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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

• Comparing the restoration of femoral hip offset between hip resurfacing procedures (HRP), THA and Minihip-type neck-preserving total hip arthroplasty. [Срок оценки: It will be measured using CT scans at 3 months post-op for each hip.]

Вторичные конечные точки (3)

• Compare the anatomical restoration of frontal and axial parameters between the 3 types of intervention (PTH, Minihip and RSA). [Срок оценки: 3 months post-op]
• Compare clinical outcomes and patient satisfaction between the 3 procedures (PTH, Minihip and RSA). [Срок оценки: 3 months then 1 year post-op]
• Correlate restoration of hip femoral offset and patient functional outcome at 3 months. [Срок оценки: 3 months post-op]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• chu de Lille — Lille

Идентификаторы

NCT: NCT06272422 · 2022/0472 · 2023-A00358-37

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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