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Not yet recruiting NCT07492212

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

No phase Interventional Total Hip Arthroplasty (THA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Total hip replacement with cemented fixation, Total hip replacement with non-cemented fixation.
Who it may be relevant to
Registry conditions: Total Hip Arthroplasty (THA). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.
  • 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

Primary outcome measures

  • Total blood loss [Time frame: The day of surgery]
Secondary outcome measures (5)
  • occurrence of a blood transfusion [Time frame: between day 0 and day 5 after surgery]
  • Surgical revision for hematoma [Time frame: Between day 0 and day 5 after surgery]
  • Clinical score Postel Merle d'Aubigné [Time frame: 2 months, 6 months and 12 months after surhery]
  • Harris Hip score [Time frame: 2 months, 6 months and 12 months after surgery]
  • Oxford score [Time frame: 2 months, 6 months and 12 months after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 2 centers
  • Clinique Jeanne d'Arc — Gien
  • Clinique du Pré — Le Mans

Identifiers

NCT: NCT07492212 · 2025-61-PRM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