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

Coxarthrosis Clinical Trial

— HIP3D  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06272422
• Other study ID #: 2022/0472
• Secondary ID: 2023-A00358-37
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: University Hospital, Lille
• Contact: Julien GIRARD, MD
• Phone: +33 (0)3.20.44.68.28
• Email: julien.girard[@]chu-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 165
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coxarthrosis
• Osteoarthritis, Hip

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare the anatomical restoration of frontal and axial parameters between the 3 types of intervention (PTH, Minihip and RSA).	Difference between the contralateral healthy hip and the operated hip at 3 months post-op of the following parameters: frontal parameters: CCD angle (in degrees), limb length, LLL discrepancy (vertical femoral offset in mm), femoral or prosthetic head diameter, acetabulum inclination on the healthy side and cup inclination on the operated side, head-neck ratio (ratio between the diameter of the neck and the head of the femur).; axial parameters: femoral or prosthetic neck version, acetabulum version on healthy side and cup version on operated side, total version (neck + acetabulum or cup).	3 months post-op
Secondary	Compare clinical outcomes and patient satisfaction between the 3 procedures (PTH, Minihip and RSA).	Variations between the pre-operative and post-operative 3-month and 1-year periods in the following clinical parameters: Oxford, Harris, PMA, Devane, UCLA, Forgotten Joint Score Hip (FJS hip), joint amplitudes, ILMI clinical estimate (in cm); - Patient satisfaction: measured using a 4-item MCQ (dissatisfied, not very satisfied, satisfied, very satisfied) at 3 months (early recovery) and 1 year (definitive recovery).	3 months then 1 year post-op
Secondary	Correlate restoration of hip femoral offset and patient functional outcome at 3 months.	Offset restoration, defined as the difference between the native femoral offset, measured on the healthy contralateral hip, and the postoperative femoral offset of the operated hip.; - Patient functional outcome, defined by the Oxford score.	3 months post-op