acetabular defects in revision hip arthroplasty
Conditions
Interventions
control group:The control group used a traditional surgical approach with preoperative manual segmentation and manual 3D planning. After review by the operator, the augment .STL was generated and sen
The trial group:The trial group used AI-revision software for prospective preoperative planning, including sizing of the acetabular cup prosthesis, and intelligently generating a augment suitable for
Sponsors
The Fourth Medical Center, PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: ? The subject is 18-75 years of age; ? The Subject is skeletally mature; ? The subject should have an indication for total hip revision surgery, and the acetabular defect is obvious and needs to be reconstructed with a cushion; ? Prior to surgery, the subject is willing and able to sign an informed consent form.
Exclusion criteria
Exclusion criteria: ? The subject's neuromuscular insufficiency (e.g., paralysis, rhabdomyolysis, or adductor weakness) will result in postoperative hip instability or gait abnormalities; ? The subject is mentally incapacitated or unable to understand the requirements for participation in the study; ? Alcoholics or drug addicts, substance abusers; ? Obese (BMI > 35); ? Poorly controlled diabetes (fasting blood glucose = 8.0 mmol/L with medication control); ? Severe hepatic and renal insufficiency, defined as: ALT or ALT > 2.5 times the upper limit of normal; serum creatinine > upper limit of normal; ? The subject is known to have a history of allergy to one or more of the implanted materials; ? Active infectious disease in the hip joint or other parts of the body; ? Severe osteoporosis, metabolic bone disease, radiological bone disease, tumor around the hip joint; ?Pregnant or lactating women or women who plan to pregnant within 12 months; ?Systemic diseases (including coagulation disorders, severe heart diseases, severe respiratory diseases, and others who cannot tolerate anesthesia or surgery); those who are frail or cannot tolerate surgery due to other systemic diseases, and those whose life expectancy is less than 2 years; ? The subject has participated in other drugs, biologics or medical devices clinical studies before enrollment and has not met the time limit of the primary study endpoint; ? The subject's comorbid other diseases that limit his/her participation in the study and prevent him/her from complying with the follow-up visits, thus affecting the scientific integrity of the study; ? The subject does not cooperate with or is unfavorable to the treatment and postoperative rehabilitation exercises, and is expected to have poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Augment location compliance;Augment volume compliance;Superior migration distance of hip center;Prosthesis loosening/migrating rate;Prosthesis compliance;Augment compliance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Harris Hip Score;WOMAC index;Forgotten Joint Score;Limb length discrepancy;Postoperative complication rate;Re-revision rate;Surgery planning time; | — |
Countries
China
Contacts
Public ContactWei Chai
The Fourth Medical Center of People’s Liberation Army General Hospital, Beijing, China
Outcome results
None listed