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