Joint DiseasesNCT03986918
Survivorship and Patient Outcomes of Primary Total Hip Arthroplasty With the Ovation Hip System
An observational study of Joint Diseases and Osteoarthritis, Hip, run by Ortho Development Corporation at 1 site in United States.
Trial summary
The objective of this study is to evaluate patient outcomes in regards to safety and effectiveness based on the clinical performance of the reference devices to further support the assessment of residual risk identified in the Clinical Evaluation Report for the Ortho Development Hip System. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Joint Diseases, Osteoarthritis, Hip, Rheumatoid Arthritis
- What is being tested?
- Routine Total Hip Arthroplasty
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 30 Jun 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Identification will occur from a list of patients having undergone total hip arthroplasty at Straub Medical Center between 2012 and the end of December 2015. Identified patients will then be screened for eligibility criteria
Who may be able to join
- Patient is at least 18 years of age
- Patient is five years post total hip arthroplasty
- Patient received the Ovation® or Ovation Tribute® femoral stem with associated acetabular and femoral components
- Patient agrees to participate in the survey.
Who cannot join
- Patient does not have the Ovation® or Ovation Tribute® femoral stem with associated acetabular and femoral components
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Straub Medical Center
Honolulu, Hawaii, 96813
Samantha Andrews, PhD, 808-522-4855, samantha.andrews@straub.net
About this study
The objective of this study is to evaluate patient outcomes in regards to safety and effectiveness based on the clinical performance of the reference devices to further support the assessment of residual risk identified in the Clinical Evaluation Report for the Ortho Development Hip System.
Read the detailed description
Long term surveillance of survivorship and complications can help to identify pre-surgical comorbidities, perhaps leading to a lower risk of implant failure and subsequent revision surgery. By understanding the role of comorbidities in the specific population, it is possible to increase patient outcomes and satisfaction, while reducing the costs associated with complications and revision surgeries.
This study consists of prospective collection and analysis of data for a consecutive series of patients that underwent total hip arthroplasty with the Ortho Development Ovation® Hip System at the study site between 2012 and December 2015. It is estimated that over 400 patients received the subject system. Each of these patients will receive a survey within the mail when they approach, or have exceeded, their five-year post-surgical time period.
- Conditions
- Joint Diseases, Osteoarthritis, Hip, Rheumatoid Arthritis, Psoriatic Arthritis, Avascular Necrosis of Hip
- Being tested
- Routine Total Hip Arthroplasty
- Medical subject headings
- Joint Diseases, Osteoarthritis, Hip, Arthritis, Rheumatoid, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Total Hip ArthroplastyDevice
Patients undergoing routine total hip arthroplasty will receive surveys regarding survivorship and outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Ovation and Ovation Tribute | All patients having undergone a total hip arthroplasty that received the Ovation® or Ovation Tribute® (Ortho Development, Draper, Utah) Hip system will be sent the survey. Receives: Device: Routine Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship - The number of revision surgeries over time.
The primary outcome will be 5-10 year survivorship of implant components, with failure defined as revision of any component.
Measured: 5 - 10-year follow-up
Secondary outcomes (3)
Pain and Function
The Hip Disability and Osteoarthritis Outcome score - joint replacement (HOOS JR) will be used. The HOOS-JR is a joint replacement survey designed to measure pain and function.
Measured: 5 - 10 year follow-up
General Health
The Veterans Rand - 12 (VR-12) will be used to measure general health, including the ability to carry out usual activities.
Measured: 5 - 10 year follow-up
Patient satisfaction.
A four question patient satisfaction survey will be used to measure the patient's satisfaction with their surgery, pain control, function, and ability to participate in recreational activities.
Measured: 5 - 10 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Jun 2019
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ortho Development Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cass Nakasone, MD, Principal investigator, Hawai'i Pacific Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986918
- Sponsor's protocol ID
- P-17-0013B
- Status last verified
- Jun 2019
- First submitted
- 7 Jun 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivorship and Patient Outcomes of Primary Total Hip Arthroplasty With the Ovation Hip System
- ClinicalTrials.gov ID
- NCT03986918
- Acronym / sponsor ID
- P-17-0013B
- Conditions
- Joint Diseases, Osteoarthritis, Hip, Rheumatoid Arthritis, Psoriatic Arthritis, Avascular Necrosis of Hip
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ortho Development CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 14 Jun 2019 (actual)
- 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.
The objective of this study is to evaluate patient outcomes in regards to safety and effectiveness based on the clinical performance of the reference devices to further support the assessment of residual risk identified in the Clinical Evaluation Report for the Ortho Development Hip System.
Detailed description
Long term surveillance of survivorship and complications can help to identify pre-surgical comorbidities, perhaps leading to a lower risk of implant failure and subsequent revision surgery. By understanding the role of comorbidities in the specific population, it is possible to increase patient outcomes and satisfaction, while reducing the costs associated with complications and revision surgeries.
This study consists of prospective collection and analysis of data for a consecutive series of patients that underwent total hip arthroplasty with the Ortho Development Ovation® Hip System at the study site between 2012 and December 2015. It is estimated that over 400 patients received the subject system. Each of these patients will receive a survey within the mail when they approach, or have exceeded, their five-year post-surgical time period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovation and Ovation Tribute | – | Device: Routine Total Hip ArthroplastyAll patients having undergone a total hip arthroplasty that received the Ovation® or Ovation Tribute® (Ortho Development, Draper, Utah) Hip system will be sent the survey. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Identification will occur from a list of patients having undergone total hip arthroplasty at Straub Medical Center between 2012 and the end of December 2015. Identified patients will then be screened for eligibility criteria
Key inclusion criteria (4 listed)
- Patient is at least 18 years of age
- Patient is five years post total hip arthroplasty
- Patient received the Ovation® or Ovation Tribute® femoral stem with associated acetabular and femoral components
- Patient agrees to participate in the survey.
Key exclusion criteria (1 listed)
- Patient does not have the Ovation® or Ovation Tribute® femoral stem with associated acetabular and femoral components
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 |
|---|---|---|
| Routine Total Hip ArthroplastyPatients undergoing routine total hip arthroplasty will receive surveys regarding survivorship and outcomes. | Device | Ovation and Ovation Tribute |
Primary outcome
Survivorship - The number of revision surgeries over time.
Time frame: 5 - 10-year follow-up
The primary outcome will be 5-10 year survivorship of implant components, with failure defined as revision of any component.
3 secondary outcomes
Pain and Function
Time frame: 5 - 10 year follow-up
General Health
Time frame: 5 - 10 year follow-up
Patient satisfaction.
Time frame: 5 - 10 year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Cass Nakasone, MD principal investigator
Hawai'i Pacific Health
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 Joint Diseases and Osteoarthritis, Hip, run by Ortho Development Corporation 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 1 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: status not confirmed, as of the sponsor's last update on 14 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samantha Andrews, PhD (8085224822, samantha.andrews@straub.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship - The number of revision surgeries over time. (time frame: 5 - 10-year follow-up). 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 14 Jun 2019; AzTrials last refreshed its copy on 8 Nov 2026.