Hip or Knee ReplacementHKPNCT06183606
Interest of High-dose Gentamicin Cement Associated With Clindamycin in Changes of Hip and Knee Prostheses
An observational study of Hip or Knee Replacement, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
A hip or knee prosthesis can be cemented or not. The team of orthopedic surgeons from the CCOM (Centre de Chirurgie Orthopédique et de la Main) has been cementing all hip and knee prosthesis poses for many years using gentamycin cement as recommended by the French Society of Orthopedic Surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip or Knee Replacement
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2019to Dec 2023
- 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: Adult subject (≥18 years old) operated on at the HUS between 01/02/2017 and 31/01/2019, for replacement of hip and knee prostheses.
Who may be able to join
- Adult subject (≥18 years old)
- Patient operated on at the HUS between 01/02/2017 and 31/01/2019, for replacement of hip and knee prostheses
- Patient having given their consent for the reuse of their data for the purposes of this research
Who cannot join
- Patient who expressed their opposition to participating in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France
Strasbourg, 67091
Jeannot GAUDIAS, MD, 33 3 68 76 50 62, jeannot.gaudias@chru-strasbourg.fr
Jeannot GAUDIAS, MD
About this study
Official title: Local Antibiotic Prophylaxis With Antibiotic Cement: Interest of High-dose Gentamicin Cement Associated With Clindamycin in Changes of Hip and Knee Prostheses
A hip or knee prosthesis can be cemented or not. The team of orthopedic surgeons from the CCOM (Centre de Chirurgie Orthopédique et de la Main) has been cementing all hip and knee prosthesis poses for many years using gentamycin cement as recommended by the French Society of Orthopedic Surgery. and trauma (SOFCOT) (1). Data obtained from the Norwegian Register of Hip Prostheses show that the best survival curve for these prostheses is found for prostheses cemented with gentamycin cement (all causes combined). Independently of the risk of aseptic loosening, infection on the prosthesis is the second complication of arthroplasty. The defense mechanism against pathogens in contact with an implant is the formation of a biofilm. Biofilm bacteria are metabolically inactive and characterized by stationary growth. Due to their slower replication, bacteria in biofilm are up to 1000 times more resistant to antibiotics. Therefore, the optimization of local antibiotic prophylaxis is essential.
- Conditions
- Hip or Knee Replacement
- Keywords
- Hip Replacement, knee Replacement, Local antibiotic prophylaxis, Antibiotic cement, Gentamicin cement, Clindamycin
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of surgical site infections (SSI) after changes of hip and knee prostheses
Retrospective description of the benefit of high-dose gentamicin cement combined with clindamycin in hip and knee prosthesis changes
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start14 Jun 2019
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip or Knee ReplacementStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183606
- Sponsor's protocol ID
- 7411
- Acronym
- HKP
- Status last verified
- Dec 2023
- First submitted
- 26 Oct 2022
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Antibiotic Prophylaxis With Antibiotic Cement: Interest of High-dose Gentamicin Cement Associated With Clindamycin in Changes of Hip and Knee Prostheses
- ClinicalTrials.gov ID
- NCT06183606
- Acronym / sponsor ID
- HKP / 7411
- Conditions
- Hip or Knee Replacement
- Keywords
- Hip Replacement, knee Replacement, Local antibiotic prophylaxis, Antibiotic cement, Gentamicin cement, Clindamycin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 Dec 2023 (actual)
- 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.
A hip or knee prosthesis can be cemented or not. The team of orthopedic surgeons from the CCOM (Centre de Chirurgie Orthopédique et de la Main) has been cementing all hip and knee prosthesis poses for many years using gentamycin cement as recommended by the French Society of Orthopedic Surgery. and trauma (SOFCOT) (1). Data obtained from the Norwegian Register of Hip Prostheses show that the best survival curve for these prostheses is found for prostheses cemented with gentamycin cement (all causes combined). Independently of the risk of aseptic loosening, infection on the prosthesis is the second complication of arthroplasty. The defense mechanism against pathogens in contact with an implant is the formation of a biofilm. Biofilm bacteria are metabolically inactive and characterized by stationary growth. Due to their slower replication, bacteria in biofilm are up to 1000 times more resistant to antibiotics. Therefore, the optimization of local antibiotic prophylaxis is essential.
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
- Adult subject (≥18 years old) operated on at the HUS between 01/02/2017 and 31/01/2019, for replacement of hip and knee prostheses.
Key inclusion criteria (3 listed)
- Adult subject (≥18 years old)
- Patient operated on at the HUS between 01/02/2017 and 31/01/2019, for replacement of hip and knee prostheses
- Patient having given their consent for the reuse of their data for the purposes of this research
Key exclusion criteria (1 listed)
- Patient who expressed their opposition to participating in the study
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
Retrospective study of surgical site infections (SSI) after changes of hip and knee prostheses
Time frame: Through study completion, an average of 3 months
Retrospective description of the benefit of high-dose gentamicin cement combined with clindamycin in hip and knee prosthesis changes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
Related trials for Hip or Knee Replacement
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
RecruitingObservational study
Tau Pathology in the Brain After Hip or Knee Replacement Surgery
Postoperative Cognitive Dysfunction, Alzheimer Disease
Recruiting
Virtual Reality Therapy to Improve Arthroplasty Outcomes
Surgical, Anxiety
Not yet recruiting
The Impact of Regional Motor-sparing Blocks on Early Rehabilitation Following Primary Hip or Knee Arthroplasty
Total Hip Arthroplasty (THA) or Total Knee Arthroplasty (TKA), Preoperative Adductor Canal Block (ACB)
RecruitingPhase 4
inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT
Venous Thromboembolism, Venous Thromboses
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.
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 Hip or Knee Replacement, run by University Hospital, Strasbourg, France 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 3 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 27 Dec 2023. 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?
Contact Jeannot GAUDIAS, MD (33 3 68 76 50 62, jeannot.gaudias@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study of surgical site infections (SSI) after changes of hip and knee prostheses (time frame: Through study completion, an average of 3 months). 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 27 Dec 2023.