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

NCT06272422 | Not Yet Recruiting

• 2 other identifiers: 2022/04722023-A00358-37
• Study Type: observational
• Target: 165
• Locations: 0 countries
• Sites: N/A

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

Keywords

Arthroplasty hip; femoral offset; resurfacing; EOS; 3D

Outcome Measures

Primary Outcomes (1)

• Comparing the restoration of femoral hip offset between hip resurfacing procedures (HRP), THA and Minihip-type neck-preserving total hip arthroplasty.

  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.

  It will be measured using CT scans at 3 months post-op for each hip.

Secondary Outcomes (3)

• Compare the anatomical restoration of frontal and axial parameters between the 3 types of intervention (PTH, Minihip and RSA).

  3 months post-op

• Compare clinical outcomes and patient satisfaction between the 3 procedures (PTH, Minihip and RSA).

  3 months then 1 year post-op

• Correlate restoration of hip femoral offset and patient functional outcome at 3 months.

  3 months post-op

Study Arms (3)

total hip arthroplasty (THA)

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

Procedure: 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.

Procedure: hip arthroplasty

Hip resurfacing

the head and neck of the femur are preserved.

Procedure: hip arthroplasty

Interventions

hip arthroplasty PROCEDURE

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

Hip resurfacing; Total hip prosthesis with femoral neck preservation; total hip arthroplasty (THA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients, primary care clinic at Lille University Hospital, single-center study

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

Julien GIRARD, MD

CONTACT

+33 (0)3.20.44.68.28; julien.girard@chu-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: October 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: July 10, 2024

Record last verified: 2024-07