Comparison of the Restoration of Hip Biomechanical Parameters by CT Measurement Between the 3 Surgical Techniques: RSA/Minihip/THA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Comparing the restoration of femoral hip offset between hip resurfacing procedures (HRP), THA and Minihip-type neck-preserving total hip arthroplasty.
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •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.
结局指标
主要结局
Comparing the restoration of femoral hip offset between hip resurfacing procedures (HRP), THA and Minihip-type neck-preserving total hip arthroplasty.
时间窗: 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.
次要结局
- 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)