OsteoarthritisNCT02467764
"Score Infectivity" During Reoperation on Total Hip or Knee Prosthesis
An observational study of Osteoarthritis, run by University Hospital, Strasbourg, France.
Trial summary
The hip or knee is a validated treatment of end-stage osteoarthritis, and these interventions commonly make a significant improvement in the quality of life of patients. Infection can occur in 1-5% of cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Retrospective study
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to May 2016
- 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: Patients operated in the service in 2014 to care for end-stage hip or knee osteoarthritis by implantation of a total hip or knee prosthesis.
Who may be able to join
- Patients over 18 years
- Patients operated in the service in 2014 to care for end-stage hip or knee osteoarthritis by implantation of a total hip or knee prosthesis.
Who cannot join
- Patients under 18 years
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Definition of a "Score Infectivity" During Reoperation on Total Hip or Knee Prosthesis
The hip or knee is a validated treatment of end-stage osteoarthritis, and these interventions commonly make a significant improvement in the quality of life of patients. Infection can occur in 1-5% of cases. Diagnosis is often difficult, but the knowledge of infected or not infected character directly influences the surgical conduct. It is therefore recommended that the positive or negative diagnosis is made in the most reliable way possible, but no single element only allows a low diagnosis. The concomitant use of several clinical, radiological and aggregated into a composite score history could help facilitate this preoperative approach during reoperation on prosthetic joint
- Conditions
- Osteoarthritis
- Being tested
- Retrospective study
- Keywords
- Knee, Knee osteoarthritis, Knee replacement, Hip, Hip osteoarthritis, Hip replacement
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
define a composite score on total Hip or Knee Prosthesis
Measured: patient's medical data will be collected by health professional for the duration hospital stay, up to 1 year]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Yves JENNY, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467764
- Sponsor's protocol ID
- 2015-20
- Status last verified
- Jun 2015
- First submitted
- 14 May 2015
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definition of a "Score Infectivity" During Reoperation on Total Hip or Knee Prosthesis
- ClinicalTrials.gov ID
- NCT02467764
- Acronym / sponsor ID
- 2015-20
- Conditions
- Osteoarthritis
- Keywords
- Knee, Knee osteoarthritis, Knee replacement, Hip, Hip osteoarthritis, Hip replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 10 Jun 2015 (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.
The hip or knee is a validated treatment of end-stage osteoarthritis, and these interventions commonly make a significant improvement in the quality of life of patients. Infection can occur in 1-5% of cases. Diagnosis is often difficult, but the knowledge of infected or not infected character directly influences the surgical conduct. It is therefore recommended that the positive or negative diagnosis is made in the most reliable way possible, but no single element only allows a low diagnosis. The concomitant use of several clinical, radiological and aggregated into a composite score history could help facilitate this preoperative approach during reoperation on prosthetic joint
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated in the service in 2014 to care for end-stage hip or knee osteoarthritis by implantation of a total hip or knee prosthesis.
Key inclusion criteria (2 listed)
- Patients over 18 years
- Patients operated in the service in 2014 to care for end-stage hip or knee osteoarthritis by implantation of a total hip or knee prosthesis.
Key exclusion criteria (1 listed)
- Patients under 18 years
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 |
|---|---|---|
| Retrospective study | Other | – |
Primary outcome
define a composite score on total Hip or Knee Prosthesis
Time frame: patient's medical data will be collected by health professional for the duration hospital stay, up to 1 year]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
Related trials for Osteoarthritis
Recruiting
Oral Nutritional Optimization in Total Joint Arthroplasty
Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
Not yet recruiting
Hybrid Closed Wedge High Tibial Osteotomy
Patello-femoral Osteoarthritis
Recruiting
Effects of Graded Motor Imagery in Individuals With Foot/Ankle Osteoarthritis
Ankle Osteoarthritis, Foot Osteoarthritis
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.
Jean-Yves JENNY, MD principal investigator
University Hospital, Strasbourg, France
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by University Hospital, Strasbourg, France.
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: status not confirmed, as of the sponsor's last update on 10 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Yves JENNY, MD (33.3.88.55.21.45, jean-yves.jenny@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
define a composite score on total Hip or Knee Prosthesis (time frame: patient's medical data will be collected by health professional for the duration hospital stay, up to 1 year]). 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 10 Jun 2015.