Table 5.
Study Characteristics—Clinical Outcome.
| Author (Year) Study design LoE | Treatment | FU (SD and Range) n/N (% FU) | Clinical Outcomes at Follow-up Mean ± SD; Median (Range) [As Available] | Perioperative Outcomes and Return to Activity | Adverse Events (Complications/Reoperations) |
|---|---|---|---|---|---|
| Wood (2003) RCT II | Operative: Short-segment (2- to 5-level) posterolateral spinal arthrodesis with pedicle screw-hook instrumentation and ICBG or Anterior 2-level fibular and rib-strut construct arthrodesis with local autogenous bone-grafting and instrumentation. | Operative: 42.9 mo (SD: 14.8, range 24-72 mo) 24/26 (92%) | Operative: VAS (0-10): 3.3 (0-7.5) ODI: 20.75 (0-48) RMDQ: 8.16 (0-19) SF-36: Pain 59 Health Perception 69 Physical Function 63 Social Function 84 Role; Physical 51 Role; Emotional 80 Mental Health 81 Energy/Fatigue 84 | Operative: Time to return to regular work: 10 (42%) at 6 mo Plus 4 (17%) between 6 and 24 mo | Operative: 19 complications in 16 patients: Wound dehiscence (2) Instrumentation/bone failure (2) Wound infection (deep) (1) Pseudarthrosis (1) Neurapraxia (1) Ketoacidosis (1) Instrumentation break (2) Urinary tract infection (2) Seroma (1) Instrumentation removal (6) Impairments of neurological function (0) |
| Nonoperative: Body cast with manual kyphosis reduction through anterior force, worn for 8-12 wk, followed by thoracolumbosacral orthosis for 8 weeks or Thoracolumbosacral orthosis with the spine in hyperextension to reduce the kyphosis and subsequent molded plaster cast that was then converted to an encompassing plastic jacket, worn for 24 h/d except for showering for 1216 wk | Nonoperative: 45.8 mo (SD: 21.9, range 24-118 mo) 23/27 (85%) | Nonoperative: VAS (0-10): 1.9 (0-9) ODI: 10.7 (0-52) RMDQ: 3.9 (0-24) SF-36: Pain 72 Health Perception 72 Physical Function 86 Social Function 83 Role; Physical 85 Role; Emotional 79 Mental Health 75 Energy/Fatigue 56 | Nonoperative: Time to return to regular work: 17 (74%) at 6 mo Plus 2 (9%) at 24 mo | Nonoperative: 2 complications in 2 patients: Urinary tract infection (1) Skin blisters (1) | |
| Landi (2014) Retrospective cohort III | Operative: Percutaneous short stabilization: one level above and one below | Operative: 12 mo ND 25/25 (100%) | Operative: RMDQ: 1.4 (0-4) ODI: 14% (4-36%) VAS (0-10): 0 Patient satisfaction/quality of life (1-10): 9.4 | Operative: Blood loss: 10 cm3 OR time: 80 min Time for back to work: 29 days Time to normal activity: 31 days | ND |
| Nonoperative: Rigid brace for 2 mo followed by semirigid brace for another 2 mo | Nonoperative: 12 mo ND 25/25 (100%) | Nonoperative: RMDQ: 3.4 (0-7) ODI: 22% (5%-40%) VAS (0-10): 1.5 patient satisfaction/quality of life (1-10): 8 | Nonoperative: Time for back to work: 117 days Time to normal activity: 87.1 days | ND | |
| Post (2009) Retrospective cohort III | Short fixation (for A3 fractures: called MSPI by other authors) involving 1 or 2 segments (depending on fx type, ie, with 2 damaged endplates: 2 segmental fixation; with 1 damaged endplate: 1-segmental fixation) | Operative: 5. 7y (SD: 2.9, range 2.5-10.6 y) 38/46 (83%) | Operative: RMDQ: 3.3 ± 5.1; 0 (0-17) VAS Spine Score: 82.6 ± 21.9; 94.1 (17-100) | Operative: ND | No further surgery for late onset pain or late onset neurological deficit |
