurfacing, Femoral Remodeling, Bone Loss, Bone Mineral Density, BMD, DXA, DEXA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Spokane Joint Replacement CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 24 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip Resurfacing | – | Device: Hip Resurfacing |
| Total Hip Arthroplasty | – | Device: Total Hip Arthroplasty |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing hip replacement or resurfacing for osteoarthritis
Key inclusion criteria (4 listed)
- Age of at least 20 years
- Osteoarthritis
- Elective Total Hip Arthroplasty / Resurfacing
- Signed Informed Consent
Key exclusion criteria (9 listed)
- Osteoporosis
- Revisions
- Femoral dysplasia
- Trochanteric osteotomy
- Inflammatory arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip Resurfacing | Device | Hip Resurfacing |
| Total Hip Arthroplasty | Device | Total Hip Arthroplasty |
Primary outcome
Bone Mineral Density
Time frame: 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.
1 secondary outcome
Harris Hip Score
Time frame: Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Scott, MD principal investigator
Spokane Joint Replacement Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip, run by Spokane Joint Replacement Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (time frame: Baseline, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.