OBJECTIVES: To evaluate mid-term patient-reported satisfaction and residual symptoms after plate fixation (PF) or nonoperative treatment (NOT) for displaced midshaft clavicular fractures. DESIGN: Follow-up survey of randomized controlled trial. SETTING:Sixteen teaching and nonteaching hospitals. PARTICIPANTS: All 160 patients with a fully displaced, midshaft clavicular fracture who had been randomized were approached by telephone. INTERVENTION: Randomization for open reduction and internal PF or a sling for 2 weeks (NOT). MAIN OUTCOME MEASUREMENTS: Outcomes were satisfaction with the received treatment, with the cosmetic result and with shoulder function (on a scale of 1-10), and presence of residual symptoms. RESULTS: Seventy-nine patients (40 after PF and 39 after NOT) could be contacted. The median follow-up was 53 (34-79) months. Overall satisfaction was similar for PF and NOT (mean ± SD: 7.7 ± 2.1 vs. 6.9 ± 2.4, P = 0.12), as was satisfaction with the shoulder function (8.9 ± 1.6 vs. 8.4 ± 2.0, P = 0.27). Satisfaction with the cosmetic result was higher after PF (8.2 ± 1.6 vs. 6.8 ± 2.0, P = 0.002). Residual symptoms were frequently present in both groups (55% for PF vs. 41% for NOT, P = 0.26). After PF, 88% of patients would prefer the same treatment again compared with 41% after NOT (P < 0.001). CONCLUSIONS: Aspects of satisfaction seem higher after PF. Residual symptoms, however, were common after both treatments for clavicular fractures. The present results can be used to manage patients' expectations and provide objective information regarding both treatment options before a shared treatment decision is made. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
RCT Entities:
OBJECTIVES: To evaluate mid-term patient-reported satisfaction and residual symptoms after plate fixation (PF) or nonoperative treatment (NOT) for displaced midshaft clavicular fractures. DESIGN: Follow-up survey of randomized controlled trial. SETTING: Sixteen teaching and nonteaching hospitals. PARTICIPANTS: All 160 patients with a fully displaced, midshaft clavicular fracture who had been randomized were approached by telephone. INTERVENTION: Randomization for open reduction and internal PF or a sling for 2 weeks (NOT). MAIN OUTCOME MEASUREMENTS: Outcomes were satisfaction with the received treatment, with the cosmetic result and with shoulder function (on a scale of 1-10), and presence of residual symptoms. RESULTS: Seventy-nine patients (40 after PF and 39 after NOT) could be contacted. The median follow-up was 53 (34-79) months. Overall satisfaction was similar for PF and NOT (mean ± SD: 7.7 ± 2.1 vs. 6.9 ± 2.4, P = 0.12), as was satisfaction with the shoulder function (8.9 ± 1.6 vs. 8.4 ± 2.0, P = 0.27). Satisfaction with the cosmetic result was higher after PF (8.2 ± 1.6 vs. 6.8 ± 2.0, P = 0.002). Residual symptoms were frequently present in both groups (55% for PF vs. 41% for NOT, P = 0.26). After PF, 88% of patients would prefer the same treatment again compared with 41% after NOT (P < 0.001). CONCLUSIONS: Aspects of satisfaction seem higher after PF. Residual symptoms, however, were common after both treatments for clavicular fractures. The present results can be used to manage patients' expectations and provide objective information regarding both treatment options before a shared treatment decision is made. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
Authors: Carlo Biz; Davide Scucchiari; Assunta Pozzuoli; Elisa Belluzzi; Nicola Luigi Bragazzi; Antonio Berizzi; Pietro Ruggieri Journal: J Pers Med Date: 2022-05-07