G Merolla1, P Bianchi, G Porcellini. 1. Unit of Shoulder and Elbow Surgery, "D. Cervesi" Hospital, L.V Beethowen 46, Code:47841, Cattolica, RN, Italy, giovannimerolla@hotmail.com.
Abstract
PURPOSE: To assess the efficacy, usability and tolerability of a dynamic orthosis compared with a standard plaster splint after the reconstruction of elbow medial or lateral collateral ligaments (MCL, LCL). METHODS:Twenty-six subjects undergoing MCL (n = 23) or LCL (n = 3) reconstruction were randomly assigned to immobilization with an orthosis (n = 13; group A "Innovator X") or with a plaster splint (n = 13; group B "Plaster splint"). Outcome measures were visual analogue scale pain score, mid-arm (MA) circumference, grip strength, Oxford elbow score (OES) and range of motion (ROM). Patients were assessed at baseline and at 2, 6, 12 and 24 weeks. RESULTS:Significant pain reduction was reported by all patients at 6, 12 and 24 weeks (p < 0.05). Mean MA circumference was significantly higher in group A at all time points (all p < 0.05). Mean grip strength was greater in group A on weeks 2 and 6 (p < 0.05), whereas the difference found on weeks 12 and 24 was not significant. The OES and passive ROM values of the two groups were not significantly different at any time point. CONCLUSIONS: The dynamic orthosis and the plaster splint both provided effective and safe elbow immobilization after MCL or LCL reconstruction. The orthosis provided greater pain reduction, faster recovery of muscle trophism and grip strength, and was better tolerated.
RCT Entities:
PURPOSE: To assess the efficacy, usability and tolerability of a dynamic orthosis compared with a standard plaster splint after the reconstruction of elbow medial or lateral collateral ligaments (MCL, LCL). METHODS: Twenty-six subjects undergoing MCL (n = 23) or LCL (n = 3) reconstruction were randomly assigned to immobilization with an orthosis (n = 13; group A "Innovator X") or with a plaster splint (n = 13; group B "Plaster splint"). Outcome measures were visual analogue scale pain score, mid-arm (MA) circumference, grip strength, Oxford elbow score (OES) and range of motion (ROM). Patients were assessed at baseline and at 2, 6, 12 and 24 weeks. RESULTS: Significant pain reduction was reported by all patients at 6, 12 and 24 weeks (p < 0.05). Mean MA circumference was significantly higher in group A at all time points (all p < 0.05). Mean grip strength was greater in group A on weeks 2 and 6 (p < 0.05), whereas the difference found on weeks 12 and 24 was not significant. The OES and passive ROM values of the two groups were not significantly different at any time point. CONCLUSIONS: The dynamic orthosis and the plaster splint both provided effective and safe elbow immobilization after MCL or LCL reconstruction. The orthosis provided greater pain reduction, faster recovery of muscle trophism and grip strength, and was better tolerated.