Comparison of the Restoration of Hip Biomechanical Parameters by CT Measurement Between the 3 Surgical Techniques: RSA/Minihip/THA - Hip Replacement: 3D Planning (HIP3D)

University Hospital, Lille

Status: Not yet enrolling

Conditions: Coxarthrosis

Treatments: Procedure: hip arthroplasty

Study type: Observational

Funder types: Other

Identifiers

NCT06272422

2022/0472

2023-A00358-37 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

165 participants in 3 patient groups

total hip arthroplasty (THA)

Description:

Standard THA, the head and neck of the femur are cut.

Treatment:

Procedure: hip arthroplasty

Total hip prosthesis with femoral neck preservation

Description:

A total hip replacement is performed, but the neck of the femur is preserved and the head of the femur is cut off.

Treatment:

Procedure: hip arthroplasty

Hip resurfacing

Description:

the head and neck of the femur are preserved.

Treatment:

Procedure: hip arthroplasty