Knee ProsthesisMOTiVENCT05387694
Study of the Prognostic Value of the Coagulolytic Balance Dependent on Circulating Microvesicles in the Occurrence of Thrombotic Events After Total Knee Replacement in Orthopedic Surgery.
A study testing Thrombotic risk assessment in people with Knee Prosthesis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
This is a prospective multicenter cohort study to evaluate the prognostic value of new biological markers in predicting thrombotic events after orthopedic surgery. According to the inclusion and non-inclusion criteria below, the study will include 387 major subjects who will undergo first-line total knee replacement… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Knee Prosthesis
- What is being tested?
- Thrombotic risk assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject, male or female, aged 18 to 85 years (upper age limit classically used in the literature of PTG79-81)
- First-line TKP (knee native to any prosthesis) performed to treat primary or secondary osteoarthritis.
- In case of contralateral PTG, a delay of 12 months between the 2 prostheses will be respected according to the habits of the inclusion centers.
- ASA score <4 (American Society of Anesthesiologists)
- No contraindication to prophylactic treatment with low molecular weight heparin (LMWH)
- Subject not taking anticoagulant or antiaggregant therapy at therapeutic dose
- Subject who has signed the informed consent form
- Subject affiliated to the social security system
Who cannot join
- Subjects with a history of sepsis, tumor or trauma in the considered joint
- Subject with sepsis or acute infection
- Immunocompromised subject (HIV, transplant, chemotherapy, leukemia, glucocorticoids >3 months)
- Subjects with severe respiratory, circulatory or cardiac pathologies involving anticoagulant treatment likely to influence the coagulolytic balance.
- Subject with severe renal insufficiency (creatinine clearance < 30ml/min)
- Subject refusing to participate in the study or not signing the informed consent or unable to adhere to the study procedures
- Subjects who are minors, pregnant or breastfeeding, not affiliated with the social security system, or deprived of liberty
- Subject already included in an interventional trial (which may alter the results of that study)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Assistance Publique Hopitaux de Marseille
Marseille, Bouches Du Rhône, 13354
Alexandra GIULIANI, alexandra.giuliani@ap-hm.fr
About this study
This is a prospective multicenter cohort study to evaluate the prognostic value of new biological markers in predicting thrombotic events after orthopedic surgery. According to the inclusion and non-inclusion criteria below, the study will include 387 major subjects who will undergo first-line total knee replacement and will receive the same standard prophylactic treatment: anticoagulation with Lovenox® (enoxaparin) 4000 IU/d subcutaneously 6 to 8 hours postoperatively and then daily for 15 days in combination with compression stockings.
Read the detailed description
Recruitment and follow-up of patients will be carried out in 3 hospitals by the respective orthopedic teams. Three hundred and eighty-seven patients will be included in the study, over a period of 36 months: 200 in Marseille, 100 in Nice and 87 in Nîmes.
The objective of the study was to evaluate the prognostic capacities of the coagulolytic balance of MVs measured after surgery at D0 in the occurrence of a symptomatic or asymptomatic venous thromboembolic event revealed by echodoppler at 1 month after total knee replacement surgery.
The management of the subjects is unchanged from the current recommendations and will be homogeneous between the three inclusion centers. Patients will be hospitalized for 5 days and will receive the usual prophylactic anticoagulant treatment with Lovenox® (enoxaparin sodium; LMWH) 4000 IU/d subcutaneously 6 to 8 hours postoperatively and then daily for 15 days in combination with compression stockings, which corresponds to the management of a PTG according to current recommendations.
- Conditions
- Knee Prosthesis
- Being tested
- Thrombotic risk assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombotic risk assessmentOther
Collection of symptomatic thrombotic events occurring during the 5 days of hospitalization and then by telephone interview at M1 +/- 3 days. Complete echodoppler (proximal and distal) performed at M1 to highlight asymptomatic thrombotic events.
| Study group | Role | What they receive |
|---|---|---|
| Knee prosthesis group | Experimental | Not described Receives: Other: Thrombotic risk assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Receiver Operating Characteristic curve
To assess the prognostic value of the microvesicle-dependent coagulolytic balance measured after D0 surgery (pre-administration of prophylactic treatment) in the occurrence of a post-total knee replacement thrombotic event (distal or proximal).
Measured: After surgery at Day 0
Secondary outcomes (4)
Best prognostic threshold of MV coagulolytic balance measured
Maximize sensitivity and specificity (Youden's method), and intrinsic and extrinsic performances associated with the threshold: sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, positive predictive value, negative predictive value, with their 95% confidence intervals.
Measured: After surgery at Day 0
Estimation of the area under the ROC curve with its 95% confidence interval - The procoagulant activity of MV is dependent on FT
To assess the overall prognostic value of FT-dependent MV procoagulant activity at D0 (pre- and post-surgery) and D3, for the occurrence of a symptomatic or asymptomatic thrombotic event at 1 month post-PTG, the best prognostic threshold, and the intrinsic and extrinsic performance associated with the determined threshold, together with their 95% confidence intervals
Measured: Day 0, Day 3 and 1 month post-PTG
Estimation of the area under the ROC curve with its 95% confidence interval - Fibrinolytic activity of MV
Allows assessment of the overall prognostic value of MV fibrinolytic activity at D0 (pre- and post-surgery) and D3, for the occurrence of a symptomatic or asymptomatic thrombotic event at 1 month post-PTG, best prognostic threshold, and intrinsic and extrinsic performance associated with the determined threshold, together with their 95% confidence interval.
