S Carbone1,2, C Razzano3,4,5, P Albino6, R Mezzoprete7. 1. Orthopaedic and Traumatology Department, Ospedale San Camillo de Lellis, Rieti, Italy. stefcarbone@yahoo.it. 2. FIMAC Onlus, Via Giulio Pittarelli 114, 00166, Rome, Italy. stefcarbone@yahoo.it. 3. Department of Physical Medicine and Rehabilitation, Sapienza University of Rome, P.le Aldo Moro, 5, 00185, Rome, Italy. 4. Department of Physical Medicine and Rehabilitation, Centro Medico Erre, Via Pennino Traversa Mustilli, Sant'Agata dei Goti, BN, Italy. 5. MED.IT.A Onlus, Naples, Italy. 6. Casa di Cura Città di Aprilia, Aprilia, Italy. 7. Orthopaedic and Traumatology Department, Ospedale San Camillo de Lellis, Rieti, Italy.
Abstract
PURPOSE: To select in a 2-year survey of proximal humerus fractures accessing the emergency department, a population of osteoporotic stable impacted fractures and to randomize them into two groups, one with an immediate intensive mobilization program and the other with an immediate conventional mobilization program. METHODS: In emergency department, patients with clinical signs of shoulder girdle fracture were submitted to standard X-ray examination and CT scan. Patients with stable (absence of metaphyseal comminution or fifth fragment) osteoporotic (cortical bone thickness lower than 6 mm) impacted (Is any part of metaphysis or head impacted into the shaft? YES/NO) proximal humerus fractures were selected for randomization in one of the two groups. Group 1: early intensive mobilization; Group 2: early conventional mobilization. Functional and radiographic assessment was recorded at 3, 6 and 12 months of follow-up. RESULTS: In the considered period, 120 patients were affected by a stable impacted osteoporotic proximal humerus fracture. At the final follow-up, 36 patients in group 1 and 39 patients in group 2 were available for statistical analysis. Functional and radiographic scores were comparable, with a trend of significance in favor of group 2. No fracture in any of the group showed significant loss of reduction respect to 6 months of follow-up. 4 (10%) and 1 (2.5%) patients in groups 1 and 2 were not compliant with the rehabilitation program (p = 0.037). CONCLUSIONS: This randomized controlled trial showed that impacted osteoporotic proximal humerus fractures can be managed non-operatively with an early conventional rehabilitation program composed by 10 sessions of passive motion twice a week, followed by recovery of active range of motion for further 10 sessions thrice a week, while no advantage is given by a more aggressive rehabilitation regimen. Self-assisted exercises should be explained to patients to maximize the effects of the assisted program. LEVEL OF EVIDENCE: Level 1, randomized controlled double-blinded trial.
RCT Entities:
PURPOSE: To select in a 2-year survey of proximal humerus fractures accessing the emergency department, a population of osteoporotic stable impacted fractures and to randomize them into two groups, one with an immediate intensive mobilization program and the other with an immediate conventional mobilization program. METHODS: In emergency department, patients with clinical signs of shoulder girdle fracture were submitted to standard X-ray examination and CT scan. Patients with stable (absence of metaphyseal comminution or fifth fragment) osteoporotic (cortical bone thickness lower than 6 mm) impacted (Is any part of metaphysis or head impacted into the shaft? YES/NO) proximal humerus fractures were selected for randomization in one of the two groups. Group 1: early intensive mobilization; Group 2: early conventional mobilization. Functional and radiographic assessment was recorded at 3, 6 and 12 months of follow-up. RESULTS: In the considered period, 120 patients were affected by a stable impacted osteoporotic proximal humerus fracture. At the final follow-up, 36 patients in group 1 and 39 patients in group 2 were available for statistical analysis. Functional and radiographic scores were comparable, with a trend of significance in favor of group 2. No fracture in any of the group showed significant loss of reduction respect to 6 months of follow-up. 4 (10%) and 1 (2.5%) patients in groups 1 and 2 were not compliant with the rehabilitation program (p = 0.037). CONCLUSIONS: This randomized controlled trial showed that impacted osteoporotic proximal humerus fractures can be managed non-operatively with an early conventional rehabilitation program composed by 10 sessions of passive motion twice a week, followed by recovery of active range of motion for further 10 sessions thrice a week, while no advantage is given by a more aggressive rehabilitation regimen. Self-assisted exercises should be explained to patients to maximize the effects of the assisted program. LEVEL OF EVIDENCE: Level 1, randomized controlled double-blinded trial.
Authors: M M Lefevre-Colau; A Babinet; F Fayad; J Fermanian; P Anract; A Roren; J Kansao; M Revel; S Poiraudeau Journal: J Bone Joint Surg Am Date: 2007-12 Impact factor: 5.284