Developmental dysplasia of the hip
Conditions
Interventions
Group 1:Transverse subtrochanteric shorting osteotomy combined total hip arthroplasty via the direct anterior approach with AI planning
Sponsors
Fuzhou Second Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is a patient with Crowe type IV developmental dysplasia of the hip (DDH) according to the Crowe classification criteria; 2. The subject is a patient undergoing primary total hip arthroplasty and is suitable for total hip arthroplasty and subtrochanteric transverse osteotomy using the devices described in the clinical trial protocol; 3. The subject has a bilateral lower limb length difference of >= 3 cm and the preoperative planning results are suitable for the subtrochanteric osteotomy technique; 4. 18-85 years of age; 5. The subject meets the criteria described in the instructions for the biotype S-ROM femoral stem component; 6. The subject, in the judgement of the clinical investigator, understands the clinical study and is able to cooperate with the study process; 7. The subject is willing and able to sign an informed consent form approved by an Institutional Review Board (IRB), Ethics Committee (EC) or Ethical Review Board (ERB) prior to the start of the study; 8. The subject is able to formulate, read and understand the questions in the subjective questionnaire specified in the study protocol and is able to provide feedback in appropriate language.
Exclusion criteria
Exclusion criteria: 1. Obesity with a BMI > 35; 2. Patients with excessive expectations in terms of pain relief, gait recovery and limb length; 3. Shortening of the affected limb by less than 1 cm; 4. History of surgery at the surgical site; 5. Patients who are physically and mentally unfit to cooperate with the trial and cannot provide written consent for voluntary participation in the clinical study; 6. The subject is a pregnant or lactating woman; 7. Any previously implanted artificial hip device is present in the affected hip joint; 8. The affected hip has undergone femoral head and neck resection (Girdlestone) or surgical fusion; 9. Above-knee amputation of the contralateral or ipsilateral lower limb; 10. Subject has an active infection; 11. Subject has a medical condition or adverse health condition that, in the opinion of the investigator, may interfere with participation in the study, such as malignant disease, serious illness, alcohol or drug addiction, and/or mental disorder; 12. The subject has severe osteoporosis, metabolic bone disease, radiological bone disease, or periprosthetic tumours which, in the opinion of the investigator, would negatively affect endophyseal fixation or the outcome of the study; 13. The subject has a severe neurological or musculoskeletal disorder that may affect gait or weight bearing, (e.g. myasthenia gravis, multiple sclerosis, cerebral infarction, hemiplegia, Charcot's disease); 14. The subject is unable to formulate, read and understand the questions on the subjective questionnaire specified in the study protocol and is unable to provide feedback in appropriate language; 15. The subject has other medical conditions and has a life expectancy of less than 2 years; 16. The subject has other comorbidities that limit participation in the study, prevent compliance with follow-up or affect the scientific integrity of the study; 17. The subject is currently participating in another clinical study with a drug or device; 18. The subject is serving a prison sentence; 19. The subject is known to be allergic to any component of the endophyte (e.g. metal); 20. Patients for whom DAA access is considered inappropriate by other lead surgeons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index;Leg length discrepancy;The hip center of rotation (horizontal distances and vertical distances);Femoral offset; | — |
Secondary
| Measure | Time frame |
|---|---|
| Operation time;Blood transfusion rate;Reach the standard days of discharge after surgery; | — |
Countries
China
Contacts
Public ContactEeyou Feng
Fuzhou Second Hospital
Outcome results
None listed