Computer-assisted versus non-computer-assisted preoperative planning of corrective osteotomy for extra-articular distal radius malunions: a randomized controlled trial
Open Access
- 14 December 2010
- journal article
- research article
- Published by Springer Science and Business Media LLC in BMC Musculoskeletal Disorders
- Vol. 11 (1), 282
- https://doi.org/10.1186/1471-2474-11-282
Abstract
Background Malunion is the most common complication of distal radius fracture. It has previously been demonstrated that there is a correlation between the quality of anatomical correction and overall wrist function. However, surgical correction can be difficult because of the often complex anatomy associated with this condition. Computer assisted surgical planning, combined with patient-specific surgical guides, has the potential to improve pre-operative understanding of patient anatomy as well as intra-operative accuracy. For patients with malunion of the distal radius fracture, this technology could significantly improve clinical outcomes that largely depend on the quality of restoration of normal anatomy. Therefore, the objective of this study is to compare patient outcomes after corrective osteotomy for distal radius malunion with and without preoperative computer-assisted planning and peri-operative patient-specific surgical guides. Methods/Design This study is a multi-center randomized controlled trial of conventional planning versus computer-assisted planning for surgical correction of distal radius malunion. Adult patients with extra-articular malunion of the distal radius will be invited to enroll in our study. After providing informed consent, subjects will be randomized to two groups: one group will receive corrective surgery with conventional preoperative planning, while the other will receive corrective surgery with computer-assisted pre-operative planning and peri-operative patient specific surgical guides. In the computer-assisted planning group, a CT scan of the affected forearm as well as the normal, contralateral forearm will be obtained. The images will be used to construct a 3D anatomical model of the defect and patient-specific surgical guides will be manufactured. Outcome will be measured by DASH and PRWE scores, grip strength, radiographic measurements, and patient satisfaction at 3, 6, and 12 months postoperatively. Discussion Computer-assisted surgical planning, combined with patient-specific surgical guides, is a powerful new technology that has the potential to improve the accuracy and consistency of orthopaedic surgery. To date, the role of this technology in upper extremity surgery has not been adequately investigated, and it is unclear whether its use provides any significant clinical benefit over traditional preoperative imaging protocols. Our study will represent the first randomized controlled trial investigating the use of computer assisted surgery in corrective osteotomy for distal radius malunions. Trial registration NCT01193010This publication has 28 references indexed in Scilit:
- Complex Radius Shaft Malunion: Osteotomy with Computer-Assisted PlanningHAND, 2010
- CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized TrialsAnnals of Internal Medicine, 2010
- Corrective Osteotomy for Malunited Intra-Articular Fracture of the Distal Radius Using a Custom-Made Surgical Guide Based on Three-Dimensional Computer Simulation: Case ReportThe Journal of Hand Surgery, 2008
- Osteoarthritis of the WristThe Journal of Hand Surgery, 2007
- Corrective Osteotomy for Intra-Articular Malunion of the Distal Part of the RadiusJournal of Bone and Joint Surgery, 2005
- CT virtual reality in the preoperative workup of malunited distal radius fractures: preliminary resultsEuropean Radiology, 2004
- Responsiveness of the disability of the arm, shoulder, and hand (DASH) and patient-rated wrist/hand evaluation (PRWHE) in evaluating change after hand therapyJournal of Hand Therapy, 2004
- Computer-generated bone models in the planning of osteotomy of multidirectional distal radius malunionsThe Journal of Hand Surgery, 1992
- Effects of distal radius fracture malunion on wrist joint mechanicsThe Journal of Hand Surgery, 1990
- Trapezoidal osteotomy of the distal radius for unacceptable articular angulation after Colles' fractureThe Journal of Hand Surgery, 1988