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Clinical Trial NCT07492212 (FEMFIX) for Total Hip Arthroplasty (THA) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Comparison of Blood Loss Between Cemented and Uncemented Femoral Stems in Anterior Total Hip Arthroplasty (FEMFIX) 86

Not yet recruiting
Clinical Trial NCT07492212 (FEMFIX) is an interventional study for Total Hip Arthroplasty (THA) and is currently not yet recruiting. Enrollment is planned to begin on 15 April 2026 and continue until the study accrues 86 participants. Led by Clinique du Pré, this study is expected to complete by 30 June 2028. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief 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...
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Official Title

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

Conditions
Total Hip Arthroplasty (THA)
Other Study IDs
  • FEMFIX
  • 2025-61-PRM
NCT ID Number
NCT07492212
Start Date (Actual)
2026-04-15
Last Update Posted
2026-03-25
Completion Date (Estimated)
2028-06-30
Enrollment (Estimated)
86
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
hip arthroplasty
implant
blood loss
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalCemented fixation
Total hip replacement with cemented fixation
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, resto...Show More
Active ComparatorNon-cemented fixation
Total hip replacement with non-cemented fixation
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 patie...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • patient needed a total hip arthroplasty

  • Previous surgery on the affected hip
  • Preoperative anemia
  • Femoral neck fracture
  • Patient with a contraindication to tranexamic acid
  • Pregnant or breastfeeding patient
Clinique du Pré logoClinique du Pré
Study Central Contact
Contact: Marion Mandon, PhD, +336 78 27 76 72, [email protected]
2 Study Locations in 1 Countries
Clinique Jeanne d'Arc, Gien, 45500, France
Marion Mandon, PhD, Contact, +336 78 27 76 72, [email protected]
Clinique du Pré, Le Mans, 72000, France
Marion Mandon, PhD, Contact, +336 78 27 76 72, [email protected]