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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorClinique du Pré

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patient needed a total hip arthroplasty

Disqualifiers

Previous surgery on the affected hip

Preoperative anemia

Femoral neck fracture

Patient with a contraindication to tranexamic acid

Trial design

Design model

Parallel

Treatments tested in this trial

  • Total hip replacement with cemented fixation

    Procedure/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 fixation

    Procedure/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.

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Cemented fixationExperimental treatment 1 intervention
Group B: Non-cemented fixationActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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