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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 :
Our hypothesis is that the method of femoral fixation in THA influences bleeding and blood loss, with a benefit for cemented fixations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cemented fixation | Experimental | Total hip replacement with cemented fixation |
|
| Non-cemented fixation | Active Comparator | Total hip replacement with non-cemented fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total hip replacement with cemented fixation | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marion Mandon, PhD | Contact | +336 78 27 76 72 | drc@vivalto-sante.com |
| Name | Affiliation | Role |
|---|---|---|
| Laurent Abane, MD | Clinique du Pré | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Jeanne d'Arc | Gien | 45500 | France |
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|
| Total hip replacement with non-cemented fixation | Procedure | 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. |
|
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 |
| Clinique du Pré | Le Mans | 72000 | France |
|
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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