Table 2.
Characteristics of trials
| Characteristic | Siebenga et al. [45] | Wood et al. [51] | Shen et al. [43] | Hitchon et al. [26] |
|---|---|---|---|---|
| Study design | Multicenter prospective randomized control trial | Multicenter prospective randomized control trial | Pseudorandomized controlled clinical trial | Prospective controlled clinical trial |
| Size | 34 patients | 53 patients | 83 patients | 31 |
| Location | Netherlands | Minnesota, MN, USA | Kaohsiung, Taiwan | Iowa University, Iowa City, IA, USA, & VA Medical Centers |
| Inclusion criteria | Traumatic fracture of T10-L4 | Isolated thoracolumbar burst fracture; CT scan revealing a burst-type fracture with retropulsion of vertebral body bone into the canal; no new neurologic abnormality; < 3 weeks after injury; age 18–66 years; no medical comorbidities precluding surgery; no ongoing cancer, infection, bleeding disorder, or skin disease | Neurologically intact; single-level closed burst fracture T11-L2; no dislocations, with pedicles and facet joints appearing intact, although the pedicles may have fractured from the vertebral body; age 18 to 65 years; no major organ or musculoskeletal injuries | Nonoperative treatment: angular deformity < 10°; residual spinal canal as measured on CT > 50%; anterior body height > 50% of the posterior height |
| AO Type A; no neurologic deficit; age 18 to 60 years; period between trauma and operative treatment < 10 days. | ||||
| Operative treatment: angular deformity generally measured > 10°; residual spinal canal > 50% of normal | ||||
| Baseline characteristics | ||||
| Operative | ||||
| Age (years) | 45.7 (mean) | 43.3 (mean) | 42 (median) | – |
| Gender M:F | 10:7 | 16:8 | 18:15 | – |
| Mechanism of injury | MVA = 18% (3/17); fall = 53% (9/17); sports = 18% (3/17); industrial = 12% (2/17) | MVA = 50% (12/24); fall = 21% (5/24); industrial = 25% (6/24); recreation = 4% (1/24) | MVA or fall = 98% (78/80) | – |
| Site | T1 = 12% (2/17) | T11 = 4% (1/24) | T12 = 30% (10/33) | |
| L1 = 65% (11/17) | T12 = 17% (4/24) | L1 = 42% (14/33) | ||
| L2 = 6% (1/17) | L1 = 54% (13/24) | L2 = 27% (9/33) | – | |
| L3 = 12% (2/17) | L2 = 25% (6/24) | |||
| L4 = 6% (1/17) | ||||
| Nonoperative | ||||
| Age (years) | 37.3 (mean) | 39.4 (mean) | 44 (median) | – |
| Gender M:F | 10:5 | 16:7 | 23:24 | – |
| Mechanism of injury | MVA = 33% (5/15); fall = 67% (10/15) | MVA = 35% (8/23); fall = 48% (11/23); recreational trauma = 13% (3/23); sports injury = 4% (1/23) | MVA or fall = 98% (78/80) | – |
| Site | T12 = 40% (6/15) | T12 = 17% (4/23) | T11 = 2% (1/47) | |
| L1 = 47% (7/15) | L1 = 65% (15/23) | T12 = 23% (11/47) | ||
| L2 = 7% (1/15) | L2 = 17% (4/23) | L1 = 49% (23/47) | – | |
| L3 = 7% (1/15) | L2 = 26% (12/47) | |||
| Outcomes | VAS pain; RMDQ-24; VAS spine; return to work; kyphosis; complications; and length of stay | VAS pain; RMDQ; Oswestry back pain questionnaire; Short form-36; return to work; kyphosis; percentage of canal compromise; complications; length of hospital stay; and cost of treatment | VAS pain; Greenough Low Back Outcome Score; patient satisfaction; return to work; kyphosis; percentage of canal compromise; complications; hospital cost; and length of hospital stay | Cost |
| Review authors’ judgments about each methodologic quality | ||||
| Adequate sequence generation | Unclear | Yes | No | No |
| Allocation concealment | Unclear | Unclear | Unclear | Unclear |
| Blinding | Unclear | Unclear | Unclear | Unclear |
| Free of other bias | No | No | No | No |
| Completeness of outcome reporting | Incomplete | Incomplete | Incomplete | Incomplete |
| Loss to followup | 6% (2/34) | 11% (6/53) | 4% (3/83) | Unclear |
MVA = motor vehicle accident; VAS = visual analog scale; RMDQ = Roland Morris Disability Questionnaire.