CClinicalTrials.gg
Not yet recruitingNCT07492212FEMFIXUpdated Mar 25, 2026

Comparison of Blood Loss Between Cemented and Uncemented Femoral Stems in Anterior Total Hip Arthroplasty

An interventional study of Total hip replacement with cemented fixation and Total hip replacement with non-cemented fixation in Total Hip Arthroplasty (THA), sponsored by Clinique du Pré. Not yet recruiting at 2 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-25.

Sponsored by Clinique du Pré · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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...
  • 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.

02

Conditions studied

  • Total Hip Arthroplasty (THA)

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Keywords

  • hip arthroplasty
  • implant
  • blood loss
03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's planned enrollment of 86 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

This is the only study on the registry with Clinique du Pré as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patient needed a total hip arthroplasty

Exclusion criteria

Exclusion Criteria:

  • Previous surgery on the affected hip
  • Preoperative anemia
  • Femoral neck fracture
  • Patient with a contraindication to tranexamic acid
  • Pregnant or breastfeeding patient
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
86 participants (estimated)

Study arms

  • Experimental
    Cemented fixation

    Total hip replacement with cemented fixation

    Procedure: Total hip replacement with cemented fixation

  • Active comparator
    Non-cemented fixation

    Total hip replacement with non-cemented fixation

    Procedure: Total hip replacement with non-cemented fixation

Interventions

  • ProcedureTotal hip replacement with cemented fixation

    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.

  • ProcedureTotal hip replacement with non-cemented fixation

    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.

06

What researchers measure

Primary outcomes

  1. Total blood loss

    Mercuriali formula : Estimated total blood volume × \[Preoperative hematocrit (Ht) - Ht on day 5\] + volume of red blood cells transfused

    Time frame: The day of surgery

Secondary outcomes

  1. 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.

    Time frame: between day 0 and day 5 after surgery

  2. 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.

    Time frame: Between day 0 and day 5 after surgery

  3. 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.

    Time frame: 2 months, 6 months and 12 months after surhery

  4. 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.

    Time frame: 2 months, 6 months and 12 months after surgery

  5. 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.

    Time frame: 2 months, 6 months and 12 months after surgery

07

Study locations

2 sites
  • Clinique Jeanne d'Arc
    Gien, 45500, France
  • Clinique du Pré
    Le Mans, 72000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07492212
Lead sponsor
Clinique du Pré
Responsible party
Sponsor
First posted
Mar 25, 2026
Start date
Apr 15, 2026 (estimated)
Primary completion
Mar 31, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Mar 25, 2026

Study contacts

Marion Mandon, PhD
Contact
drc@vivalto-sante.com
+336 78 27 76 72
Laurent Abane, MD
principal investigator · Clinique du Pré

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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