NCT07492212

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
26mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Jun 2028

First Submitted

Initial submission to the registry

March 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 19, 2026

Last Update Submit

March 19, 2026

Conditions

Total Hip Arthroplasty (THA)

Keywords

hip arthroplastyimplantblood loss

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • occurrence of a blood transfusion

    between day 0 and day 5 after surgery

  • Surgical revision for hematoma

    Between day 0 and day 5 after surgery

  • Clinical score Postel Merle d'Aubigné

    2 months, 6 months and 12 months after surhery

  • Harris Hip score

    2 months, 6 months and 12 months after surgery

  • Oxford score

    2 months, 6 months and 12 months after surgery

Study Arms (2)

Cemented fixation

EXPERIMENTAL

Total hip replacement with cemented fixation

Procedure: Total hip replacement with cemented fixation

Non-cemented fixation

ACTIVE COMPARATOR

Total hip replacement with non-cemented fixation

Procedure: Total hip replacement with non-cemented fixation

Interventions

Total hip replacement with cemented fixationPROCEDURE

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.

Cemented fixation
Total hip replacement with non-cemented fixationPROCEDURE

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.

Non-cemented fixation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient needed a total hip arthroplasty

You may not qualify if:

  • Previous surgery on the affected hip
  • Preoperative anemia
  • Femoral neck fracture
  • Patient with a contraindication to tranexamic acid
  • Pregnant or breastfeeding patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique Jeanne d'Arc

Gien, 45500, France

Location

Clinique du Pré

Le Mans, 72000, France

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Laurent Abane, MD

    Clinique du Pré

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion Mandon, PhD

CONTACT

+336 78 27 76 72drc@vivalto-sante.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 25, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)