Early Functional Postoperative Therapy of Distal Radius Fracture with a Dynamic Orthosis: Results of a Prospective Randomized Cross-Over Comparative Study

<div><p>Introduction</p><p>This study was conducted according to GCP criteria as a prospective randomized cross-over study. The primary goal of the study was to determine clinical findings and patient satisfaction with postoperative treatment. 29 patients with a distal radius fracture that was surgically stabilized from volar and who met the inclusion criteria were enrolled over a 12-month period. Each patient randomly received either a dorsal plaster splint or a vacuum-fit flexible but blocked orthosis applied postoperatively in the operating theatre to achieve postoperative immobilization. After one week all patients were crossed over to the complementary device maintaining the immobilization until end of week 2. After week 2 both groups were allowed to exercise wrist mobility with a physiotherapist, in the orthosis group the device was deblocked, thus allowing limited wrist mobility. After week 4 the devices were removed in both groups. Follow-up exams were performed after postoperative weeks 1, 2, 4 and 12.</p><p>Results and Discussion</p><p>Results were determined after week 1 and 2 using SF 36 and a personally compiled questionnaire; after weeks 4 and 12 with a clinical check-up, calculation of ROM and the DASH Score. Comparison of the two groups showed a significant difference in ROM for volar flexion after 4 weeks, but no significant differences in DASH Score, duration of disability or x-ray findings. With regard to satisfaction with comfort and hygiene, patients were significantly more satisfied with the dynamic orthosis, and 23 of the 29 patients would prefer the flexible vacuum orthosis in future.</p><p>Trial Registration</p><p>German Clinical Trials Register (DRKS) <a href="https://drks-neu.uniklinik-freiburg.de/drks_web/" target="_blank">DRKS00006097</a></p></div

Mean and standarddeviation of the 8 SC-36 Scales.

<p>SF-36 Measurement Model: Physical Health: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), and General Health (GH); Mental Health: Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). Scales of our sample were standardized on German normative postoperativ evaluation [<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0117720#pone.0117720.ref021" target="_blank">21</a>]. The normative German postoperative evaluation has mean 50 and standarddeviation 10.</p

Example of AO 23 C2 fracture lateral and ap (anterior-posterior) view preoperative and 15 weeks postoperative x-rays stabilized with Königsee locking plate.

<p>Example of AO 23 C2 fracture lateral and ap (anterior-posterior) view preoperative and 15 weeks postoperative x-rays stabilized with Königsee locking plate.</p

CONSORT 2010 Flow Diagram.

<p>CONSORT 2010 Flow Diagram.</p

VacoHand Orthosis deblocked in palmar flexion.

<p>VacoHand Orthosis deblocked in palmar flexion.</p

Example of AO 23 A3 fracture lateral and ap view preoperative and 14 weeks postoperative stabilized with Depuy/Synthes locking plate.

<p>Example of AO 23 A3 fracture lateral and ap view preoperative and 14 weeks postoperative stabilized with Depuy/Synthes locking plate.</p

Demographic Data.

<p>15 patients were randomly allocated to group A (first week with orthosis, <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0117720#pone.0117720.g004" target="_blank">Fig. 4</a>) 10 of these being female and 5 male with a mean age 50,93 SD ±15,18 years.</p><p>14 patients were randomly allocated to group B (first week with dorsal forearm plaster splint, <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0117720#pone.0117720.g007" target="_blank">Fig. 7</a>), 11 of these were females and 3 male with a mean age 45,43 SD ±16,61 years.</p><p>Demographic Data.</p

Mean and standard deviation of dorsal extension at time-point 3 and time-point 4 postoperative.

<p>Mean and standard deviation of dorsal extension at time-point 3 and time-point 4 postoperative.</p

DASH Score at time-point 3 and time-point 4.

<p>DASH Score at time-point 3 and time-point 4.</p

Mean and standard deviation of palmar flexion at time-point 3 and time-point 4 postoperative.

<p>Mean and standard deviation of palmar flexion at time-point 3 and time-point 4 postoperative.</p