Measured: Day 0, Day 3 and 1 month post-PTG
Estimation of the area under the ROC curve with its 95% confidence interval - Coagulolytic balance of MV
Allows assessment of the prognostic value of the coagulolytic balance of MVs at D0 (before and after surgery) and D3, for the occurrence of a symptomatic thrombotic event (pulmonary embolism or DVT) at 1 month post-PTG, the best prognostic threshold, and the intrinsic and extrinsic performances associated with the determined threshold, together with their 95% confidence interval
Measured: Day 0, Day 3 and 1 month post-PTG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study startJun 2023 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ProsthesisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 387 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, Assistance Publique Hopitaux De MarseilleMatthieu OLLIVIER, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387694
- Sponsor's protocol ID
- 2022-A00582-41
- Acronym
- MOTiVE
- Status last verified
- Apr 2023
- First submitted
- 19 May 2022
- Last updated
- 21 Apr 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 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prognostic Value of the Coagulolytic Balance Dependent on Circulating Microvesicles in the Occurrence of Thrombotic Events After Total Knee Replacement in Orthopedic Surgery.
- ClinicalTrials.gov ID
- NCT05387694
- Acronym / sponsor ID
- MOTiVE / 2022-A00582-41
- Conditions
- Knee Prosthesis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 387 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 May 2022 (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.
This is a prospective multicenter cohort study to evaluate the prognostic value of new biological markers in predicting thrombotic events after orthopedic surgery. According to the inclusion and non-inclusion criteria below, the study will include 387 major subjects who will undergo first-line total knee replacement and will receive the same standard prophylactic treatment: anticoagulation with Lovenox® (enoxaparin) 4000 IU/d subcutaneously 6 to 8 hours postoperatively and then daily for 15 days in combination with compression stockings.
Detailed description
Recruitment and follow-up of patients will be carried out in 3 hospitals by the respective orthopedic teams. Three hundred and eighty-seven patients will be included in the study, over a period of 36 months: 200 in Marseille, 100 in Nice and 87 in Nîmes.
The objective of the study was to evaluate the prognostic capacities of the coagulolytic balance of MVs measured after surgery at D0 in the occurrence of a symptomatic or asymptomatic venous thromboembolic event revealed by echodoppler at 1 month after total knee replacement surgery.
The management of the subjects is unchanged from the current recommendations and will be homogeneous between the three inclusion centers. Patients will be hospitalized for 5 days and will receive the usual prophylactic anticoagulant treatment with Lovenox® (enoxaparin sodium; LMWH) 4000 IU/d subcutaneously 6 to 8 hours postoperatively and then daily for 15 days in combination with compression stockings, which corresponds to the management of a PTG according to current recommendations.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee prosthesis group | Experimental | Other: Thrombotic risk assessment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject, male or female, aged 18 to 85 years (upper age limit classically used in the literature of PTG79-81)
- First-line TKP (knee native to any prosthesis) performed to treat primary or secondary osteoarthritis.
- In case of contralateral PTG, a delay of 12 months between the 2 prostheses will be respected according to the habits of the inclusion centers.
- ASA score <4 (American Society of Anesthesiologists)
- No contraindication to prophylactic treatment with low molecular weight heparin (LMWH)
Key exclusion criteria (8 listed)
- Subjects with a history of sepsis, tumor or trauma in the considered joint
- Subject with sepsis or acute infection
- Immunocompromised subject (HIV, transplant, chemotherapy, leukemia, glucocorticoids >3 months)
- Subjects with severe respiratory, circulatory or cardiac pathologies involving anticoagulant treatment likely to influence the coagulolytic balance.
- Subject with severe renal insufficiency (creatinine clearance < 30ml/min)
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 |
|---|---|---|
| Thrombotic risk assessmentCollection of symptomatic thrombotic events occurring during the 5 days of hospitalization and then by telephone interview at M1 +/- 3 days. Complete echodoppler (proximal and distal) performed at M1 to highlight asymptomatic thrombotic events. | Other | Knee prosthesis group |
Primary outcome
Area under the Receiver Operating Characteristic curve
Time frame: After surgery at Day 0
To assess the prognostic value of the microvesicle-dependent coagulolytic balance measured after D0 surgery (pre-administration of prophylactic treatment) in the occurrence of a post-total knee replacement thrombotic event (distal or proximal).
4 secondary outcomes
Best prognostic threshold of MV coagulolytic balance measured
Time frame: After surgery at Day 0
Estimation of the area under the ROC curve with its 95% confidence interval - The procoagulant activity of MV is dependent on FT
Time frame: Day 0, Day 3 and 1 month post-PTG
Estimation of the area under the ROC curve with its 95% confidence interval - Fibrinolytic activity of MV
Time frame: Day 0, Day 3 and 1 month post-PTG
Estimation of the area under the ROC curve with its 95% confidence interval - Coagulolytic balance of MV
Time frame: Day 0, Day 3 and 1 month post-PTG
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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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.
François CREMIEUX study director
Assistance Publique Hopitaux De Marseille
Matthieu OLLIVIER principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrombotic risk assessment in people with Knee Prosthesis, run by Assistance Publique Hopitaux De Marseille 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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 21 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthieu OLLIVIER (04.91.74.50.12 ext. +33, matthieu.ollivier@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the Receiver Operating Characteristic curve (time frame: After surgery at Day 0). 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 21 Apr 2023.