| Bed rest (or rest on a Stryker frame) for 6 weeks, followed by a reclination brace and mobilization. Weightbearing exercises after 3 mo. Brace worn for 9 months (24 h/d in first 6 mo, only during the day in last 3 mo). | Nonoperative: 4.8 y (SD: 2.9, range 2.1-10.4 y) 25/30 (83%) | Nonoperative: RMDQ: 3.1 ± 3.7; 1.0 (0-12) VAS Spine Score: 80.8 ± 19.4; 84.0 (31-100) | Nonoperative: ND | No further surgery for late onset pain or late onset neurological deficit | |
| Shen (2001) Prospective cohort III | Operative: Three-level fixation: Pedicle screws in the level above, in the fractured vertebrae, and in the level below the fractured vertebrae (3 levels, 6 screws). | Operative: 24 mo ND 33/33 (100%) | Operative: VAS (0-10): 1.8±1.3 LBOS: 61±11 Patient satisfaction (1-4) (1 = highest level of satisfaction): 10:18:3:2 | Operative: Blood loss: 350 mL (150-800 mL) Operation time: 142 min (110-180 min) Hospital stay: 10.4 days | Operative: Neurologic deficit, thromboembolism, or decubitus ulcers (0) Superficial infection (1) Broken screws: 3 screws in 2 pts Hardware removal (5): Of these: -prominence and aching pain (3) -hardware breakage (2) Donor site pain (3) |
| Nonoperative: Bed rest with activity allowed (including ambulation) as tolerated by pain with hyperextension brace fitted in slight hyperextension with the patient standing. Brace worn 24 h/d (except when bathing) for 3 months. (according to instructions, but no monitoring of compliance undertaken) | Nonoperative: 24 mo ND 47/50 (94%) | Nonoperative: VAS (0-10): 1.5 ± 1.3 LBOS: 65 ± 10 Patient satisfaction (1-4) (1 = highest level of satisfaction): 18:23:6:0 | Nonoperative: Hospital stay: 9.2 days | Nonoperative: Neurologic deficit, thromboembolism, or decubitus ulcers (0) Late surgery (0) | |
| Wei (2010) RCT Ib | MSPI (monosegmental pedicle instrumentation): Screws inserted into the vertebrae adjacent to the injured endplate (if the broken endplate was the superior and the adjacent vertebra was the upper, or if the broken endplate was the inferior and the adjacent vertebra was the lower). | MSPI: ND (only complete population) No. of pts: ND, assume 47/47 (100%) | MSPI: LBOS: 74.9 ± 8.7 ODI: 34.1 ± 9.7 | MSPI: Blood loss: 157 ± 49 mL (92-275 mL), OR time: 87 ± 24 min (61-123 min) | MSPI: Correction loss of 10°, including 1 screw loosening (3) Screw dislodgement requiring reoperation (1) |
| SSPI (short-segment pedicle instrumentation): Pedicle screws in one level above and one level below the injured vertebra. | SSPI: ND (only complete population) No. of pts: ND, Assume 38/38 (100%) | SSPI: LBOS: 60.2 ± 9.6 ODI: 37.6 ± 11.5 | SSPI: Blood loss: 460 ± 134 mL (240-810 mL). OR time: 138 ± 29 min (93-170 min). | SSPI: Correction loss of 10°, including 1 screw breakage* (2) Screw breakage after trauma not requiring reoperation* (1) *Possibly same patient, wording unclear | |
| Complete population: 27.8 mo (SD: 7.0, range 19-52 mo) ND, assume 95/95 (100%) | Neurological deteriorations after surgery (0) Urinary infection (4) Superficial infection (1) | ||||
