Hip and Knee Prosthesis ImplantationTBP-ASPIRNCT05128214
Aspirin Thromboprophylaxis After First-line Total Hip and Knee Replacement
An observational study of Hip and Knee Prosthesis Implantation, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Annually, more than 100,000 total hip prostheses (THA) and more than 100,000 total knee prostheses (TKA) are implanted for osteoarthritis in France, and these figures are set to increase significantly in the future as in all industrialized countries. . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip and Knee Prosthesis Implantation
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2021to 31 Dec 2021
- 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
- Adult, Older adult
Study population: Adult patient operated on for a first-line total hip or knee replacement by the principal investigator;
Who may be able to join
- Adult patient (≥ 18 years old);
- Patient operated on for a first-line total hip or knee replacement by the principal investigator;
- Patient not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.
Who cannot join
- Subject having expressed opposition to participating in the study
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Orthopédique Pédiatrique - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Jean-Yves JENNY, MD, PhD, 33 3 68 76 52 87, jean-yves.jenny@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Official title: Aspirin Thromboprophylaxis After First-line Total Hip and Knee Replacement. Comparison With Baseline Low Molecular Weight Heparin Prophylaxis
Annually, more than 100,000 total hip prostheses (THA) and more than 100,000 total knee prostheses (TKA) are implanted for osteoarthritis in France, and these figures are set to increase significantly in the future as in all industrialized countries. . Venous thrombosis is a potentially serious complication after PTH and PTG, justifying various prophylactic measures. In France, aggressive prophylaxis with low molecular weight heparin (LMWH) or direct oral anticoagulants (DOA) was until recently recommended, because this drug is considered to be the most effective, at the cost of a bleeding risk implicitly assumed but often poorly. evaluated. A recent publication suggests that the risk of bleeding is currently greater than the risk of a thromboembolic event.
More recently, foreign or international recommendations have broadened the range of these recommendations, notably by introducing aspirin as a possible prophylactic agent. While this molecule is potentially less effective than LMWHs or ADOs, it could decrease the risk of iatrogenic hemorrhage. The introduction of enhanced recovery procedures after surgery (RAAC) could decrease the risk of thrombosis without modifying the risk of bleeding, and thereby improve the cost-benefit ratio of aspirin, justifying its recent inclusion in the current French recommendations when The operated follows such a protocol.
- Conditions
- Hip and Knee Prosthesis Implantation
- Keywords
- Hip prosthesis implantation, Knee prosthesis implantation, Aspirin thromboprophylaxis, Heparin prophylaxis, Thromboembolic complications, Bleeding complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the postoperative thromboembolic complications after implantation of hip and knee prostheses
Measured: Files analysed retrospectively from July 01, 2016 to December 31, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start18 Jun 2021
- Primary completionDec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip and Knee Prosthesis ImplantationStudies 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
- Cohort
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128214
- Sponsor's protocol ID
- 8299
- Acronym
- TBP-ASPIR
- Status last verified
- Oct 2021
- First submitted
- 14 Oct 2021
- Last updated
- 30 Nov 2021
- 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 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin Thromboprophylaxis After First-line Total Hip and Knee Replacement. Comparison With Baseline Low Molecular Weight Heparin Prophylaxis
- ClinicalTrials.gov ID
- NCT05128214
- Acronym / sponsor ID
- TBP-ASPIR / 8299
- Conditions
- Hip and Knee Prosthesis Implantation
- Keywords
- Hip prosthesis implantation, Knee prosthesis implantation, Aspirin thromboprophylaxis, Heparin prophylaxis, Thromboembolic complications, Bleeding complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Nov 2021 (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.
Annually, more than 100,000 total hip prostheses (THA) and more than 100,000 total knee prostheses (TKA) are implanted for osteoarthritis in France, and these figures are set to increase significantly in the future as in all industrialized countries. . Venous thrombosis is a potentially serious complication after PTH and PTG, justifying various prophylactic measures. In France, aggressive prophylaxis with low molecular weight heparin (LMWH) or direct oral anticoagulants (DOA) was until recently recommended, because this drug is considered to be the most effective, at the cost of a bleeding risk implicitly assumed but often poorly. evaluated. A recent publication suggests that the risk of bleeding is currently greater than the risk of a thromboembolic event.
More recently, foreign or international recommendations have broadened the range of these recommendations, notably by introducing aspirin as a possible prophylactic agent. While this molecule is potentially less effective than LMWHs or ADOs, it could decrease the risk of iatrogenic hemorrhage. The introduction of enhanced recovery procedures after surgery (RAAC) could decrease the risk of thrombosis without modifying the risk of bleeding, and thereby improve the cost-benefit ratio of aspirin, justifying its recent inclusion in the current French recommendations when The operated follows such a protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient operated on for a first-line total hip or knee replacement by the principal investigator;
Key inclusion criteria (3 listed)
- Adult patient (≥ 18 years old);
- Patient operated on for a first-line total hip or knee replacement by the principal investigator;
- Patient not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.
Key exclusion criteria (1 listed)
- Subject having expressed 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
Study of the postoperative thromboembolic complications after implantation of hip and knee prostheses
Time frame: Files analysed retrospectively from July 01, 2016 to December 31, 2020 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
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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.
Saïd CHAYER, PhD, HDR contact
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 and Knee Prosthesis Implantation, 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 30 Nov 2021. 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 Jean-Yves JENNY, MD, PhD (33 3 68 76 52 87, 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?
Study of the postoperative thromboembolic complications after implantation of hip and knee prostheses (time frame: Files analysed retrospectively from July 01, 2016 to December 31, 2020 will be examined]). 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 30 Nov 2021.