NCT01113411.
| Methods | Randomised clinical trial |
| Participants | 80 participants aged over 18 years treated by PHILOS locked plate system for unstable closed fracture of the proximal humerus (2‐part and 3‐part fractures according to the Neer classification) within 7 days on injury. |
| Interventions | 1. Early and intensive exercise programme
"A thoraco brachial brace will be worn for 48 hours following the surgery and then removed for the remainder of treatment. Patients will then start the intensive rehabilitation programme without physical therapy. The exercise programme will be provided to the patient. The exercises consist of active and active‐assisted movements of the shoulder for a period of six weeks, limiting external rotation to 0°. Patients are encouraged to use their affected limb for daily activities. Strengthening exercises are started the 6th week following surgery and the full programme will be completed three months after surgery. Patients who wish can then continue their rehabilitation with a physiotherapist. The patient will complete a daily diary to validate the frequency and intensity of the exercises." 2. Standard rehabilitation programme "The patient will wear the thoraco brachial brace for a period of four weeks following the surgery. It may be taken off for hygiene purposes and dressing. After the four weeks, the patient will take the brace off permanently and begin an exercise programme, writing down the frequency and intensity of the exercises. Physiotherapy is allowed for the remaining part of the three months rehabilitation programme." |
| Outcomes | Length of follow‐up: 12 months Primary outcome: Constant score (adjusted for age) at 6 months. A difference of 10 points is considered significant (standard deviation of 15 points). Secondary outcomes: reoperation, redisplacement, Constant score at 12 months, DASH, return to professional activities, pain, range of motion |
| Notes | Entry for trial (clinicaltrials.gov) on 19 January 2015, indicated that the "recruitment status of this study is unknown because the information has not been verified recently". Status as "recruiting" had been last verified on December 2012. The study completion date had been changed from December 2012 to December 2013. The start date was December 2009. Email enquiring status sent to PI, Dr Stéphane Pelet, Hopital de l'Enfant‐Jésus, Canada (stephane.pelet.ortho@gmail.com) on 16 July 2020. |