Three Dimensional Digital Preoperative Planning for the Osteosynthesis of Distal Radius Fractures
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02909647 |
Recruitment Status :
Recruiting
First Posted : September 21, 2016
Last Update Posted : April 27, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Distal Radius Fracture | Procedure: Preoperative planning Procedure: Osteosynthesis | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Three Dimensional Digital Preoperative Planning for the Osteosynthesis of Distal Radius Fractures |
Study Start Date : | January 2014 |
Estimated Primary Completion Date : | May 2024 |
Estimated Study Completion Date : | May 2025 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Plan group
3D preoperative planning for the distal radius fracture was performed prior to the osteosynthesis.
|
Procedure: Preoperative planning
preoperative planning using 3D digital planning software or conventional template Procedure: Osteosynthesis osteosynthesis using volar locking plate |
Active Comparator: Control group
Conventional preoperative planning for the distal radius fracture was performed prior to the osteosynthesis.
|
Procedure: Preoperative planning
preoperative planning using 3D digital planning software or conventional template Procedure: Osteosynthesis osteosynthesis using volar locking plate |
- Intraclass correlation coefficients between preoperative plan and after surgery [ Time Frame: 1 week ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- the patients who have distal radius fracture in their unilateral wrist.
Exclusion Criteria:
- the patients who reported a previous history of traumatic injuries to the arm.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909647
Contact: Yuichi Yoshii | +81-29-887-1161 | yy12721@yahoo.co.jp |
Japan | |
Tokyo Medical University Ibaraki Medical Center | Recruiting |
Ami, Ibaraki, Japan, 300-0395 | |
Contact: Yuichi Yoshii 81298871161 yyoshii@tokyo-med.ac.jp |
Principal Investigator: | Yuichi Yoshii | Tokyo Medical University |
Responsible Party: | Yuichi Yoshii, Associate Professor, Tokyo Medical University |
ClinicalTrials.gov Identifier: | NCT02909647 |
Other Study ID Numbers: |
14-21 |
First Posted: | September 21, 2016 Key Record Dates |
Last Update Posted: | April 27, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Fractures, Bone Radius Fractures Wrist Fractures Wounds and Injuries |
Forearm Injuries Arm Injuries Wrist Injuries |