The importance of early rehabilitation in proximal humeral fracture: A clinical trial of efficacy and safety of a new endomedullary nail.

Background: The aim of the surgical treatment in proximal humeral fractures is to maintain bone alignment facilitating an early shoulder mobilization. This can be obtained with the use of an endomedullary nail with specific characteristics: a proximal angular multiplanar stability and the possibility to place proximal screws in the calcar region. The objective of this randomized controlled trial is to investigate the effects of an early rehabilitation program in 3-part proximal humeral fractures treated with endomedullary nailing.

Materials And Methods: 126 patients treated with the Diphos Proximal Humeral Nail (PHN), followed with an Intensive Rehabilitation Program (IRP) started in the second postoperative day, were compared to 62 patients with a Standard Rehabilitation Program (SRP) where shoulder mobilization started after 3 weeks. The age of patients was under 65 years. Main Outcome measures were improvement of shoulder function based on Constant Score and quality of life on DASH questionnaire at 1, 3, 6 and 12 months after surgery. Safety outcome was no loss of radiological reduction at any follow-up control.

Results: A difference considered statistically significant (95% confidence interval) was demonstrated by Constant scores at 3 and 6 months and by DASH questionnaire scores at 1 month after surgery between IRP and SRP groups, however without loss of radiological reduction and maintaining the full fracture healing at the same mean period of 1,8 ± 0,7 months.

Discussion: This experience allows to highlight essential features of this new kind of endomedullary humeral nail, by its mechanical properties, in proximal humeral fractures in order to permit an early rehabilitation without creating displaced or consolidation delay.

Level Of Evidence: III, randomized clinical-case-control study.