Norio Yamamoto1,2, Takahisa Ogawa3, Masahiro Banno4,5,6, Jun Watanabe4,7,8, Tomoyuki Noda9, Haggai Schermann10, Toshifumi Ozaki11. 1. Department of Orthopedic Surgery, Kagawa Prefectural Central Hospital, 1-2-1, Asahi-machi, Takamatsu, Kagawa, 760-8557, Japan. norio-yamamoto@umin.ac.jp. 2. Systematic Review Workshop Peer Support Group (SRWS-PSG), Osaka, Japan. norio-yamamoto@umin.ac.jp. 3. Department of Orthopedic Surgery, Tokyo Medical and Dental University, Tokyo, Japan. 4. Systematic Review Workshop Peer Support Group (SRWS-PSG), Osaka, Japan. 5. Department of Psychiatry, Seichiryo Hospital, Tsurumai 4-16-27, Showa-ku, Nagoya, 466-0064, Japan. 6. Department of Psychiatry, Nagoya University Graduate School of Medicine, Tsurumai-cho 65, Showa-ku, Nagoya, 466-8560, Japan. 7. Department of Surgery, Tottori Prefectural Central Hospital, 730 Ezu Tottori City, Tottori, 680-0901, Japan. 8. Center for Community Medicine, Jichi Medical University, 3311-1, Yakushiji Shimotsuke City, Tochigi, 329-0498, Japan. 9. Department of Musculoskeletal Traumatology, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan. 10. Department of Orthopedics, Foot and Ankle Research and Innovation Laboratory, Massachusetts General Hospital, Boston, USA. 11. Department of Orthopaedic Surgery, Dentistry and Pharmaceutical Science, Okayama University Graduate School of Medicine, Okayama, Japan.
Abstract
PURPOSE: This study aimed to determine the efficacy and safety of cement augmentation for internally fixed trochanteric fractures through a systematic review and meta-analysis of randomized controlled trials (RCTs). METHODS: We searched the MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov databases to identify RCTs, published until July 2020 that examined the effects of cement augmentation of internal fixation of trochanteric fractures. The primary outcomes were reoperation and Parker Mobility Score, whereas the secondary outcomes were 1-year mortality rate, EuroQol 5 Dimension, fixation failures, and adverse events. We conducted meta-analyses of the outcome measures using the random-effects models. We evaluated the certainty of evidence based on the Cochrane risk-of-bias tool and the Grading of Recommendations, Assessment, Development, and Evaluation approach. RESULTS: We included three RCTs (326 participants). No significant effect was observed in favor of cement augmentation on all these outcomes. The certainty of evidence for fixation failures was very low and that for the other outcomes was low. The overall risk of bias for each outcome was high or of some concern in all included studies. CONCLUSIONS: The effect of cement augmentation of internal fixation of trochanteric fractures was uncertain for the clinical outcomes due to the low certainty of evidence. Further RCTs with a low risk of selection bias may present convincing conclusions on the efficacy and safety of cement augmentation. LEVEL OF EVIDENCE: Level 1.
PURPOSE: This study aimed to determine the efficacy and safety of cement augmentation for internally fixed trochanteric fractures through a systematic review and meta-analysis of randomized controlled trials (RCTs). METHODS: We searched the MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov databases to identify RCTs, published until July 2020 that examined the effects of cement augmentation of internal fixation of trochanteric fractures. The primary outcomes were reoperation and Parker Mobility Score, whereas the secondary outcomes were 1-year mortality rate, EuroQol 5 Dimension, fixation failures, and adverse events. We conducted meta-analyses of the outcome measures using the random-effects models. We evaluated the certainty of evidence based on the Cochrane risk-of-bias tool and the Grading of Recommendations, Assessment, Development, and Evaluation approach. RESULTS: We included three RCTs (326 participants). No significant effect was observed in favor of cement augmentation on all these outcomes. The certainty of evidence for fixation failures was very low and that for the other outcomes was low. The overall risk of bias for each outcome was high or of some concern in all included studies. CONCLUSIONS: The effect of cement augmentation of internal fixation of trochanteric fractures was uncertain for the clinical outcomes due to the low certainty of evidence. Further RCTs with a low risk of selection bias may present convincing conclusions on the efficacy and safety of cement augmentation. LEVEL OF EVIDENCE: Level 1.
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