Total Hip Arthroplasty (THA)
Conditions
Keywords
hip arthroplasty, implant, blood loss
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, 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
PROCEDURETotal 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.
PROCEDURETotal 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.
Sponsors
Clinique du Pré
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total blood loss | The day of surgery | Mercuriali formula : Estimated total blood volume × \[Preoperative hematocrit (Ht) - Ht on day 5\] + volume of red blood cells transfused |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of a blood transfusion | 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. |
| Surgical revision for hematoma | 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. |
| Clinical score Postel Merle d'Aubigné | 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. |
| Harris Hip score | 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. |
| Oxford score | 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. |
Countries
France
Contacts
CONTACTMarion Mandon, PhD
PRINCIPAL_INVESTIGATORLaurent Abane, MD
Clinique du Pré
Outcome results
None listed