| Li (2012) Retrospective cohort III | MSPI (monosegmental pedicle instrumentation): Screws inserted into the vertebrae adjacent to the injured endplate (if the broken endplate was the superior and the adjacent vertebra was the upper, or if the broken endplate was the inferior and the adjacent vertebra was the lower). | MSPI: 13.2 mo (range: 12-26 mo) NA (30/30, retrospective, only pts w/ FU) | MSPI: VAS: 1.4 ± 0.8 | MSPI: Blood loss: 180 ± 62 mL OR time: 90 ± 25 min | MSPI: Wound seroma (1) |
| SSPI (short-segment pedicle instrumentation): Pedicle screws in one level above and one level below the injured vertebra. | SSPI: 34.6 mo (range 12-64 mo) NA (30/30, retrospective, only pts w/ FU) | SSPI VAS: 1.1 ± 0.6 | SSPI: Blood loss: 203 ± 88 mL. OR time: 101 ± 28 min | SSPI: Screw removal due to breakage (1) Adjacent segment degeneration (1) | |
| Bailey (2014) RCT Ib | No orthosis (NO): Immediate mobilization as tolerated with restrictions to limit bending and rotating through the trunk. Return to normal activities encouraged after 8 wk. | NO: 24 mo: ND 36/49 (73%) 12 mo: 40/49 (82%) | NO at 24 mo: RMDQ: 4.44 ± 5.53(0-23) VAS: 2.03 ± 2.04 (0-7) NO at 12 mo: RMDQ: 5.33 ± 5.81 (0-17) VAS: 2.22 ± 1.89 (0-7) figures by personal communication | NO: Hospital stay (mean ± SD) 2.6 ± 2.7 days | NO: Surgical interventions (2) (A) Surgery before initial hospital discharge: - due to severe radicular pain not present when supine (1) - due to severe mechanical back pain necessitating surgical stabilization (1) |
| Early mobilization with “off-the-shelf” adjustable thoracolumbosacral orthosis (TLSO): Strict bed rest until fitted with a TLSO and mobilization in the brace. The TLSO worn at all times except when lying flat in bed for a total of 10 wk with start of weaning from the brace at 8 wk. | TLSO: 24 mo: ND 32/47 (68%) 12 mo: ND 41/47 (87%) | TLSO at 24 mo: RMDQ: 3.03 ± 4.8 (0-24) VAS: 1.58 ± 1.87 (0-8) TLSO at 12 mo: RMDQ: 3.2 ± 4.65 (0-14) VAS: 1.58 ± 1.87 (0-8) figures by personal communication | TLSO: Hospital stay (mean ± SD) 2.5 ± 2.9 days | TLSO: Surgical interventions (4) (A) Surgery before initial hospital discharge: - due to severe radicular pain not present when supine (1) - due to severe mechanical back pain necessitating surgical stabilization (2) (B) Surgery after initial hospital discharge: - osteotomy 8 months after fracture (1) | |
| Proietti (2014) Retrospective cohort III | All patients (group A* + group B**): Short stabilization: one level above and one below *Group A: SI > 10° ≤ 15° **Group B: SI > 15° | Total population (group A + group B) Minimum 12 mo (range12-48 mo) 60/63 (95%) | Group A: VAS: 1.8 (range 0.5-2.5) ODI: 12% (range 5%-17%) SF36 PCS: 83.2% (range 67.5%-95.4%) SF36 MCS: 79.9% (range 63.2%-83.5%) | Total population (group A + group B) Blood loss: 82 mL (50-96 mL) OR time: 67 min (50-96 min) Hospital stay: 4.9 days (3-7 days) | Total population (group A + group B) Superficial dehiscence at 6 wk: (1) Implant removal due to deep infection at 1 mo (1) Hardware failure at 5 years (1) |
| Group B: VAS: 4.25 (range 1.4-6.2) ODI: 38% (range 17%-45%) SF36 PCS: 73.5% (range 57.6%-85.3%) SF36 MCS: 68.8% (range 53.2%-75.6%) | |||||
