Article Figures & Data
Figures
- Fig 1.
Patient accountability.
- Fig 2.
Distribution of index and prevalent fractures and those with edema and vacuum cleft for the BKP and VP groups combined. Index levels (those identified as treatment levels) and prevalent fractures (all radiographic fractures assessed by the core laboratory) are shown, identified from standing lateral x-ray films with 379 of 381 treated patients contributing data. The distribution of levels with edema and those with vacuum cleft is shown on the basis of available MR imaging at baseline (294 of 381 treated patients).
- Fig 3.
Kaplan-Meier survival analysis for new clinical fractures.
- Fig 4.
Quality-of-life, disability, and pain assessments at baseline and after balloon kyphoplasty or vertebroplasty. Means and 95% confidence intervals are shown for balloon kyphoplasty (solid lines) and vertebroplasty (dashed lines) for the SF-36 Physical Component Summary (scale 0–100) (A); the total EQ-5D scores (scale 0–1) (B); back pain (scale 0–10) (C); and the Oswestry Disability Index (scale 0–100) (D). The treatment P value in each panel indicates the comparison between groups. Below each panel, the n for each group is shown for baseline, 3, 12, and 24 months and the group average for change from baseline and 95% CI for 3, 12, and 24 months. The asterisk indicates P < .001 for all change from baseline scores.
- Fig 5.
Cement extravasation. The percentage of treated vertebrae in each treatment group having cement extravasation, measured by using postoperative CT, is shown; results are based on evaluable CT data for 168/191 patients with BKP and 160/190 with VP, accounting for 214/244 and 201/233 levels, respectively. Fischer exact P values comparing the 2 treatment groups for each category are shown.
Tables
Kyphoplasty (n = 191) Vertebroplasty (n = 190) P Value Surgery as randomized (No.) 191 190 Physician type (m) (%) .019 Interventional radiologist 117 (61.3) 138 (72.6) Interventional neuroradiologist 33 (17.3) 27 (14.2) Orthopedic surgeon 41 (21.5) 23 (12.1) Neurosurgeon 0 2 (1.1) Anesthesia (m) (%) .086 Local with conscious sedation 125 (65.4) 143 (75.3) General 55 (28.8) 37 (19.5) Other 11 (5.8) 10 (5.3) Hospitalization (m) (%) .014 Outpatient 109 (57.1) 132 (69.5) Inpatient 82 (42.9) 58 (30.5) Postural reduction performed (m) (%) 154 (80.6) 142 (75.1) .217 Procedure duration (min) (mean) (SD) 40.0 (22.0) 31.8 (19.3) <.001 Fluoroscopy duration (min) (mean) (SD) 10.0 (6.3) 8.5 (4.9) .008 Duration of stay (hr) (median) (IQR) 22.0 (6.0–26.0) 8.0 (5.0–24.0) .010 Fractures treated n = 244 n = 235 Procedure (m) (%) <.001 Bilateral 242 (99.2) 151 (65.1) Unilateral 2 (0.8) 81 (34.9) Total cement volume (mL) (median) (IQR)a 4.6 (3.4–6.0) 4.0 (3.0–6.0) .053 Fractures scanned by CTb n = 214 n = 201 Vertebral body volume (mL) (median) (IQR) 25.7 (19.3–31.4) 25.1 (19.4–31.9) .74 Cement volume (mL) (median) (IQR) 5.2 (3.8–6.3) 4.6 (2.9–6.5) .037 Cement/vertebral ratio (median) (IQR) 0.21 (0.16–0.26) 0.19 (0.13–0.25) .008 Note:—(m) indicates numerator (No.) in category; IQR, interquartile range.
