Osteoarthritis, HipNCT01359540
Femoral Remodeling Following Total Hip Arthroplasty With OMNI Apex Modular™ and OMNI Apex ARC™ Stem Compared to Competitive Designs
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 in bone density which occurs after hip replacement with different femoral stem devices. 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?
- OMNI Apex Modular™ Hip Device and OMNI Apex ARC™ Hip Device
- Type of treatment
- Medical device
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Apr 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 elective total hip arthroplasty
Who may be able to join
- Minimum age 20 years, maximum age 80 years
- Osteoarthritis of the hip
- Elective THA
- Signed Informed Consent
Who cannot join
- Osteoporosis
- Revisions
- Clinically obese (>40 body mass index [BMI])
- Femoral dysplasia
- Trochanteric osteotomy
- Inflammatory arthritis
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- Breast-feeding, pregnancy, or women of childbearing potential without documentation of a negative pregnancy test and not utilizing contraception
- Patients with a history of having taken or currently taking bisphosphonates, 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 other investigational agent in the last 30 days
- Unable to sign Informed Consent
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 (DXA) Evaluation Of Bone Density Changes After Hip Replacement. Performance Of The OMNI Apex Modular™ Hip Stem And The OMNI Apex ARC™ Hip Stem In Primary Total Hip Arthroplasty, Five-Year Clinical And DXA Analysis
This study compares the change in bone density which occurs after hip replacement with different femoral stem devices.
- Conditions
- Osteoarthritis, Hip
- Being tested
- OMNI Apex Modular™ Hip Device, OMNI Apex ARC™ Hip Device
- Keywords
- Total Hip Arthroplasty, Bone Loss, Femoral Remodeling, Bone mineral density, THA, DXA, DEXA, Dual Energy X-Ray Absorptiometry
- 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.
OMNI Apex Modular™ Hip DeviceDevice
OMNI Apex ARC™ Hip DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| APEX Modular | APEX Modular Stem group Receives: Device: OMNI Apex Modular™ Hip Device | |
| ARC Stem | ARC Stem group Receives: Device: OMNI Apex ARC™ Hip Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral bone mineral density
Change in bone mineral density (BMD) as measured by DXA imaging.
Measured: Baseline, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Secondary outcomes (1)
Harris Hip Score (HHS)
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 startNov 2009
- Primary completionApr 2018
- Study completionApr 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
- 73 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 F Scott, MD, Principal investigator, Spokane Joint Replacement Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359540
- Sponsor's protocol ID
- SJRC-OMNH
- 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 (DXA) Evaluation Of Bone Density Changes After Hip Replacement. Performance Of The OMNI Apex Modular™ Hip Stem And The OMNI Apex ARC™ Hip Stem In Primary Total Hip Arthroplasty, Five-Year Clinical And DXA Analysis
- ClinicalTrials.gov ID
- NCT01359540
- Acronym / sponsor ID
- SJRC-OMNH
- Conditions
- Osteoarthritis, Hip
- Keywords
- Total Hip Arthroplasty, Bone Loss, Femoral Remodeling, Bone mineral density, THA, DXA, DEXA, Dual Energy X-Ray Absorptiometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Spokane Joint Replacement CenterUniversity, hospital or other
- Study start
- Nov 2009 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 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 in bone density which occurs after hip replacement with different femoral stem devices.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APEX Modular | – | Device: OMNI Apex Modular™ Hip DeviceAPEX Modular Stem group |
| ARC Stem | – | Device: OMNI Apex ARC™ Hip DeviceARC Stem group |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective total hip arthroplasty
Key inclusion criteria (4 listed)
- Minimum age 20 years, maximum age 80 years
- Osteoarthritis of the hip
- Elective THA
- Signed Informed Consent
Key exclusion criteria (11 listed)
- Osteoporosis
- Revisions
- Clinically obese (>40 body mass index [BMI])
- Femoral dysplasia
- Trochanteric osteotomy
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 |
|---|---|---|
| OMNI Apex Modular™ Hip Device | Device | APEX Modular |
| OMNI Apex ARC™ Hip Device | Device | ARC Stem |
Primary outcome
Femoral bone mineral density
Time frame: Baseline, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Change in bone mineral density (BMD) as measured by DXA imaging.
1 secondary outcome
Harris Hip Score (HHS)
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 F 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 11 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?
Femoral 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.