Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02909647 |
| Other study ID # |
14-21 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2014 |
| Est. completion date |
May 2025 |
Study information
| Verified date |
April 2022 |
| Source |
Tokyo Medical University |
| Contact |
Yuichi Yoshii |
| Phone |
+81-29-887-1161 |
| Email |
yy12721[@]yahoo.co.jp |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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 radius fracture was
segmented according to the main fracture fragments using the cut function. Each fragment was
repositioned in accordance with fracture lines. After repositioning the fragments, the bone
shape was checked three dimensionally. Reduction of the fragment was performed to regain the
volar tilt and the radial inclination, and less than 2mm step-off for the intra-articular
displacement referring to the healthy side wrist X ray. Simulation of the implantation of the
volar locking plate used 3D templates with variable sizes of plates and screws. The Stellar
II locking plate (HOYA Technosurgical, Inc., Tokyo, Japan) was used in this study. This plate
system has small, medium, and large sizes for the width, and short and long sizes for the
plate length. Screw lengths from 10 to 24 mm for the distal (2.4 mm diameter), and 10 to 20
mm for the proximal (2.6 mm diameter) are available. Computer aided design models of
different-sized implants were installed in the software. The plate size was chosen to cover
the distal fragment maximally and not exceeded the width of the distal radius. The plans were
made by a single hand surgeon. After the planning, osteosynthesis was performed under general
anesthesia. During the surgery, the operator performed the reduction and the placement of the
plate while comparing images between the preoperative plan and fluoroscopy. The surgeons
tried to reproduce the planned position of the implant by checking the distances from the
margin of the implant to the margin of the radius under fluoroscopy. The screw sizes were
determined by intraoperative measurement in reference to the preoperative plan. For the screw
fixation, a guide block was used to insert the distal screws.
In the control group, preoperative planning was performed using conventional
posterior-anterior and lateral view radiographs. Based on the X-ray image, the plate size was
chosen using the conventional template. After the planning, osteosynthesis was performed
under general anesthesia in the same manner as for the plan group. The surgeries were
performed by several residents and fellows under supervision of a hand surgeon.
Evaluations The planned sizes of implant were compared with the actual sizes used at
operation in the plan group. The screw holes were numbered from 1 to 8 for the distal (there
were 7 holes in small and medium plates, and 8 holes in a large plate), and from 1 to 3 for
the proximal. The screw lengths actually chosen were recorded according to the screw number.
To evaluate the accuracy of the anatomical reduction, volar tilt and radial inclination of
the post-operative wrists X-ray were compared with those of the healthy side wrist in both
plan and control groups. The posterior-anterior view was obtained with the elbow flexed at
90°, the ulna perpendicular to the humerus, and the forearm in the pronated position. The
lateral view was obtained with the elbow flexed at 90° and adducted against the trunk. The
wrists were in a neutral position with no flexion, extension, or deviation in either view.
Volar tilt was measured on a lateral view. The angle between a line along the distal radial
articular surface and the line perpendicular to the longitudinal axis of the radius at the
joint margin was measured as volar tilt. Radial inclination was measured on a
posterior-anterior view. The angle between one line connecting the radial styloid tip and the
ulnar aspect of the distal radius and a second line perpendicular to the longitudinal axis of
the radius was measured as radial inclination. These radiological parameters were measured by
a single hand surgeon. 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 (Figure 3). The axis of the radius was adjusted. The angle between a line from the
dorsal edge to the volar edge of the radius and the line perpendicular to the longitudinal
axis of the radius was measured as 3D volar tilt. The angle between a line from the radial
styloid tip to the ulnar aspect of the distal radius and the line perpendicular to the
longitudinal axis of the radius was measured as 3D radial inclination.
Statistical Analysis The results are expressed as mean +/- standard deviation. An intra-class
correlation coefficient (ICC) was used to evaluate the accuracy of the anatomical reduction.
The ICC values of the radiological parameters (volar tilt and radial inclination) between
healthy side wrists and injured side wrists after the surgery were evaluated in both the plan
and control groups. In addition, the ICCs of the 3D measurements between the pre-operative
plan and the post-operative 3D images were evaluated in the plan group.
For the accuracy of the implant choices, the ICCs for the screw lengths between the
preoperative plan and the actual choices were evaluated. According to the previous
recommendation12, ICC less than 0.40 was considered poor reproducibility, between 0.40 and
0.59 was considered moderate, between 0.60 and 0.74 was considered good, and between 0.75 and
1.00 was considered excellent. The differences between preoperative plan and postoperative
reductions, healthy side and injured side after surgery were analyzed using the paired
t-test. P values of <0.05 were considered significant. All analyses were performed using SPSS
version 13.0 (SPSS, Chicago, IL, USA).
