Digital Three-dimensional Imaging Models for Repair of Complex Long Bone Fractures: a Randomized Controlled Trial With 6-month Follow-up

History and current related studies The internal fixator is difficult to completely fit the bone surface at the site of complex long bone fracture, which reduces the firmness of fixation. From a safety point of view, the establishment of a digital three-dimensional measurement model is undoubtedly a very reliable and intuitive way. Digital three-dimensional models are established after CT scan, and these models can greatly reflect the site and degree of fractures, and reduce anatomical parameters, with high degree of simulation and feasibility.

Adverse events

1. The investigators will record adverse events, including screw loosening and falling off, steel plate fracture and bending, joint stiffness, delayed healing or non-healing, peripheral nerve injury and infection.
2. If severe adverse events occur, investigators will report details, including the date of occurrence and measures taken to treat the adverse events, to the principle investigator and the institutional review board within 24 hours.

Data collection, management, analysis and open-access

1. Data collection: Case report forms with demographic data, disease diagnosis, accompanying diseases, drug allergy history, and adverse events will be collected, processed using Epidata software (Epidata Association, Odense, Denmark), collated, and then recorded electronically by data managers using a double-data entry strategy.
2. Data management: The locked electronic database will be accessible and locked only by the project manager, and will not be altered. All data regarding this trial will be preserved by the Affiliated Hospital of Qinghai University, China.
3. Data analysis: The electronic database will be statistically analyzed by a professional statistician who will create an outcome analysis report that will be submitted to the lead researchers. An independent data monitoring committee will supervise and manage the trial data, ensuring a scientific and stringent trial to yield accurate and complete data.
4. Data open access: Anonymized trial data will be published at www.figshare.com.