Osteoarthritis of the HipNCT00951145
Medium and Long Term Outcome of Total Hip Arthroplasty Using Accolade TMZF Femoral Stem
An observational study of Osteoarthritis of the Hip, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
This is a retrospective/prospective study evaluating the clinical and radiographic outcome of total hip arthroplasty (THA) performed using Accolade femoral stem in a consecutive group of patients. All patients eligible for inclusion will be identified. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis of the Hip
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients undergoing THA prior to 1/1/2003 using Accolade femoral stem
Who may be able to join
- All patients undergoing THA prior to 1/1/2003 using Accolade femoral stem.
- Patients with hip fracture undergoing THA will also be included.
- Patients willing and able to comply with follow-up requirements and self-evaluations.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This is a retrospective/prospective study evaluating the clinical and radiographic outcome of total hip arthroplasty (THA) performed using Accolade femoral stem in a consecutive group of patients. All patients eligible for inclusion will be identified. The investigators hypothesize that the outcome of THA performed using Accolade femoral stem is equal or superior to historical survivorship of THA using other types of collarless, proximally coated, tapered stems.
- Conditions
- Osteoarthritis of the Hip
- Medical subject headings
- Osteoarthritis, Hip
What is being measured
The primary outcome is the main question the study is designed to answer.
The outcome of THA performed using Accolade femoral stem is equal or superior to historical survivorship of THA using other types of collarless, proximally coated, tapered stem
Secondary outcomes (1)
Proximally coated tapered stems can be used for patients with various bone types, bone morphology, and underlying diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the 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 only
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Orthopaedics
- Investigators
- Parvizi Javad, MD, Principal investigator, Rothman InstituteHozack William, MD, Principal investigator, Rothman Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951145
- Sponsor's protocol ID
- RIFJPAR 09-01
- Status last verified
- Apr 2013
- First submitted
- 31 Jul 2009
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium and Long Term Outcome of Total Hip Arthroplasty Using Accolade TMZF Femoral Stem
- ClinicalTrials.gov ID
- NCT00951145
- Acronym / sponsor ID
- RIFJPAR 09-01
- Conditions
- Osteoarthritis of the Hip
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics
- First posted
- 4 Aug 2009 (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 is a retrospective/prospective study evaluating the clinical and radiographic outcome of total hip arthroplasty (THA) performed using Accolade femoral stem in a consecutive group of patients. All patients eligible for inclusion will be identified. The investigators hypothesize that the outcome of THA performed using Accolade femoral stem is equal or superior to historical survivorship of THA using other types of collarless, proximally coated, tapered stems.
Study design
- Observational model
- Case only
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing THA prior to 1/1/2003 using Accolade femoral stem
Key inclusion criteria (3 listed)
- All patients undergoing THA prior to 1/1/2003 using Accolade femoral stem.
- Patients with hip fracture undergoing THA will also be included.
- Patients willing and able to comply with follow-up requirements and self-evaluations.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The outcome of THA performed using Accolade femoral stem is equal or superior to historical survivorship of THA using other types of collarless, proximally coated, tapered stem
1 secondary outcome
Proximally coated tapered stems can be used for patients with various bone types, bone morphology, and underlying diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
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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.
Parvizi Javad, MD principal investigator
Rothman Institute
Hozack William, MD principal investigator
Rothman Institute
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 of the Hip, run by Rothman Institute Orthopaedics 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 3 inclusion and 0 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 9 Apr 2013. 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?
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?
The outcome of THA performed using Accolade femoral stem is equal or superior to historical survivorship of THA using other types of collarless, proximally coated, tapered stem. 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 9 Apr 2013.