Abstract
BACKGROUND: The clinical consequences of routine follow-up radiographs for patients with ankle fracture are unclear, and their usefulness is disputed. The purpose of the present study was to determine if routine radiographs made at weeks 6 and 12 can be omitted without compromising clinical outcomes.
METHODS: This multicenter randomized controlled trial with a noninferiority design included 246 patients with an ankle fracture, 153 (62%) of whom received operative treatment. At 6 and 12 weeks of follow-up, patients in the routine-care group (n = 128) received routine radiographs whereas patients in the reduced-imaging group (n = 118) did not. The primary outcome was the Olerud-Molander Ankle Score (OMAS). Secondary outcomes were the American Academy of Orthopaedic Surgeons (AAOS) foot and ankle questionnaire, health-related quality of life (HRQoL) as measured with the EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) and Short Form-36 (SF-36), complications, pain, health perception, self-perceived recovery, the number of radiographs, and the indications for radiographs to be made. The outcomes were assessed at baseline and at 6, 12, 26, and 52 weeks of follow-up. Data were analyzed with use of mixed models.
RESULTS: Reduced imaging was noninferior compared with routine care in terms of OMAS scores (difference [β], -0.9; 95% confidence interval [CI], -6.2 to 4.4). AAOS scores, HRQoL, pain, health perception, and self-perceived recovery did not differ between groups. Patients in the reduced-imaging group received a median of 4 radiographs, whereas those in the routine-care group received a median of 5 radiographs (p < 0.05). The rates of complications were similar (27.1% [32 of 118] in the reduced-imaging group, compared with 22.7% [29 of 128] in the routine-care group, p = 0.42). The types of complications were also similar.
CONCLUSIONS: Implementation of a reduced-imaging protocol following an ankle fracture has no measurable negative effects on functional outcome, pain, and complication rates during the first year of follow-up. The number of follow-up radiographs can be reduced by implementing this protocol.
LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Original language | English |
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Pages (from-to) | 1588-1599 |
Number of pages | 12 |
Journal | Journal of Bone and Joint Surgery. American Volume |
Volume | 102 |
Issue number | 18 |
Early online date | 25 Jun 2020 |
DOIs | |
Publication status | Published - 16 Sept 2020 |
Funding
Disclosure: This study was funded by ZonMw, the Netherlands Organization for Health Research and Development (project number 837002403). The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (http://links.lww.com/JBJS/F989).
Funders | Funder number |
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ZonMw | 837002403 |