Revision Total Knee ReplacementNCT01156558
Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves
An observational study of Revision Total Knee Replacement, run by Rothman Institute Orthopaedics.
Trial summary
Metaphyseal sleeves, through their design, could allow reconstruction of the knee in cases of severe bone loss by allowing rigid internal fixation and proper alignment of the extremity and components. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Revision Total Knee Replacement
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jul 2010
- 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: Sequential assessment of 100 patients who have received a revision knee surgery for which metaphyseal sleeve was used in femoral and/or tibial side starting August 2007. Patients must meet inclusion/exclusion criteria for enrollment.
Who may be able to join
- Revision knees with bone defect for which metaphyseal sleeve in femoral and/or tibial side is used
- Cases with at least 2 year follow-up
- Cases with regular follow-up visits completed
Who cannot join
- Cemented sleeves
- Patients with less than two year follow-up completed
- Cases lost to follow-up
About this study
Metaphyseal sleeves, through their design, could allow reconstruction of the knee in cases of severe bone loss by allowing rigid internal fixation and proper alignment of the extremity and components.
- Conditions
- Revision Total Knee Replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survivorship 2 years following revision TKA
Secondary outcomes (3)
Knee Society Score
KOOS score
Radiographic assessment 1 and 2 years following revision surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Revision Total Knee ReplacementStudies 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
- Retrospective
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156558
- Sponsor's protocol ID
- 10FA01
- Status last verified
- Mar 2011
- First submitted
- 1 Jul 2010
- Last updated
- 31 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves
- ClinicalTrials.gov ID
- NCT01156558
- Acronym / sponsor ID
- 10FA01
- Conditions
- Revision Total Knee Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Collaborators
- DePuy Orthopaedics
- Study start
- Jun 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 5 Jul 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.
Metaphyseal sleeves, through their design, could allow reconstruction of the knee in cases of severe bone loss by allowing rigid internal fixation and proper alignment of the extremity and components.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sequential assessment of 100 patients who have received a revision knee surgery for which metaphyseal sleeve was used in femoral and/or tibial side starting August 2007. Patients must meet inclusion/exclusion criteria for enrollment.
Key inclusion criteria (3 listed)
- Revision knees with bone defect for which metaphyseal sleeve in femoral and/or tibial side is used
- Cases with at least 2 year follow-up
- Cases with regular follow-up visits completed
Key exclusion criteria (3 listed)
- Cemented sleeves
- Patients with less than two year follow-up completed
- Cases lost to follow-up
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
Implant survivorship 2 years following revision TKA
3 secondary outcomes
Knee Society Score
KOOS score
Radiographic assessment 1 and 2 years following revision surgery
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 31 Mar 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Revision Total Knee Replacement, run by Rothman Institute Orthopaedics.
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 3 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 31 Mar 2011. 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 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?
Implant survivorship 2 years following revision TKA. 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 31 Mar 2011.