Diseases with indications for total hip arthroplasty secondary to developmental dysplasia of hip
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18 ~ 80 years old, regardless of gender; 2.Patients who meet the requirements of total hip arthroplasty secondary to DDH and need the primary total hip arthroplasty according to the evaluation of the researchers; 3.The subjects fully understand the benefits and risks of this trial and are willing to participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with neuromuscular dysfunction (e.g., paralysis, myolysis or abductor weakness) that can lead to postoperative hip instability or abnormal gait; 2.Active infection lesions in the hip joint or other parts of the body; 3.Patients with severe hip deformity and hip dysplasia with Crowe grade 3 or 4; 4.Ankylosing spondylitis patients with bony ankylosis or severe stiffness; 5.Patients with bilateral hip arthroplasty at the same time, or patients with contralateral hip arthroplasty within 3 months, or patients with contralateral hip arthroplasty expected to be performed within 1 year after operation; 6.The patient known to have a history of allergy to one or more implanted materials. 7.Patients with severe internal and surgical diseases or weak physique and unable to tolerate surgery; 8.Patients with poor expected compliance; 9. Pregnant or lactating women, or patients with family planning during clinical research; 10.The patient participating in other drug clinical trials within 3 months before enrollment, or other device clinical trials within 1 month before enrollment; 11.Other circumstances that the researchers consider inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acetabular coverage (postoperative CT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Prosthesis size;Acetabular (planned size, actual size);Acetabular abduction angle(planned size, actual size);Accuracy of acetabular cup implantation;Percentage of acetabular cup implantation safety zone;Acetabular eccentricity (planned size, actual size);Horizontal distance of hip rotation center (preoperative, postoperative and bilateral);Vertical distance of hip rotation center (preoperative, postoperative and bilateral);difference in the length of both lower limbs; | — |
Countries
China