Complications; Arthroplasty, MechanicalNCT01245478
DePuy Revision TKA Implant 5yr Survivorship
An observational study of Complications; Arthroplasty, Mechanical, run by The New England Baptist Hospital.
Trial summary
This will be a retrospective chart review of 200 charts of adult patients who have undergone a revision TKA at New England Baptist Hospital and who received implant component(s) manufactured by DePuy Orthopedics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complications; Arthroplasty, Mechanical
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Jul 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any NEBH patients who received DePuy implant components during a Revision TKA procedure, performed by either: * Dr. Geoffrey Van Flandern * Dr. David Mattingly * Dr. James Nairus * Dr. James Bono * Dr. Daniel Ward * Dr. Carl Talmo
Who may be able to join
- Received a Revision TKA (must have been initial revision)
- --Received J\&J/DePuy implant components for initial revision
- Procedure performed at New England Baptist Hospital
Who cannot join
- 2nd Revision TKA on knee
- Received femoral or tibial components not of DePuy manufacture
About this study
Official title: Clinical Outcome and 5-year Implant Survival Rate Among Adult Revision Total Knee Arthroplasty Patients With DePuy Implant Components
This will be a retrospective chart review of 200 charts of adult patients who have undergone a revision TKA at New England Baptist Hospital and who received implant component(s) manufactured by DePuy Orthopedics. The data will be collected retrospectively after patients are seen clinically for a minimum of five years after surgery to answer:
- What is the five-year survivorship of revision a knee prosthesis containing components manufactured by DePuy Orthopedics among adult revision TKA patients?
- What patient factors are associated with the need for re-operation after revision TKA among patients receiving DePuy implant components? How do clinical outcomes change from baseline over the five-year follow-up after revision TKA surgery?
Data collection will include patient-reported and clinician-reported measures.
- Conditions
- Complications; Arthroplasty, Mechanical
- Keywords
- Surgical Procedures, Elective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Retrospective record review only (no subject enrollment). Contract never executed between Sponsor and Site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Arthroplasty, MechanicalStudies 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
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The New England Baptist Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Depuy, Inc.
- Responsible party
- Sponsor
- Investigators
- John Richmond, MD, Principal investigator, New England Baptist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245478
- Sponsor's protocol ID
- IIS-000105
- Status last verified
- Apr 2013
- First submitted
- 19 Nov 2010
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome and 5-year Implant Survival Rate Among Adult Revision Total Knee Arthroplasty Patients With DePuy Implant Components
- ClinicalTrials.gov ID
- NCT01245478
- Acronym / sponsor ID
- IIS-000105
- Conditions
- Complications; Arthroplasty, Mechanical
- Keywords
- Surgical Procedures, Elective
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Retrospective record review only (no subject enrollment). Contract never executed between Sponsor and Site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The New England Baptist HospitalUniversity, hospital or other
- Collaborators
- Depuy, Inc.
- Study start
- Nov 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 Nov 2010 (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 will be a retrospective chart review of 200 charts of adult patients who have undergone a revision TKA at New England Baptist Hospital and who received implant component(s) manufactured by DePuy Orthopedics. The data will be collected retrospectively after patients are seen clinically for a minimum of five years after surgery to answer:
- What is the five-year survivorship of revision a knee prosthesis containing components manufactured by DePuy Orthopedics among adult revision TKA patients?
- What patient factors are associated with the need for re-operation after revision TKA among patients receiving DePuy implant components? How do clinical outcomes change from baseline over the five-year follow-up after revision TKA surgery?
Data collection will include patient-reported and clinician-reported measures.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any NEBH patients who received DePuy implant components during a Revision TKA procedure, performed by either: * Dr. Geoffrey Van Flandern * Dr. David Mattingly * Dr. James Nairus * Dr. James Bono * Dr. Daniel Ward * Dr. Carl Talmo
Key inclusion criteria (3 listed)
- Received a Revision TKA (must have been initial revision)
- --Received J\&J/DePuy implant components for initial revision
- Procedure performed at New England Baptist Hospital
Key exclusion criteria (2 listed)
- 2nd Revision TKA on knee
- Received femoral or tibial components not of DePuy manufacture
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 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.
John Richmond, MD principal investigator
New England Baptist Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Complications; Arthroplasty, Mechanical, run by The New England Baptist Hospital.
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 2 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: withdrawn, as of the sponsor's last update on 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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.
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 1 May 2013.