NCT01524965.
Study name | The effect of the timing of postoperative mobilisation after locking plate osteosynthesis of fractures of the surgical neck of the humerus |
Methods | Randomised controlled trial Single‐blind (outcomes assessor) |
Participants | 100 participants, 18 years or older, with surgery performed within 10 days of injury for a dislocated (> 1 cm or 35 degrees) AO 11‐A2, ‐A3, ‐B1 or ‐B2 fracture of the surgical neck of the proximal humerus with a possible fracture of the greater tuberosity |
Interventions | 1. Immediate mobilisation after open reduction and PHILOS plate fixation: immediate passive range of motion exercises are begun postoperatively, after 3 weeks, active unloaded mobilisation begins after three weeks and active, loaded use is allowed 6 weeks postoperatively 2. Standard mobilisation after open reduction and PHILOS plate fixation: immediately postoperatively the arm is held in a sling, active mobilisation of healthy joints and pendulum exercises are begun. Passive range of motion exercises of the shoulder are begun 3 weeks postoperatively. Active mobilisation begins after six weeks |
Outcomes | Follow‐up: 3 and 6 weeks, 3, 6, 12 and 24 months Primary outcome: DASH (Disabilities of the Arm, Shoulder and Hand) score Secondary outcomes: Constant score, Simple Shoulder Test (SST), pain at rest and during motion, subjective satisfaction, quality of life using the 15D instrument, complications |
Starting date | May 2011 Estimated completed date: December 2020 (primary date); December 2022 (final date) |
Contact information | Tuomas Lahdeoja, MD Töölö Hospital, Helsinki University Central Hospital Helsinki, Finland, 00029 Email: tuomas.lahdeoja@hus.fi |
Notes | Verified as recruiting participants in October 2014 by Helsinki University Trial registration document updated 3 January 2017 (version 4 with new completion dates) |