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NCT Number: NCT06272422

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

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

Recruiting

Interested in participating?

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Key information

Conditions

Coxarthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hip arthroplasty

Procedure

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

Primary outcomes

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

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

    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.

Secondary outcomes

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

    Time frame: 3 months post-op

    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).

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

    Time frame: 3 months then 1 year post-op

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

    Time frame: 3 months post-op

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julien GIRARD, MD

CONTACT

[email protected]

+33 (0)3.20.44.68.28

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: HIP3D

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 22, 2024
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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