Osteoarthritis, KneeNCT01765699
Predicting Poor Outcomes After Primary Knee Arthroplasty
An observational study of Osteoarthritis, Knee, run by Newcastle-upon-Tyne Hospitals NHS Trust.
Trial summary
Aim To identify through data analysis key patients, surgeon and operative dependent variables which will improve the performance of knee replacement for primary osteoarthritis Research Question 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Primary knee arthroplasty
- Type of treatment
- Medical device
- How many people
- 1,300 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Feb 2013
- 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: Patients who have undergone primary knee arthroplasty in our centre.
Who may be able to join
- Primary knee arthroplasty
- Osteoarthritis
Who cannot join
- No consent for joint registry data collection
About this study
Aim To identify through data analysis key patients, surgeon and operative dependent variables which will improve the performance of knee replacement for primary osteoarthritis
Research Question
- Can the investigators identify association between outcomes and patients characteristics using existing (already collected) datasets
- What are the characteristics of patients with poor outcome after knee replacement
- What can be done to improve the outcome of patients at risk of poor results
Read the detailed description
This is a retrospective analysis of a prospectively collected single centre database.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Primary knee arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary knee arthroplastyDevice
Patients undergoing primary knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Primary knee arthroplasty | Patients with osteoarthritis of the knee undergoing primary knee arthroplasty Receives: Device: Primary knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PROMS
Measured: 1,2,3 and 5 Years post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Time perspective
- Retrospective
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Craig Gerrand, Principal investigator, Consultant Orthopaedic SurgeonDavid Deehan, Study director, Consultant Orthopaedic Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765699
- Sponsor's protocol ID
- 3878
- Status last verified
- Oct 2015
- First submitted
- 31 Dec 2012
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Poor Outcomes After Primary Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01765699
- Acronym / sponsor ID
- 3878
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- DePuy Orthopaedics
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 10 Jan 2013 (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.
Aim To identify through data analysis key patients, surgeon and operative dependent variables which will improve the performance of knee replacement for primary osteoarthritis
Research Question
- Can the investigators identify association between outcomes and patients characteristics using existing (already collected) datasets
- What are the characteristics of patients with poor outcome after knee replacement
- What can be done to improve the outcome of patients at risk of poor results
Detailed description
This is a retrospective analysis of a prospectively collected single centre database.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary knee arthroplasty | – | Device: Primary knee arthroplastyPatients with osteoarthritis of the knee undergoing primary knee arthroplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have undergone primary knee arthroplasty in our centre.
Key inclusion criteria (2 listed)
- Primary knee arthroplasty
- Osteoarthritis
Key exclusion criteria (1 listed)
- No consent for joint registry data collection
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 |
|---|---|---|
| Primary knee arthroplastyPatients undergoing primary knee arthroplasty | Device | Primary knee arthroplasty |
Primary outcome
Change in PROMS
Time frame: 1,2,3 and 5 Years post op
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 12 Oct 2015.
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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.
Craig Gerrand principal investigator
Consultant Orthopaedic Surgeon
David Deehan study director
Consultant Orthopaedic Surgeon
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Newcastle-upon-Tyne Hospitals NHS Trust.
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 2 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: finished, as of the sponsor's last update on 12 Oct 2015. 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?
Change in PROMS (time frame: 1,2,3 and 5 Years post op). 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 12 Oct 2015.