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Early mobilization versus delayed mobilisation following the use of a volar locking plate with non-vascularized bone graft in scaphoid non-union. A multicentred randomised controlled-trial
Muirhead C, Talia A, Fraval A, Ross A, Thai D
Journal of Orthopaedics 2021 Jan;23:203-207
clinical trial
7/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

This randomized clinical trial investigated the potential for early mobilization of the wrist following open reduction and internal fixation (ORIF) with a scaphoid specific volar locking plate and non-vascularized bone graft for scaphoid non-union. 16 patients with scaphoid non-union underwent internal fixation with a scaphoid-specific volar locking plate and iliac crest bone graft and were randomized to one of two treatment arms (A) The control were immobilized in a below elbow cast for 6 weeks (n = 9) and (B) The experimental arm were mobilized early with a removable wrist splint (n = 7). Outcomes were measured preoperatively, and at 3 months post operatively. These included the primary outcome of union, and secondary outcomes of grip strength and patient reported outcomes of disabilities of arm shoulder and hand (DASH) and patient reported wrist evaluation (PRWE). Discrete variables were analyzed using the chi squared test while continuous variables used the students t-test. The experimental (early mobilization) group developed metalware complications resulting in the early termination of the study. No significant difference in the demographic characteristics of age, gender, time to surgery, smoking status and handedness was found between groups. A significant difference was found in BMI, with significantly higher proportion of obese patients (p = 0.05) in the experimental group. There was no significant difference in the primary outcome measure of the rate of union between groups. The secondary outcomes of grip strength, Dash and PRWE also showed no significant difference between the immobilized and mobilized groups. We recommend immobilization following scaphoid non-union ORIF using a volar locking plate due to high complication rates in our cohort with early mobilization. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic 2. Trial registration. Australian New Zealand Clinical Trials Registry (ACTRN12614001050640). Date of registration, 02/10/2014.

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