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

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 :

• 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 Overview

• Status: Not yet recruiting
• Conditions: Total Hip Arthroplasty (THA)
• Intervention / Treatment: Procedure: Total hip replacement with cemented fixation; Procedure: Total hip replacement with non-cemented fixation

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marion Mandon, PhD; Phone Number: +336 78 27 76 72; Email: drc@vivalto-sante.com

Study Locations

• France
  • Gien, France, 45500
    • Clinique Jeanne d'Arc
    • Contact: Marion Mandon, PhD; Phone Number: +336 78 27 76 72; Email: drc@vivalto-sante.com
  • Le Mans, France, 72000
    • Clinique Du Pre
    • Contact: Marion Mandon, PhD; Phone Number: +336 78 27 76 72; Email: drc@vivalto-sante.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cemented fixation; Total hip replacement with cemented fixation	Procedure: Total 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.
Active Comparator: Non-cemented fixation; Total hip replacement with non-cemented fixation	Procedure: Total 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total blood loss	Mercuriali formula : Estimated total blood volume × [Preoperative hematocrit (Ht) - Ht on day 5] + volume of red blood cells transfused	The day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	2 months, 6 months and 12 months after surgery

Collaborators and Investigators

• Sponsor: Clinique du Pré
• Investigators: Principal Investigator: Laurent Abane, MD, Clinique Du Pre

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: blood loss; hip arthroplasty; implant
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage; Surgical Procedures, Operative; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation; Arthroplasty, Replacement, Hip
• Other Study ID Numbers: 2025-61-PRM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No