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A prospective, multicenter, randomized, parallel-controlled, superiority clinical trial evaluating the safety and efficacy of orthopaedic surgery planning software for preoperative planning of hip and knee replacements

A prospective, multicenter, randomized, parallel-controlled, superiority clinical trial evaluating the safety and efficacy of orthopaedic surgery planning software for preoperative planning of hip and knee replacements

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054260
Enrollment
Unknown
Registered
2021-12-12
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-11-14

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

Conditions

None listed

Interventions

Hip-experimental group:Orthopedic surgery planning software
Hip-control group:Preoperative planning was performed using a traditional surgical plan (based on X-ray and CT images)
Genus-experimental group:Orthopedic surgery planning software
Genus-control group:Preoperative planning was performed using a traditional surgical plan (based on X-ray and CT images)

Sponsors

The First Medical Center of the PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years (including 18 and 80 years old), gender is not limited; 2. According to the clinical judgment of the research doctor, in line with the indications for hip and knee joint replacement surgery (such as: primary or secondary osteoarthritis, avascular necrosis of the femoral head, femoral neck fracture, etc.); 3. Preoperative images (X-rays, CT images) meet the requirements for preoperative planning; 4. Understand the purpose of the trial, follow the protocol, participate voluntarily and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects who are pregnant or breastfeeding, or who plan to conceive during the test, with positive blood/urine pregnancy test results before the test; 2. Subjects who have participated in other clinical trials within 3 months before enrollment in this trial or are currently participating in other clinical trials (except for registration studies in other clinical trials); 3. Other situations judged by the researchers that are not suitable for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
Complete accuracy;

Secondary

MeasureTime frame
Accuracy;Software ease of use;Software functionality;Complete accuracy of ball head of hip joint, acetabular lining and knee gasket;Adverse events, serious adverse events;Equipment defects;

Countries

China

Contacts

Public ContactChai Wei

The First Medical Center of the PLA General

chaiwei301@163.com+86 13909915960

Outcome results

None listed

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