Arthroplasty ComplicationsNCT06563531
Are Elastic Restraints Still Necessary in Improved Rehabilitation Programs After Hip and Knee Prosthetic Surgery?
A study testing Pharmacological thromboprophylaxis and elastic compression and Pharmacological thromboprophylaxis without elastic compression in people with Arthroplasty Complications, run by Clinique Pasteur Lanroze at 1 site in France.
Trial summary
Venous thrombosis and pulmonary embolism are considered serious and potentially preventable complications of hip and knee replacement surgery. The risks of thrombosis must be weighed against the risks associated with preventive measures, both mechanical and pharmacological. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty Complications
- What is being tested?
- Pharmacological thromboprophylaxis and elastic compression and Pharmacological thromboprophylaxis without elastic compression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,274 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2024to 15 Jul 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first line and non-traumatic total hip or knee arthroplasty
- Patient included in an Enhanced Rehabilitation after Surgery (ERS) or "fast-track" protocol, or scheduled as an outpatient.
Who cannot join
- Patient requiring long-term anticoagulation for pre-existing co-morbidity
- Patients with coagulation disorders (hypercoagulability)
- Patient undergoing thrombogenic pharmacological treatment
- History of obliterative arteriopathy of the lower limbs
- Arterial disease
- Obesity
Show all 21Show fewer
- Heart failure
- Chronic bronchopneumopathy
- Lymphedema
- Chronic inflammatory disease
- Permanent wearing of elastic restraints
- Proximal or distal arterial bypass surgery
- Creatinine clearance < 15 ml/min
- Inability to give consent
- Revision surgery for hip or knee prosthesis
- Metastatic cancer
- Life expectancy less than 3 months
- Allergy to socks or compression stockings
- Patients presenting one or more exclusion criteria for the fast-track protocol (severe or poorly-balanced associated conditions such as diabetes or immunodepression, inability to contact the doctor or hospital department if necessary, pre-operative ASA score greater than or equal to 4).
- Adults under guardianship or curatorship
- Vulnerable persons in accordance with article L1121-6 of the CSP (French Public Health Code)
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, 1 recruiting
- Recruiting
Clinique Pasteur Lanroze
Brest, 29000
Anthony Monnier, +33 2 98 31 33 51, amonnier@chp-brest.bzh
About this study
Venous thrombosis and pulmonary embolism are considered serious and potentially preventable complications of hip and knee replacement surgery. The risks of thrombosis must be weighed against the risks associated with preventive measures, both mechanical and pharmacological. Modern medicine is now questioning the use of elastic restraints in surgery. Several studies have investigated the benefits of using restraints to prevent thromboembolic events. These studies have shown no additional benefit from the use of compression stockings in thromboembolism prevention. To the best of our knowledge, no orthopedic study has investigated the non-inferiority of pharmacological treatment compared with elastic compression devices, specifically in knee and hip surgery. The aim of this multicenter, prospective, randomized study is to investigate whether pharmacological prophylaxis alone is non-inferior to pharmacological and mechanical prophylaxis (using restraints) of peripheral venous thrombosis or pulmonary embolism up to 90 days after prosthetic surgery.
- Conditions
- Arthroplasty Complications
- Being tested
- Pharmacological thromboprophylaxis and elastic compression, Pharmacological thromboprophylaxis without elastic compression
- Keywords
- hip replacement surgery, knee replacement surgery, thromboprophylaxis, elastic compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacological thromboprophylaxis and elastic compressionProcedure or surgery
Patients benefit from thromboembolism prevention through pharmacological thromboprophylaxis and elastic restraint after total hip or knee arthroplasty.
Pharmacological thromboprophylaxis without elastic compressionProcedure or surgery
Patients benefit from thromboembolism prevention through pharmacological thromboprophylaxis only after total hip or knee arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| Elastic compression | Active comparator | Not described Receives: Procedure: Pharmacological thromboprophylaxis and elastic compression |
| No elastic compression | Experimental | Not described Receives: Procedure: Pharmacological thromboprophylaxis without elastic compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of venous thromboembolic events
Evaluation of venous thromboembolic events (symptomatic deep vein thrombosis, fatal or non-fatal pulmonary embolism).
