Clinical trial NCT06272422: Comparison of the Restoration of Hip Biomechanical Parameters by CT Measurement Between the 3 Surgical Techniques: RSA/Minihip/THA - Hip Replacement: 3D Planning
Official title: Comparison of the Restoration of Hip Biomechanical Parameters by CT Measurement Between the 3 Surgical Techniques: RSA/Minihip/THA
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coxarthrosis
Keywords: Arthroplasty hip
femoral offset
resurfacing
EOS
3D
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients, primary care clinic at Lille University Hospital, single-center study

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


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.

Primary outcomes:
measure: Comparing the restoration of femoral hip offset between hip resurfacing procedures (HRP), THA and Minihip-type neck-preserving total hip arthroplasty.
timeFrame: It will be measured using CT scans at 3 months post-op for each hip.
Secondary outcomes:
measure: Compare the anatomical restoration of frontal and axial parameters between the 3 types of intervention (PTH, Minihip and RSA).
timeFrame: 3 months post-op
measure: Compare clinical outcomes and patient satisfaction between the 3 procedures (PTH, Minihip and RSA).
timeFrame: 3 months then 1 year post-op
measure: Correlate restoration of hip femoral offset and patient functional outcome at 3 months.
timeFrame: 3 months post-op
Other outcomes:
Locations:
Study officials:
References: