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

NCT ID: NCT06272422

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 165 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2026-03-31

Brief 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

Conditions

Coxarthrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

total hip arthroplasty (THA)

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

hip arthroplasty

Intervention Type: PROCEDURE

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

Total hip prosthesis with femoral neck preservation

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

hip arthroplasty

Intervention Type: PROCEDURE

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

Hip resurfacing

the head and neck of the femur are preserved.

hip arthroplasty

Intervention Type: PROCEDURE

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

Interventions

hip arthroplasty

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Julien GIRARD, MD

Role: CONTACT

julien.girard@chu-lille.fr

+33 (0)3.20.44.68.28

Other Identifiers

2023-A00358-37

Identifier Type: OTHER

Identifier Source: secondary_id

2022/0472

Identifier Type: -

Identifier Source: org_study_id