title: Comparative study of the treatment outcomes of osteoporotic compression fractures without neurologic injury using a rigid brace, a soft brace, and no brace: a prospective randomized controlled non-inferiority trial.
abstract: BACKGROUND
  The efficacy of brace application for the treatment of osteoporotic compression fractures remains unclear. The purpose of this study was to compare the treatment outcomes in patients with osteoporotic compression fractures with regard to whether the patients had no braces, rigid braces, or soft braces.
  
  
  METHODS
  We randomly assigned sixty patients with acute one-level osteoporotic compression fractures within three days of injury to the no-brace, soft-brace, and rigid-brace groups through 1:1:1 allocation. The primary outcome was the baseline adjusted Oswestry Disability Index score at twelve weeks after compression fracture. The non-inferior margin of the Oswestry Disability Index was set at an average of 10 points.
  
  
  RESULTS
  The baseline adjusted Oswestry Disability Index score at twelve weeks after compression fracture in the no-brace group was not inferior to that in the soft-brace or rigid-brace groups. The mean adjusted Oswestry Disability Index score was 35.95 points (95% confidence interval, 25.42 to 46.47 points) in the no-brace group and 37.83 points (95% confidence interval, 26.77 to 48.90 points) in the soft-brace group, with a difference of -1.88 points (95% confidence interval, -7.02 to 9.38 points) between the groups. Similarly, the mean adjusted Oswestry Disability Index score was 35.95 points (95% confidence interval, 25.42 to 46.47 points) in the no-brace group and 33.54 points (95% confidence interval, 23.79 to 43.29 points) in the rigid-brace group, with a difference of 2.41 points (95% confidence interval, -7.86 to 9.27 points) between the groups. During the follow-up assessment period, there was no significant difference among the groups for the overall Oswestry Disability Index scores (p = 0.260), visual analog scale for pain scores for back pain (p = 0.292), and anterior body compression ratios (p = 0.237). However, the Oswestry Disability Index scores and the visual analog scale scores for back pain significantly improved with time after the fractures (p < 0.001), and the body compression ratios significantly decreased with time in all three groups (p < 0.001).
  
  
  CONCLUSIONS
  The Oswestry Disability Index scores for the treatment of compression fractures without a brace were not inferior to those with soft or rigid braces. Moreover, the improvement in back pain and progression of anterior body compression were similar among the three groups.
  
  
  METHODS
  Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
authors.affiliation: Spine Center and Department of Orthopaedic Surgery, Seoul National University College of Medicine and Seoul National University Bundang Hospital, 166 Gumiro, Bundang-gu, Sungnam, 463-707, Republic of Korea. E-mail address for J.S. Yeom: highcervical@gmail.com.
authors.forename: Ho-Joong
authors.initials: HJ
authors.lastname: Kim
authors.affiliation: Department of Orthopaedic Surgery, Kangwon National University Hospital, 156, Chuncheon, Gangwon-do, 200-722, Republic of Korea.
authors.forename: Je-Min
authors.initials: JM
authors.lastname: Yi
authors.affiliation: Spine Center and Department of Orthopaedic Surgery, Seoul National University College of Medicine and Seoul National University Bundang Hospital, 166 Gumiro, Bundang-gu, Sungnam, 463-707, Republic of Korea. E-mail address for J.S. Yeom: highcervical@gmail.com.
authors.forename: Hyeon-Guk
authors.initials: HG
authors.lastname: Cho
authors.affiliation: Department of Orthopaedic Surgery, Seoul National University College of Medicine and Seoul National University Hospital, 101 Daehangno, Jongno-gu, Seoul, 110-744, Republic of Korea.
authors.forename: Bong-Soon
authors.initials: BS
authors.lastname: Chang
authors.affiliation: Department of Orthopaedic Surgery, Seoul National University College of Medicine and Seoul National University Hospital, 101 Daehangno, Jongno-gu, Seoul, 110-744, Republic of Korea.
authors.forename: Choon-Ki
authors.initials: CK
authors.lastname: Lee
authors.affiliation: Department of Orthopedic Surgery, Seoul Sacred Heart General Hospital, 259 Wangsan-ro, Chungryangri-dong, Dongdaemoon-gu, Seoul 130-011, Republic of Korea.
authors.forename: Jee Hyoung
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Spine Center and Department of Orthopaedic Surgery, Seoul National University College of Medicine and Seoul National University Bundang Hospital, 166 Gumiro, Bundang-gu, Sungnam, 463-707, Republic of Korea. E-mail address for J.S. Yeom: highcervical@gmail.com.
authors.forename: Jin S
authors.initials: JS
authors.lastname: Yeom
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001915:Braces; D004185:Disability Evaluation; D005260:Female; D005500:Follow-Up Studies; D005592:Fracture Fixation / Q000295:instrumentation*; D050815:Fractures, Compression / Q000628:therapy*; D006801:Humans; D008159:Lumbar Vertebrae / Q000293:injuries*; D008297:Male; D008875:Middle Aged; D058866:Osteoporotic Fractures / Q000628:therapy*; D011446:Prospective Studies; D016103:Spinal Fractures / Q000628:therapy*; D013904:Thoracic Vertebrae / Q000293:injuries*; D016896:Treatment Outcome