Randomised clinical trial assessing migration of uncemented primary total hip replacement stems, with and without autologous impaction bone grafting.

Riaz Khan0 个研究点目标入组 100 人开始时间: 2018年4月24日最近更新: 2019年8月26日

适应症

试验速览

暂无简介。

•Inclusion Criteria
•1. The individual clinically qualifies for total hip arthroplasty surgery based on physical examination and medical history.
•2. The individual is diagnosed with an inflammatory or non inflammatory degenerative joint disease.
•3. The individual has not had a previous total hip replacement or hip fusion of the affected hip joint.
•4. The individual is physically and mentally willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation (i.e. not diagnosed with active significant psychiatric disorder, senile dementia, Alzheimer’s disease, presence of alcohol or substance abuse).
•5. The individual is skeletally mature.
•6. The individual has no plans to relocate to another geographic area before the completion of the study thus precluding scheduled follow-up.

•Exclusion Criteria
•1. The individual is unable or unwilling to sign the Patient Informed Consent specific to this study.
•2. The individual is less than 60 years of age.
•3. The individual is classified as morbidly obese (body mass index 40 or greater).
•4. The individual has an active infection within the considered hip joint.
•5. Any condition where quality of bone graft from the femoral head is poor and therefore not able to be used (e.g. avascular necrosis).
•6. The individual has a neuromuscular or neurosensory deficiency that limits the ability to evaluate the safety and effectiveness of the surgery.
•7. The individual has a diagnosed systemic disease that would affect the subject’s welfare or overall outcome of the study (i.e. Paget's disease, renal osteodystrophy), is not immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
•8. The individual is pregnant.
•9. The individual is a prisoner.

发起方