Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-25 @ 3:13 AM
NCT ID:
NCT05929105
Eligibility Criteria:
Inclusion Criteria:
* DDH was diagnosed by clinical signs and imaging examination, and a primary THA was planned;
* the patient had persistent unilateral hip pain, which seriously affected their quality of life;
* the standard posterolateral approach was used;
* the contralateral hip was normal or had received THA;
* the proximal femoral Dorr classification was type A or B;
* The acetabular classification was Crowe type Ⅰ, Ⅱ, Ⅲ or IV;
* all patients were treated with the bioartificial hip joint PINNACLE® cup or SUMMIT® stem, developed by Johnson \& Johnson Biological.
Exclusion Criteria:
* preoperative and postoperative imaging examinations did not meet the evaluation criteria (non-standard double-hip anteroposterior film, acetabular angle and LL length could not be accurately measured);
* severe osteoporosis, tumour or metabolic disease around the affected hip joint;
* spinal deformity by other causes or a history of lumbar internal fixation;
* external deformity of the affected hip joint in the lower extremity;
* neuromuscular insufficiency (with hip abduction weakness and poliomyelitis);
* severe disease with intolerance to surgery.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05929105
Study Brief:
Protocol Section:
NCT05929105