TKA InfectionNCT02856971
Knee Hinge Prosthesis Following TKA Infection
An observational study of TKA Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Between 2009 and January 2016, the investigators included 49 patients from four hospitals in Lyon who had a Total Knee Arthroplasty (TKA) infection and who benefited of a knee arthroplasty revision with a rotating hinge prosthesis. Read more about this study
- Who is it for?
- Ages 45 to 91 years
- Conditions the study is for
- TKA Infection
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to May 2018
- 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 45 to 91 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having a hinge knee prosthesis following an infection on a total knee prosthesis . Pre-operative characteristics studied : Clinical characteristics : medical and surgical history on the index knee included the strategy of the infection treatment (one step treatment vs two steps treatment)and general contributing factors of infection, frontal laxity, join motions, initial constraint of the infected TKA, skin condition ( skin necrosis, fistula, flap need, scar condition) paraclinical characteristics : bone defects, condition of knee extensor system ( continuance, height of patella, joint space height (when possible to measure)), prosthethic sealing or unsealing on CT-scan or scintigraphy, causal germ(s)
Who may be able to join
- All the patients who had a rotating hinge knee arthroplasty for septic revision after total knee arthroplasty, proved by bacteriological samples or purulent drainage at involved site or other obvious clinical signs or radiological signs of infection
Who cannot join
- Patients who benefited of a hinge prosthesis following a unicompartmental prosthesis, following a mechanical issue on a total prosthesis
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de reference des infections ostéo-articulaires de Lyon,Groupement Hospitalier Nord - Hôpital de la Croix-Rousse - Bât. B, niveau 3 103 Grande-Rue de la Croix-Rousse
Lyon, 69317
About this study
Official title: Rotating Hinge Knee Arthroplasty for Septic Revision After Total Knee Arthroplasty: a Retrospective Cohort About 50 Patients With 2 Years Follow up
Between 2009 and January 2016, the investigators included 49 patients from four hospitals in Lyon who had a Total Knee Arthroplasty (TKA) infection and who benefited of a knee arthroplasty revision with a rotating hinge prosthesis. This retrospective and descriptive cohort aims at studying the functional results after 2 years follow up.
- Conditions
- TKA Infection
- Keywords
- Hinge Knee Prosthesis, TKA infection, rotating hinge prosthesis, hinge knee arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
functional results
Objective functional results : joint motions (Physician assessment)
Measured: at two years follow up
functional results
Subjective functional results : satisfaction, patient expectations, functional activities. These items are based on the new IKS score
Measured: at two years follow up
Secondary outcomes (1)
infection control
presence or absence of clinical and/or biological signs of infection, recurrence of the infection or new secondary infection
Measured: after 2 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TKA InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tristan Ferry, Pr, MD PhD, Principal investigator, Hôpital de la Croix-Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856971
- Sponsor's protocol ID
- 69HCL16_0522
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotating Hinge Knee Arthroplasty for Septic Revision After Total Knee Arthroplasty: a Retrospective Cohort About 50 Patients With 2 Years Follow up
- ClinicalTrials.gov ID
- NCT02856971
- Acronym / sponsor ID
- 69HCL16_0522
- Conditions
- TKA Infection
- Keywords
- Hinge Knee Prosthesis, TKA infection, rotating hinge prosthesis, hinge knee arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2018 (estimated)
- First posted
- 5 Aug 2016 (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.
Between 2009 and January 2016, the investigators included 49 patients from four hospitals in Lyon who had a Total Knee Arthroplasty (TKA) infection and who benefited of a knee arthroplasty revision with a rotating hinge prosthesis. This retrospective and descriptive cohort aims at studying the functional results after 2 years follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 45 to 91 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having a hinge knee prosthesis following an infection on a total knee prosthesis . Pre-operative characteristics studied : Clinical characteristics : medical and surgical history on the index knee included the strategy of the infection treatment (one step treatment vs two steps treatment)and general contributing factors of infection, frontal laxity, join motions, initial constraint of the infected TKA, skin condition ( skin necrosis, fistula, flap need, scar condition) paraclinical characteristics : bone defects, condition of knee extensor system ( continuance, height of patella, joint space height (when possible to measure)), prosthethic sealing or unsealing on CT-scan or scintigraphy, causal germ(s)
Key inclusion criteria (1 listed)
- All the patients who had a rotating hinge knee arthroplasty for septic revision after total knee arthroplasty, proved by bacteriological samples or purulent drainage at involved site or other obvious clinical signs or radiological signs of infection
Key exclusion criteria (1 listed)
- Patients who benefited of a hinge prosthesis following a unicompartmental prosthesis, following a mechanical issue on a total prosthesis
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
functional results
Time frame: at two years follow up
Objective functional results : joint motions (Physician assessment)
functional results
Time frame: at two years follow up
Subjective functional results : satisfaction, patient expectations, functional activities. These items are based on the new IKS score
1 secondary outcome
infection control
Time frame: after 2 years follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Related InfoLink provided by the sponsor.
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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.
Tristan Ferry, Pr, MD PhD principal investigator
Hôpital de la Croix-Rousse
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 TKA Infection, run by Hospices Civils de Lyon at 1 site in 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 1 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 18 Oct 2016. 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 France. 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?
functional results (time frame: at two years follow up). The study lists 2 primary outcomes in all. 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 18 Oct 2016; AzTrials last refreshed its copy on 29 Oct 2026.