Total Hip Arthroplasty (THA)FEMFIXNCT07492212
Comparison of Blood Loss Between Cemented and Uncemented Femoral Stems in Anterior Total Hip Arthroplasty
A study testing Total hip replacement with cemented fixation and Total hip replacement with non-cemented fixation in people with Total Hip Arthroplasty (THA), run by Clinique du Pré at 2 sites in France.
Trial summary
Total hip arthroplasty (THA) yields excellent results. To perform the procedure, the surgeon must make certain decisions, including the choice of fixation method for the femoral implant. This surgery, considered to carry a risk of bleeding, therefore exposes the patient : to complications: heart attacks, strokes... Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Hip Arthroplasty (THA)
- What is being tested?
- Total hip replacement with cemented fixation and Total hip replacement with non-cemented fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Apr 2026to 30 Jun 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient needed a total hip arthroplasty
Who cannot join
- Previous surgery on the affected hip
- Preoperative anemia
- Femoral neck fracture
- Patient with a contraindication to tranexamic acid
- Pregnant or breastfeeding patient
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Clinique Jeanne d'Arc
Gien, 45500
Marion Mandon, PhD, +336 78 27 76 72, drc@vivalto-sante.com
Clinique du Pré
Le Mans, 72000
Marion Mandon, PhD, +336 78 27 76 72, drc@vivalto-sante.com
About this study
Official title: Comparison of Blood Loss Between Cemented and Uncemented Femoral Stems in Anterior Total Hip Arthroplasty - A Prospective, Randomized, Multicenter Study
Total hip arthroplasty (THA) yields excellent results. To perform the procedure, the surgeon must make certain decisions, including the choice of fixation method for the femoral implant.
This surgery, considered to carry a risk of bleeding, therefore exposes the patient :
Read more
- to complications: heart attacks, strokes...
- to mortality
- to transfusion: specific risks, cost, length of hospital stay
- to anemia: fatigue, longer recovery time The influence of the femoral fixation method on bleeding and blood loss is often debated, but the literature on the subject is very limited.
Our hypothesis is that the method of femoral fixation in THA influences bleeding and blood loss, with a benefit for cemented fixations.
- Conditions
- Total Hip Arthroplasty (THA)
- Being tested
- Total hip replacement with cemented fixation, Total hip replacement with non-cemented fixation
- Keywords
- hip arthroplasty, implant, blood loss
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip replacement with cemented fixationProcedure or surgery
Total hip arthroplasty performed using cemented fixation of the prosthetic components. A femoral stem and acetabular cup are implanted and secured to the bone using polymethylmethacrylate (PMMA) bone cement. This technique provides immediate mechanical stability and is commonly used in patients with reduced bone quality, such as elderly individuals or those with osteoporosis. The procedure aims to relieve pain, restore joint function, and allow early weight-bearing following surgery.
Total hip replacement with non-cemented fixationProcedure or surgery
Total hip arthroplasty performed using uncemented (press-fit) fixation of the prosthetic components. The femoral stem and acetabular cup are implanted without cement and rely on biological fixation through bone ingrowth into the implant surface. Initial stability is achieved by press-fit insertion, with long-term fixation depending on osseointegration. This technique is often preferred in younger or more active patients with good bone quality. The procedure aims to relieve pain, restore mobility, and ensure durable implant fixation.
| Study group | Role | What they receive |
|---|---|---|
| Cemented fixation | Experimental | Total hip replacement with cemented fixation Receives: Procedure: Total hip replacement with cemented fixation |
| Non-cemented fixation | Active comparator | Total hip replacement with non-cemented fixation Receives: Procedure: Total hip replacement with non-cemented fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total blood loss
Mercuriali formula : Estimated total blood volume × [Preoperative hematocrit (Ht) - Ht on day 5] + volume of red blood cells transfused
Measured: The day of surgery
Secondary outcomes (5)
occurrence of a blood transfusion
Occurrence of perioperative blood transfusion, defined as the administration of any allogeneic or autologous red blood cell units during surgery or within the postoperative hospitalization period.
Measured: between day 0 and day 5 after surgery
Surgical revision for hematoma
Occurrence of surgical reintervention due to postoperative hematoma at the operated hip site. This includes any return to the operating room for evacuation of a hematoma within the defined postoperative follow-up period.
Measured: Between day 0 and day 5 after surgery
Clinical score Postel Merle d'Aubigné
Assessment of hip function using the Postel-Merle d'Aubigné (PMA) score, which evaluates pain, mobility, and walking ability. Each domain is scored from 0 to 6, with a total score ranging from 0 to 18, where higher scores indicate better function.
