• Hand & Wrist Conditions
• Orthopaedics Clinical Trials
• Orthopaedic Procedures

• Hand & Wrist Conditions
• Orthopaedics
• Orthopaedics Clinical Trials
• Orthopaedic Procedures

Interim results from an ongoing trial showed that computer-assisted surgical (CAS) planning combined with patient-specific intraoperative guides reduced surgery and fluoroscopy times for distal radius corrective osteotomy and improved patient-reported outcomes. The technically difficult surgery has about a 17% incidence of distal radial malunion (DRM), said Natalie Leong, MD, University of California Los Angeles, Los Angeles, California, USA. This research group believes there is a positive correlation between quality of surgery and overall wrist function.

This is the first prospective, randomized, controlled trial of CAS for DRM and is being conducted at four institutions in the USA, Belgium, and Sweden [Leong NL et al. BMC Musculoskelet Disord 2010]. In the CAS patients, computed tomography (CT) scans of the bilateral forearm were used to make bony models, after which software determined the optimal osteotomy site and bony alignment by superimposing the malunited model onto the healthy contralateral model, and thereby determined the amount of correction needed. Then plastic customized intraoperative surgical guides were created using 3D printing. These guides were placed over the distal radius during the procedure and removed after surgery.

Patients who had extra-articular DRM and were >3 months post injury were randomized to usual corrective surgery (n=9) or CAS-guided surgery (n=7). Volar fixation along with osteotomy was performed in all patients. The use of bone grafting was left to the surgeon's discretion.

The mean operative time was reduced from 106 minutes in the control group to 78 minutes in the CAS group, and average fluoroscopy time was reduced from 226 to 31 msec, respectively (p<0.05).

Before surgery, there were no differences between groups for Disability of Arm, Shoulder, and Hand (DASH) scores, Patient-Rated Wrist Evaluation (PRWE) scores, and Visual Analog Scores for pain and for satisfaction. All patients reported improvement in these measures after surgery, although there was a trend for a greater improvement in the CAS group compared with the control group at 3, 6, and 12 months, said Dr. Leong.

In the CAS group, the DASH scores improved more at 3 and 6 months (by ∼30 to 35 points) compared with controls (∼15 to 20 points). PRWE scores improved ∼30 points with CAS compared with ∼22 points at 6 months, and were nearly similar at 12 months. At 3 months, patient satisfaction improved by 6.5 points with CAS compared with 4.1 points with control at 3 months, and these rates of improvement were maintained at 12 months. Pain scores improved by 6.0 points and 3.5 points at 3 months and by 7 points and nearly 4 points at 12 months with CAS and control, respectively.

There were no malunions or nonunions at 12 months. There was one case of contralateral wrist fracture at 6 months and one case of self-limiting extensor synovitis with CAS, and one case of complex regional pain syndrome and one case of extensor carpi ulnaris in the control group.

The interim results are promising, said Dr. Leong, and the goal is to complete 1-year follow-up in 40 patients. Other possible uses for the CAS approach are cold trauma and congenital deformities.

• © 2014 MD Conference Express®