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

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2021
INTERVENTION: 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); CONDITION: N/A PRIMARY OUTCOME: Complete accuracy; SECONDARY OUTCOME: 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; 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.
Epistemonikos ID: 47358ca5ba97658e829611879e0a8eba65f7df8b
First added on: Dec 20, 2022