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A Randomized Controlled Trial of Simultaneous versus Staged Bilateral Total Hip Arthroplasty in Patients with Bilateral Developmental Dysplasia of the Hip (DDH)

A Randomized Controlled Trial of Simultaneous versus Staged Bilateral Total Hip Arthroplasty in Patients with Bilateral Developmental Dysplasia of the Hip (DDH)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107887
Enrollment
Unknown
Registered
2025-08-20
Start date
2025-08-20
Completion date
Unknown
Last updated
2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Developmental Dysplasia of the Hip

Interventions

One-stage replacement group:Bilateral total hip arthroplasty was performed under a single anesthesia
Two-stage replacement group:A unilateral total hip arthroplasty was performed under anesthesia once, and a total hip arthroplasty on the other side was carried out again after some time

Sponsors

Chinese PLA general hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. The subjects were patients with bilateral DDH. 2. Age: 18 to 85 years old. 3. According to the judgment of the clinical researchers, the subjects can understand this clinical study and cooperate to complete the research process. 4. Before the start of the study, the subjects were willing and able to sign the informed consent form approved by the Institutional Review Board (IRB), Ethics Committee (EC), or Ethics Review Board (ERB). 5. The subjects are capable of expressing, reading and understanding the questions in the subject subjective questionnaire stipulated in the research protocol, and can provide feedback information in appropriate language.

Exclusion criteria

Exclusion criteria: 1. Patients with high expectations of pain relief, gait recovery, and limb length. 2. Patients who are physically and mentally unhealthy and unable to cooperate with the trial cannot provide written consent to voluntarily participate in the clinical study. 3. Subjects are pregnant or lactating women. 4. The affected hip joint has undergone Girdlestone or surgical fusion. 5. Amputation above the knee joint of the contralateral or ipsilateral lower limb. 6. Subject has an active infection. 7. Subjects have diseases or adverse health conditions that the investigator believes may affect their participation in this study, such as malignant diseases, serious illnesses, alcohol or drug addiction, and/or mental disorders. 8. Subjects suffer from severe osteoporosis, metabolic bone disease, radiation bone disease, or perihip tumors that the investigator believes have a negative impact on internal plant fixation or research results. 9. Subject has a severe neurological or musculoskeletal disease that may affect gait or weight bearing, (e.g.: muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot's disease). 10. Subjects cannot express, read, and understand the questions in the subjective questionnaire specified in the study protocol, and cannot provide feedback in appropriate language. 11. Subjects suffer from other diseases and have a life expectancy of less than 2 years. 12. Other diseases combined with the subject restrict their participation in the study, unable to comply with follow-up or affect the scientific integrity of the study. 13. Subject is currently participating in another drug or device clinical study. 14. Subject is serving a sentence. 15. Subject is known to be allergic to any component of the endoplant (e.g., metal).

Design outcomes

Primary

MeasureTime frame
Harris score;

Secondary

MeasureTime frame
SF-12 score;VAS score;BPFS score;ASA score;Time of operation;Peroperative bleeding;All-in cost;

Countries

China

Contacts

Public ContactChai Wei

Chinese PLA general hospital

chaiwei301@163.com+86 136 0137 2998

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026