Anterior Cervical Discectomy and Fusion Performed Using a CaO-SiO2-P2O5-B2O3 Bioactive Glass Ceramic or Polyetheretherketone Cage Filled with Hydroxyapatite/β-Tricalcium Phosphate: A Prospective Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Participants
2.2. Randomization and Follow-Ups
2.3. Interventions: Anterior Cervical Discectomy and Fusion
2.4. Outcomes and Measurements
2.5. Statistical Analysis
3. Results
3.1. Participant Characteristics
3.2. Primary Outcome at 12-Month Follow-Up
3.3. Secondary Outcomes and Adverse Events
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristic | Control Group (n = 40) | Study Group (n = 36) |
---|---|---|
Age (years) | 55.0 ± 11.3 | 54.4 ± 10.6 |
Male/Female * | 27/13 | 25/11 |
BMI (kg/m2) | 24.7 ± 2.3 | 24.4 ± 2.3 |
CCI score | 1.7 ± 1.6 | 1.6 ± 1.5 |
ASA score | 1.5 ± 0.6 | 1.4 ± 0.5 |
Smoking status, n (%) * | ||
Non/Ex-smoker | 21 (52%) | 19 (53%) |
Current smoker | 19 (48%) | 17 (47%) |
Alcohol consumption, n (%) * | ||
None | 10 (25%) | 12 (33%) |
≥1 drink/month | 30 (75%) | 24 (67%) |
VAS for neck pain | 2.8 ± 2.9 | 3.0 ± 2.9 |
VAS for arm pain | 4.6 ± 2.7 | 4.9 ± 2.3 |
NDI | 21.0 ± 22.8 | 25.1 ± 21.9 |
EQ-5D | 0.649 ± 0.189 | 0.695 ± 0.139 |
SF-12 | ||
PCS | 39.7 ± 9.3 | 38.9 ± 8.7 |
MCS | 45.0 ± 12.1 | 43.9 ± 12.3 |
Diagnosis, n (%) * | ||
Myelopathy | 22 (55%) | 17 (47%) |
Radiculopathy | 17 (43%) | 17 (47%) |
Myeloradiculopathy | 1 (2%) | 2 (6%) |
Approach side, n (%) * | ||
Right | 22 (55%) | 19 (53%) |
Left | 18 (45%) | 17 (47%) |
Operation level, n (%) * | ||
C3-4 | 5 (10%) | 4 (9%) |
C4-5 | 10 (20%) | 9 (19%) |
C5-6 | 20 (40%) | 19 (40%) |
C6-7 | 12 (24%) | 12 (26%) |
C7-T1 | 4 (6%) | 3 (6%) |
Group C | Group N | p-Value * | Risk Difference (95% CI) | |
---|---|---|---|---|
Fusion rate on CT † | 74.4% | 81.8% | 7.4% (−11.5% to 26.5%) | |
Fusion rate on dynamic radiographs (ISM < 1 mm) ‡ | 73.7% | 78.1% | 0.666 |
Variables | Group C | Group N | Mean Difference (95% CI) | p-Value |
---|---|---|---|---|
VAS neck | ||||
3 months | 1.67 ± 1.51 | 1.85 ± 1.52 | −0.18 (−0.90–0.53) | 0.722 |
6 months | 1.46 ± 1.70 | 1.85 ± 1.68 | −0.39 (−1.18–0.41) | 0.449 |
12 months | 1.33 ± 2.06 | 1.64 ± 2.40 | −0.30 (−1.35–0.74) | 0.554 |
Overall intervention effect * | NA | NA | NA | 0.988 |
VAS upper extremities | ||||
3 months | 3.28 ± 2.69 | 3.48 ± 2.21 | −0.20 (−1.37–0.97) | 0.723 |
6 months | 2.79 ± 2.21 | 3.00 ± 2.11 | −0.21 (−1.23–0.82) | 0.720 |
12 months | 2.64 ± 2.48 | 3.67 ± 2.45 | −1.03 (−2.19–0.14) | 0.073 |
Overall intervention effect * | NA | NA | NA | 0.535 |
NDI | ||||
3 months | 15.26 ± 14.36 | 19.39 ± 14.83 | −4.13 (−11.01–2.74) | 0.307 |
6 months | 12.14 ± 17.92 | 18.90 ± 14.74 | −6.76 (−14.56–1.05) | 0.095 |
12 months | 13.57 ± 13.53 | 15.97 ± 14.11 | −2.40 (−8.91–4.11) | 0.553 |
Overall intervention effect * | NA | NA | NA | 0.782 |
EQ-5D | ||||
3 months | 0.775 ± 0.132 | 0.790 ± 0.093 | −0.014 (−0.069–0.040) | 0.665 |
6 months | 0.793 ± 0.163 | 0.799 ± 0.117 | −0.007 (−0.074–0.061) | 0.842 |
12 months | 0.809 ± 0.140 | 0.801 ± 0.111 | 0.008 (−0.053–0.068) | 0.816 |
Overall intervention effect * | NA | NA | NA | 0.591 |
SF12-PCS | ||||
3 months | 45.16 ± 7.92 | 41.64 ± 10.41 | 3.52 (−0.79–7.83) | 0.089 |
6 months | 47.28 ± 9.29 | 43.28 ± 7.98 | 4.01 (−0.11–8.12) | 0.053 |
12 months | 48.80 ± 7.54 | 46.41 ± 8.47 | 2.38 (−1.38–6.14) | 0.259 |
Overall intervention effect * | NA | NA | NA | 0.444 |
SF12-MCS | ||||
3 months | 51.52 ± 11.71 | 51.89 ± 8.84 | −0.36 (−5.31–4.59) | 0.887 |
6 months | 51.62 ± 44.45 | 50.88 ± 9.45 | 0.74 (−4.23–5.71) | 0.773 |
12 months | 52.32 ± 10.24 | 49.96 ± 9.74 | 2.35 (−2.37–7.08) | 0.357 |
Overall intervention effect * | NA | NA | NA | 0.879 |
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Park, J.; Park, S.-M.; Ham, D.-W.; Hong, J.-Y.; Kim, H.-J.; Yeom, J.S. Anterior Cervical Discectomy and Fusion Performed Using a CaO-SiO2-P2O5-B2O3 Bioactive Glass Ceramic or Polyetheretherketone Cage Filled with Hydroxyapatite/β-Tricalcium Phosphate: A Prospective Randomized Controlled Trial. J. Clin. Med. 2023, 12, 4069. https://doi.org/10.3390/jcm12124069
Park J, Park S-M, Ham D-W, Hong J-Y, Kim H-J, Yeom JS. Anterior Cervical Discectomy and Fusion Performed Using a CaO-SiO2-P2O5-B2O3 Bioactive Glass Ceramic or Polyetheretherketone Cage Filled with Hydroxyapatite/β-Tricalcium Phosphate: A Prospective Randomized Controlled Trial. Journal of Clinical Medicine. 2023; 12(12):4069. https://doi.org/10.3390/jcm12124069
Chicago/Turabian StylePark, Jiwon, Sang-Min Park, Dae-Woong Ham, Jae-Young Hong, Ho-Joong Kim, and Jin S. Yeom. 2023. "Anterior Cervical Discectomy and Fusion Performed Using a CaO-SiO2-P2O5-B2O3 Bioactive Glass Ceramic or Polyetheretherketone Cage Filled with Hydroxyapatite/β-Tricalcium Phosphate: A Prospective Randomized Controlled Trial" Journal of Clinical Medicine 12, no. 12: 4069. https://doi.org/10.3390/jcm12124069