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NCT Number: NCT07492212

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

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.

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Key information

Conditions

Total Hip Arthroplasty (THA) Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Jeanne d'Arc, Gien, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient needed a total hip arthroplasty

Exclusion criteria

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

Treatment and study plan

Total hip replacement with cemented fixation

Procedure

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

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. occurrence of a blood transfusion

    Time frame: between day 0 and day 5 after surgery

    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.

  2. Surgical revision for hematoma

    Time frame: Between day 0 and day 5 after surgery

    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.

  3. Clinical score Postel Merle d'Aubigné

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

    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.

  4. Harris Hip score

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

    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.

  5. Oxford score

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marion Mandon, PhD

CONTACT

[email protected]

+336 78 27 76 72

Sponsors and collaborators

Lead sponsor

Clinique du Pré

Other

Registry information

Official study title

Comparison of Blood Loss Between Cemented and Uncemented Femoral Stems in Anterior Total Hip Arthroplasty - A Prospective, Randomized, Multicenter Study

Acronym: FEMFIX

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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