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

ConditionCoxarthrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • hip arthroplasty

    Procedure/Surgery

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

Treatment groups

165 Participants
are divided into 3 treatment groups
Group A: total hip arthroplasty (THA)1 intervention
Group B: Total hip prosthesis with femoral neck preservation1 intervention
Group C: Hip resurfacing1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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).

Time frame
3 months post-op
2

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).

Time frame
3 months then 1 year post-op
3

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.

Time frame
3 months post-op

Other outcomes

Sponsors and contacts

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