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Clinical Trials in France / NCT06272422
Recruiting Observational

Comparison of the Restoration of Hip Biomechanical Parameters by CT Measurement Between the 3 Surgical Techniques: RSA/Minihip/THA - Hip Replacement: 3D Planning

NCT06272422 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Lille
Phase
Observational
Started
2024-05-27
Last updated
2026-05-19

Condition(s) studied

Coxarthrosis

Investigational drug(s) / intervention(s)

hip arthroplasty

hip arthroplasty: resurfacing procedures (HRP), THA and Minihip-type neck-preserving total hip arthroplasty.

Study summary

The study will analyze hip biomechanical parameters using EOS radiographic measurements pre- and post-operatively (3 months) and post-operatively (3 months) CT scans after total hip replacement (THR), neck-preserving THR of the Minihip type or hip resurfacing (HR). Clinical results will be assessed at 3 months and 1 year after surgery.

To this end, two types of examination are carried out, both of which are used in current practice:

* Pre-operatively: EOS radiography
* Post-operatively: EOS radiograph and CT scan

Inclusion (m-3; m-1) :

* Patient information at pre-operative visit
* Non-opposition of patient, family member or legal guardian, if applicable
* Questionnaires and clinical examination (standard management)
* EOS during anesthetic consultation

Follow-up visit (m+3):

\- Post-operative follow-up consultation EOS and CT scan (1 week prior to visit) + questionnaire and clinical examination

Follow-up visit (m+12):

\- Post-operative check-up, questionnaire and clinical examination

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male or female * Age ≥ 18 years * Planned surgery: total hip arthroplasty, Minihip or RSA * Absence of osteoarthritis or osteoarthritis ≤ stage 1 (Tönnis classification) of contralateral hip (Radiographic analysis) * Patient having given his/her non-opposition to participate in the study * Patient with social insurance * Patient willing to comply with all study procedures and duration Exclusion Criteria: * Patient with comorbidity(ies) likely to affect biomechanical parameter measurements or surgical conditions: * Anomalies or anatomical changes of the hip, pelvis or lumbar spine (history of fracture, protrusion, scoliosis, history of orthopedic surgery, dysplasia, torsion disorder) * Established genetic disease affecting the musculoskeletal system * Severe or morbid obesity * Neuromuscular pathologies affecting the limb girdles * Severe osteoporosis * Bone location of primary or metastatic cancer (spine, pelvis or femur) - Inequality of lower limb length \> 2 cm. * Minors * Protected adults * Pregnant or breast-feeding women * Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to participate.

Primary outcome measure(s)

  • Comparing the restoration of femoral hip offset between hip resurfacing procedures (HRP), THA and Minihip-type neck-preserving total hip arthroplasty. — It will be measured using CT scans at 3 months post-op for each hip.
    The primary endpoint will be the difference between the native femoral offset, measured on the healthy contralateral hip, and the postoperative femoral offset of the operated hip. The offset is the distance in millimeters between the axis of the femoral shaft and the center of the femoral head.

Trial sites (1)

FacilityCityRegionStatus
chu de Lille Lille France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06272422 on ClinicalTrials.gov ↗ ← All trials in France