Cast-OFF 2: One Week Versus 3-5 Weeks of Plaster Cast Immobilization for Non- or Minimally Displaced Distal Radius Fractures-A Stepped Wedge Cluster Randomized Controlled Trial.

OBJECTIVES

Implementation of 1 week of cast immobilization followed by gradually increasing wrist mobilization for non- or minimally displaced distal radius fracture (DRF) and comparison of the functional outcomes and pain scores with the usual care (3-5 weeks of cast immobilization).

DESIGN

A randomized stepped wedge cluster design, prospective cohort.

SETTING

Academic and peripheral hospitals in levels 1, 2, and 3 trauma centers.

PATIENT SELECTION CRITERIA

All patients between 18 and 85 years old with an isolated non- or minimally and nonreduced DRF were eligible for inclusion. Participating hospitals were randomized to transition from usual care (3-5 weeks of cast immobilization) to 1 week of cast immobilization, following the stepped wedge design.

OUTCOME MEASURES AND COMPARISONS

Patient characteristics, secondary dislocation, surgical treatment, visual analog scale, Patient Rated Wrist Evaluation (PRWE), Patient Reported Outcomes Measurement Information System Pain Interference, Pain Catastrophizing Scale 4, and patient satisfaction were compared between control and intervention group at weeks 1, 3-5, 6, months 3, 6, and 12. A difference around 11 points on the PRWE scale was considered clinically significant.

RESULTS

Four hundred two patients were included (control n = 197 vs. intervention n = 205, 267/135, female/male). There were no differences in age (53.7 ± 18.6 vs. 53.3 ± 19.5, P = 0.27), sex (66% vs. 67% female, P = 0.44), dominant hand fractured (44% vs. 53%, P = 0.39), and type of fracture (39% vs. 41% extra-articular, P = 0.44). After 6 weeks, the PRWE score showed no clinically significant differences (-4.5 [confidence interval -12.9 to 4.02], P = 0.30). No significant differences were observed for function, pain scores, and patient satisfaction between groups (all P > 0.05). Furthermore, there was no significant difference in secondary dislocation rate (control 1.5% vs. intervention 1.0%, P = 0.32) and operation rate (control 1.5% vs. 1.5% intervention, P = 0.92).

CONCLUSIONS

This study compared 1 week of cast immobilization followed by gradually increasing wrist mobilization to the usual care of 3-5 weeks for nonreduced DRF. No clinically significant differences in function, pain scores, patient satisfaction, secondary dislocation, and operations were observed. Therefore, 1 week of plaster immobilization can be safely recommended for the non- or minimally displaced and nonreduced DRF treatment.

LEVEL OF EVIDENCE

Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.