Measured: 2 months, 6 months and 12 months after surhery
Harris Hip score
Assessment of hip function using the Harris Hip Score (HHS), a clinician-based outcome measure evaluating pain, function, absence of deformity, and range of motion. The total score ranges from 0 to 100, with higher scores indicating better hip function.
Measured: 2 months, 6 months and 12 months after surgery
Oxford score
a validated questionnaire consisting of 12 items related to pain and daily activities. Each item is scored from 0 to 4, with a total score ranging from 0 to 48, where higher scores indicate better outcomes.
Measured: 2 months, 6 months and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Arthroplasty (THA)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique du Pré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Abane, MD, Principal investigator, Clinique du Pré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492212
- Sponsor's protocol ID
- 2025-61-PRM
- Acronym
- FEMFIX
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 25 Mar 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blood Loss Between Cemented and Uncemented Femoral Stems in Anterior Total Hip Arthroplasty - A Prospective, Randomized, Multicenter Study
- ClinicalTrials.gov ID
- NCT07492212
- Acronym / sponsor ID
- FEMFIX / 2025-61-PRM
- Conditions
- Total Hip Arthroplasty (THA)
- Keywords
- hip arthroplasty, implant, blood loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Clinique du PréUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 25 Mar 2026 (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.
Total hip arthroplasty (THA) yields excellent results. To perform the procedure, the surgeon must make certain decisions, including the choice of fixation method for the femoral implant.
This surgery, considered to carry a risk of bleeding, therefore exposes the patient :
- to complications: heart attacks, strokes...
- to mortality
- to transfusion: specific risks, cost, length of hospital stay
- to anemia: fatigue, longer recovery time The influence of the femoral fixation method on bleeding and blood loss is often debated, but the literature on the subject is very limited.
Our hypothesis is that the method of femoral fixation in THA influences bleeding and blood loss, with a benefit for cemented fixations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cemented fixation | Experimental | Procedure: Total hip replacement with cemented fixationTotal hip replacement with cemented fixation |
| Non-cemented fixation | Active comparator | Procedure: Total hip replacement with non-cemented fixationTotal hip replacement with non-cemented fixation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient needed a total hip arthroplasty
Key exclusion criteria (5 listed)
- Previous surgery on the affected hip
- Preoperative anemia
- Femoral neck fracture
- Patient with a contraindication to tranexamic acid
- Pregnant or breastfeeding patient
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 |
|---|---|---|
| Total hip replacement with cemented fixationTotal hip arthroplasty performed using cemented fixation of the prosthetic components. A femoral stem and acetabular cup are implanted and secured to the bone using polymethylmethacrylate (PMMA) bone cement. This technique provides immediate mechanical stability and is commonly used in patients with reduced bone quality, such as elderly individuals or those with osteoporosis. The procedure aims to relieve pain, restore joint function, and allow early weight-bearing following surgery. | Procedure or surgery | Cemented fixation |
| Total hip replacement with non-cemented fixationTotal hip arthroplasty performed using uncemented (press-fit) fixation of the prosthetic components. The femoral stem and acetabular cup are implanted without cement and rely on biological fixation through bone ingrowth into the implant surface. Initial stability is achieved by press-fit insertion, with long-term fixation depending on osseointegration. This technique is often preferred in younger or more active patients with good bone quality. The procedure aims to relieve pain, restore mobility, and ensure durable implant fixation. | Procedure or surgery | Non-cemented fixation |
Primary outcome
Total blood loss
Time frame: The day of surgery
Mercuriali formula : Estimated total blood volume × [Preoperative hematocrit (Ht) - Ht on day 5] + volume of red blood cells transfused
5 secondary outcomes
occurrence of a blood transfusion
Time frame: between day 0 and day 5 after surgery
Surgical revision for hematoma
Time frame: Between day 0 and day 5 after surgery
Clinical score Postel Merle d'Aubigné
Time frame: 2 months, 6 months and 12 months after surhery
Harris Hip score
Time frame: 2 months, 6 months and 12 months after surgery
Oxford score
Time frame: 2 months, 6 months and 12 months after surgery
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 25 Mar 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.
Laurent Abane, MD principal investigator
Clinique du Pré
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total hip replacement with cemented fixation and Total hip replacement with non-cemented fixation in people with Total Hip Arthroplasty (THA), run by Clinique du Pré at 2 sites 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 5 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 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Marion Mandon, PhD (+336 78 27 76 72, drc@vivalto-sante.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total blood loss (time frame: The day of surgery). 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 25 Mar 2026.