| Schmid (2011) Prospective cohort III | Short segmental posterior fixation with angular stable pedicle screw systems Plus posterolateral fusion Plus unilateral TLIF with monocortical strut grafts and cancellous bone (ICBG) implant removal at a mean of 15.1 ± 3.7 mo Analysis performed separately for two patient groups, but only one (“TLIF group”) was large enough to be eligible for this review, so the other group is not mentioned here | 20.2 mo (SD: 6.1 mo) 21/21 (100%) | RMDQ: 4.4 ± 4.4 ODI: 14.4 ± 12.4 FFbH-R: 82.3 ± 19.3 VAS score: 73.0 ± 21.3 MPQ: 13.9 ± 18.4 | Mean surgery time: 176 ± 72 min Mean blood loss: 1000 ± 1280 mL Length of hospital stay: 11.8 ± 5.2 days Duration of work incapacity: 4.9 ± 5.1 mo | Posterior approach–related complaints No complaints (15) Mild complaints (5) Severe complaints (1) Anterior approach related complaints No complaints (21) Mild complaints (0) Severe complaints (0) Donor-site related complaints No complaints (15) Mild complaints (4) Severe complaints (2) |
| Jeong (2013) Retrospective cohort III | Pedicle screws 1 level above and 1 level below the fracture level | 27.6 mo (range 12-66 mo) NA (23/23, retrospective, only pts w/ FU) | VAS: 4.6 (3-6) ODI: 19.6 (6-27) | ND | Metal failure* (4) Posttraumatic kyphosis (5) Adjacent spine disease (6) *Pedicle screw pull-out or breakage |
| Koller (2008) Retrospective case series IV | Manual kyphosis reduction through anterior force, then 3 months of brace (24 h/d) | 112.8 mo (SD:47 mo) NA (21/21, retrospective, only pts w/ FU) | Mean ± SD RMDQ: 3.2 ± 5.0 LBOS: 49.5 ± 17.6 VAS Spine Score: 74 ± 15 SF-36 PCS: 47.1 ± 9.3 SF-36 MCS:49.4 ± 10.3 Median (25%-75% quartile) RMDQ: 1 (0-3) LBOS: 54 (41-62) VAS Spine Score: 75 (64-84) SF-36 PCS: 48.3 (43.9-54.1) SF-36 MCS: 53.3 (44.7-57) | ND | Pulmonary artery embolism during immobilization in cast (1) Symptomatic lumbar posttraumatic kyphotic deformity following burst fracture of L4 (1) |
| Andress (2002) Retrospective case series IV | Internal fixator either with or without transpedicular spongiosa grafting with fixed-angle pedicle screw instrumentation and pedicle screws above and below the fractured vertebral body In cases where the kyphotic angle was large or where the fractured vertebral body was completely destroyed: transpedicular inter- and intracorporal autologous bone grafting after transpedicular discectomy transpedicular spongiosa grafting: 29 pts (58%) not grafting: 21 pts (42%) | 68 mo (range 36-103 mo) NA (50/50, retrospective, only pts w/ FU) | Activity score (1-7): 4.92 points FFbH-R: 81.7 ± 14.4 points With bone graft or without: (mean ± SD) FFbH-R for pts w/ bone graft: 82.4±14.2 FFbH-R for pts w/o bone graft: 80.7±15.1 FFbH-R stratified according to fx type (mean ± SD) A 3.1: 81.1 ± 16.4 A 3.2: 80.6 ± 15.4 A 3.3: 84.3 ± 9.5 | ND | Harvest site pain in 2/29 (6.9%) |
Abbreviations: ND, not documented; w/, with; w/o, without; pt, patient; pts: patients, NA, not applicable; fx, fracture; SI, Sagittal Index; RMDQ, Roland Morris Disability Questionnaire25; VAS (0-10), visual analogue scale for pain; VAS spine score: VAS spine score42; LBOS, Low Back Outcome Score26; ODI, Oswestry Disability Index40; FFbH-R, Hannover Spine Score43; MPQ, McGill Pain Questionnaire44; SF-36 PCS: Short Form–36 Physical Health Summary Scale41; SF-36 MCS: Short Form–36 Mental Health Summary Scale.41