Measured: day 1 ; day 21 ; day 90
Secondary outcomes (1)
Quality of life evaluation
Quality of life will be evaluated by EQ-5D-5L questionnaire : 5 questions with a Likert scale from 0 (no symptoms) to 4 (extreme symptoms), with a final result from 0 to 20.
Measured: day 1 ; day 21 ; day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start15 Nov 2024
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ComplicationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Pasteur Lanroze
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563531
- Sponsor's protocol ID
- 2022-04-CPL
- Status last verified
- Mar 2026
- First submitted
- 19 Aug 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Elastic Restraints Still Necessary in Improved Rehabilitation Programs After Hip and Knee Prosthetic Surgery?
- ClinicalTrials.gov ID
- NCT06563531
- Acronym / sponsor ID
- 2022-04-CPL
- Conditions
- Arthroplasty Complications
- Keywords
- hip replacement surgery, knee replacement surgery, thromboprophylaxis, elastic compression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,274 participants (estimated)
- Lead sponsor
- Clinique Pasteur LanrozeUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 21 Aug 2024 (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.
Venous thrombosis and pulmonary embolism are considered serious and potentially preventable complications of hip and knee replacement surgery. The risks of thrombosis must be weighed against the risks associated with preventive measures, both mechanical and pharmacological. Modern medicine is now questioning the use of elastic restraints in surgery. Several studies have investigated the benefits of using restraints to prevent thromboembolic events. These studies have shown no additional benefit from the use of compression stockings in thromboembolism prevention. To the best of our knowledge, no orthopedic study has investigated the non-inferiority of pharmacological treatment compared with elastic compression devices, specifically in knee and hip surgery. The aim of this multicenter, prospective, randomized study is to investigate whether pharmacological prophylaxis alone is non-inferior to pharmacological and mechanical prophylaxis (using restraints) of peripheral venous thrombosis or pulmonary embolism up to 90 days after prosthetic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elastic compression | Active comparator | Procedure: Pharmacological thromboprophylaxis and elastic compression |
| No elastic compression | Experimental | Procedure: Pharmacological thromboprophylaxis without elastic compression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- first line and non-traumatic total hip or knee arthroplasty
- Patient included in an Enhanced Rehabilitation after Surgery (ERS) or "fast-track" protocol, or scheduled as an outpatient.
Key exclusion criteria (21 listed)
- Patient requiring long-term anticoagulation for pre-existing co-morbidity
- Patients with coagulation disorders (hypercoagulability)
- Patient undergoing thrombogenic pharmacological treatment
- History of obliterative arteriopathy of the lower limbs
- Arterial disease
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 |
|---|---|---|
| Pharmacological thromboprophylaxis and elastic compressionPatients benefit from thromboembolism prevention through pharmacological thromboprophylaxis and elastic restraint after total hip or knee arthroplasty. | Procedure or surgery | Elastic compression |
| Pharmacological thromboprophylaxis without elastic compressionPatients benefit from thromboembolism prevention through pharmacological thromboprophylaxis only after total hip or knee arthroplasty. | Procedure or surgery | No elastic compression |
Primary outcome
incidence of venous thromboembolic events
Time frame: day 1 ; day 21 ; day 90
Evaluation of venous thromboembolic events (symptomatic deep vein thrombosis, fatal or non-fatal pulmonary embolism).
1 secondary outcome
Quality of life evaluation
Time frame: day 1 ; day 21 ; day 90
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 6 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacological thromboprophylaxis and elastic compression and Pharmacological thromboprophylaxis without elastic compression in people with Arthroplasty Complications, run by Clinique Pasteur Lanroze 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 2 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 6 Apr 2026. 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 Romain Gérard, MD (+33 2 98 28 98 26, dr.romaingerard@protonmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of venous thromboembolic events (time frame: day 1 ; day 21 ; day 90). 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 6 Apr 2026.