Clinical Trial: Three Dimensional Digital Preoperative Planning for the Osteosynthesis of Distal Radius Fractures

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Three Dimensional Digital Preoperative Planning for the Osteosynthesis of Distal Radius Fractures

Brief Summary:

Background: Three dimensional (3D) digital pre-operative planning software for osteosynthesis of fractures was developed. To assess the usefulness of the 3D planning, we evaluated the accuracy of the reduction shapes and selected implants in the patients with distal radius fractures.

Methods: Thirty wrists of 30 distal radius fracture patients who underwent osteosynthesis using volar locking plates were evaluated. Fifteen wrists were treated with 3D preoperative planning as the plan group. The other fifteen wrists were treated with conventional preoperative planning as the control group. Volar tilt and radial inclination were measured after operation and compared with the healthy side wrist. In addition, preoperative planning and postoperative reductions were compared by measuring the volar tilt and radial inclination of the 3D images in the plan group. The intra-class correlation coefficient (ICC) values of the radiological parameters between healthy side wrists and injured side wrists, between preoperative planning and postoperative reductions were evaluated. For the accuracy of the implant choices, the ICCs for the screw lengths between the preoperative plan and the actual choices were evaluated in the plan group.

Detailed Summary:

Patients and Methods The study protocol was approved by our Institutional Review Board. Thirty wrists of 30 distal radius fracture patients who underwent osteosynthesis using locking plates (19 females, 11 males; age range 23-89, mean age 59.5 years) were evaluated. Patients were excluded if they reported a previous history of traumatic injuries to the arm. The patients were divided into two groups: 15 patients in the plan group utilized our 3D digital preoperative planning software, and 15 patients in the control group utilized standard preoperative assessment on plain radiographs and CT scans. The age, sex, and fracture types were matched between groups. According to the preoperative CT scans, fractures were classified using the AO classification system.

Preoperative Planning In the plan group, 3D digital preoperative planning and a surgical simulation were performed in order to determine the reduction and the placement of the implants in addition to the plate/screw size prior to surgery. Reduction and placement of the implants were simulated using software newly-developed by the authors (Zed-Trauma, LEXI Co., Ltd. Tokyo, Japan). Planning using this software is based on digital imaging and communications in medicine (DICOM) data from CT scans. All preoperative planning group patients had pre- and post-operative CT scans in order to compare the planned and post-operative reduction shape and placement of the implant. The CT comprised contiguous sections of 1 mm thickness. The software allows the surgeons to 1) visualize the fracture displacement, 2) simulate repositioning of the fragments, 3) place the plate and screws, 4) adjust the sizes of the implants, and 5) check the shape after the reduction and implant placement by measuring anatomical shape (Figure 1 and 2). After importing the DICOM images to the software, a 3D image of the distal radius was made. Each distal ra
Sponsor: Tokyo Medical University

Current Primary Outcome: Intraclass correlation coefficients between preoperative plan and after surgery [ Time Frame: 1 week ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Tokyo Medical University

Dates:
Date Received: September 14, 2016
Date Started: January 2014
Date Completion:
Last Updated: September 21, 2016
Last Verified: September 2016