↵a For BKP, all patients were treated with HV-R bone cement (Kyphon; Medtronic Spine, Sunnyvale, California). For VP, 46 (24.3%) patients were treated with Spineplex (Stryker, Kalamazoo, Michigan); 43 (22.8%), with Parallax (ArthroCare, Austin, Texas); 34 (18.0%), with AVAtex (CareFusion, San Diego, California); 14 (7.4%), with Confidence (DePuy Spine, Raynham, Massachusetts); 11 (5.8%), with HV-R (Kyphon); 10 (5.3%), with Visioplast (Tecres, Verona, Italy); and 10 (5.3%), with Vertefix (Cook, Bloomington, Indiana). The remaining 21 (11.1%) were treated with other bone cements.
↵b CT assessments were made by the core radiographic laboratory.
Levels (No.) Raw Data Change from Baseline in Degrees (Mean) (95% CI)a ANCOVA Change from Baseline in Degrees (LS Mean) (95% CI) ANCOVA Estimate of Mean Difference (95% CI) ANCOVA P Value BKP VP BKP VP BKP VP Post-op 213 195 3.10 (2.39–3.80) 3.41 (2.61–4.21) 3.34 (2.70–3.99) 3.14 (2.47–3.81) 0.21 (−0.73–1.14) .663 3 Mo 168 155 1.78 (0.98–2.58) 2.28 (1.37–3.19) 2.00 (1.27–2.72) 2.04 (1.28–2.80) −0.04 (−1.10–1.01) .933 12 Mo 154 127 1.97 (1.11–2.82) 1.51 (0.58–2.44) 2.18 (1.47–2.89) 1.26 (0.48–2.04) 0.92 (−0.14–1.98) .089 24 Mo 99 92 2.09 (0.90–3.28) 1.43 (0.39–2.47) 2.46 (1.55–3.37) 1.04 (0.09–1.98) 1.42 (0.10–2.74) .036 Note:—Post-op indicates postoperative; LS, least squares.
↵a On the basis of the paired t test, changes from baseline results at each time point within each group (BKP and VP) were statistically significant (P ≤ .007).
No. of Patientsa Kyphoplasty (n = 191) Vertebroplasty (n = 190) With procedure/device/anesthesia-related (or possibly) AEs 12 11 Blood and lymphatic disorders Bone marrow edema 0 1b Gastrointestinal disorders Constipation 1c 0 Immune system disorders Hypersensitivity 0 1c Injury or procedural complications Cement embolism 1d 1d Implant site extravasation 0 1e Mental status changes postoperative 0 1c Procedural hypotension 1c 0 Procedural nausea/vomiting 1c 0 Procedural pain 3f 3f Spinal fracture 1g 0 Musculoskeletal disorders Arthralgia 1g 0 Back pain 2g 3g Muscle spasm 1g 0 Symptomatic vertebral fracture 1g 2g Psychiatric disorders Hallucination 1c 0 Respiratory disorders COPD 1c 0 Hypoxia 0 1c Respiratory failure 0 1c Vascular disorders Hematoma 0 1h Note:—COPD indicates chronic obstructive pulmonary disease.
↵a Patients may have had multiple AEs; all system organ class categories are listed when there was an event considered related (or possibly related) to device/procedure/anesthesia.
↵b In 1 patient, 1 event was considered nonserious and possibly related to bone cement.
↵c In 1 patient, 1 event was considered serious and related (or possibly related) to anesthesia and was resolved with medical intervention.
↵d In 1 patient, 1 event each was considered serious and bone cement–related (or possibly related). In each case, the event occurred after the surgical treatment of a subsequent fracture; the BKP event was resolved with oxygen, and the VP event was ongoing at final follow-up.
↵e In 1 patient, 1 event was considered bone cement–related and nonserious. A spinal canal leak was detected intraoperatively; CT was immediately performed without significant canal stenosis observed with no medical intervention given.
↵f Three patients in each group with 3 (2 serious) and 4 (all serious) events in the BKP and VP groups, respectively, were considered device-related (or possibly related) but were resolved.
↵g The number of patients reflected in the Table had events that were considered serious and related (or possibly related) to the device.
↵h In 1 patient, 1 event was nonserious and possibly related to the procedure (likely a prone position on the operating table).
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