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Keith B Allen - One of the best experts on this subject based on the ideXlab platform.
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sternotomy closure using Rigid Plate fixation a paradigm shift from wire cerclage
Annals of cardiothoracic surgery, 2018Co-Authors: Keith B Allen, Kendra J Grubb, John Grehan, Kevin Landolfo, Vinod H. Thourani, Yoshifumi Naka, Kyle J Icke, Nirav C Patel, Sloane T Guy, Marc W GerdischAbstract:Background: Rigid Plate fixation (RPF) is the cornerstone in managing fractures and osteotomies except for sternotomy, where most cardiac surgeons continue to use wire cerclage (WC). Results of a multicenter randomized trial evaluating sternal healing, sternal complications, patient reported outcome measures (PROMs), and costs after sternotomy closure with RPF or WC are summarized here. Methods: Twelve US centers randomized 236 patients to either RPF (n=116) or WC (n=120). The primary endpoint, sternal healing at 6 months, was evaluated by a core laboratory using computed tomography and a validated 6-point scale (greater scores represent greater healing). Secondary endpoints assessed through 6 months included sternal complications and PROMs. Costs from the time of sternal closure through 90 days and 6 months were analyzed by a health economic core laboratory. Results: RPF compared to WC resulted in better sternal healing scores at 3 (2.6±1.1 vs. 1.8±1.0; P<0.0001) and 6 months (3.8±1.0 vs. 3.3±1.1; P=0.0007) and higher sternal union rates at 3 [41% (42/103) vs. 16% (16/102); P<0.0001] and 6 months [80% (81/101) vs. 67% (67/100); P=0.03]. There were fewer sternal complications with RPF through 6 months [0% (0/116) vs. 5% (6/120); P=0.03] and a trend towards fewer sternal wound infections [0% (0/116) vs. 4.2% (5/120); P=0.06]. All PROMs including sternal pain, upper extremity function (UEF), and quality-of-life scores were numerically better in RPF patients compared to WC patients at all follow-up time points. Although RPF was associated with a trend toward higher index hospitalization costs, a trend towards lower follow-up costs resulted in total costs that were $1,888 less at 90 days in RPF patients compared to WC patients (95% CI: −$8,889 to $4,273; P=0.52) and $1,646 less at 6 months (95% CI: –$9,127 to $4,706; P=0.61). Conclusions: Sternotomy closure with RPF resulted in significantly better sternal healing, fewer sternal complications, improved PROMs and was cost neutral through 90 days and 6 months compared to WC.
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Rigid Plate fixation versus wire cerclage patient reported and economic outcomes from a randomized trial
The Annals of Thoracic Surgery, 2018Co-Authors: Keith B Allen, Kendra J Grubb, John Grehan, Marc W Gerdisch, Kevin Landolfo, Vinod H. Thourani, Yoshifumi Naka, Nirav C Patel, Sloane T Guy, Mark R BonnellAbstract:Background In a multicenter randomized trial, sternal closure after cardiac operations using Rigid Plate fixation (RPF) compared with wire cerclage (WC) resulted in improved sternal healing, reduced sternal complications, and was cost neutral at 6 months. Additional secondary end points are presented from this trial. Methods Twelve United States centers randomized 236 patients to RPF (n = 116) or WC (n = 120). Patient-reported outcomes measures, including pain, function, and quality of life scores, were assessed through 6 months and correlated to computed tomography–derived sternal healing scores using logistic regression. Cost analysis through 90 days was performed to mimic bundled care models. Results All patient-reported outcomes measures were numerically better in RPF patients than in WC patients at all assessments. RPF resulted in more patients reporting no sternal pain after coughing at 3 weeks (41.1% vs 19.6%; p = 0.001) and 6 weeks (54.5% vs 35.1%; p = 0.005) and at rest at 6 weeks (74.1% vs 58.8%; p = 0.02) and 3 months (87.6% vs 75.9%; p = 0.03) compared with WC. Better sternal healing scores correlated to having no sternal pain at rest (odds ratio, 1.6; 95% confidence interval, 1.2 to 2.2; p = 0.002) and after coughing (odds ratio, 1.6; 95% confidence interval, 1.2 to 2.2; p = 0.0007). RPF resulted in improvements in the 36-Item Short Form Health Survey quality of life scores at 3 weeks (53.5 ± 8.7 vs 50.5 ± 10.4; p = 0.03), 6 weeks (45.3 ± 8.4 vs 42.7 ± 8.4; p = 0.03), and 6 months (56.4 ± 6.8 vs 53.9 ± 9.0; p = 0.04) compared with WC. Through 90 days, RPF compared with WC was $1,888 less (95% confidence interval, –$8,889 to $4,273; p = 0.52). Conclusions In patients undergoing sternal closure after median sternotomy, RPF compared with WC resulted in reduced sternal pain, improved upper extremity function, and similar total 90-day costs.
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randomized multicenter trial comparing sternotomy closure with Rigid Plate fixation to wire cerclage
The Journal of Thoracic and Cardiovascular Surgery, 2017Co-Authors: Keith B Allen, Kendra J Grubb, John Grehan, Marc W Gerdisch, Mark R Bonnell, Kevin Landolfo, Vinod H. Thourani, Nirav Patel, Yoshifumi Naka, David J. CohenAbstract:Abstract Objective To evaluate sternal healing, complications, and costs after sternotomy closure with Rigid Plate fixation or wire cerclage. Methods This prospective, single-blinded, multicenter trial randomized 236 patients at 12 US centers at the time of sternal closure to either Rigid Plate fixation (n = 116) or wire cerclage (n = 120). The primary endpoint, sternal healing at 6 months, was evaluated by a core laboratory using computed tomography and a 6-point scale (greater scores represent greater healing). Secondary endpoints included sternal complications and costs from the time of sternal closure through 6 months. Results Rigid Plate fixation resulted in better sternal healing scores at 3 (2.6 ± 1.1 vs 1.8 ± 1.0; P P = .0007) and greater sternal union rates at 3 (41% [42/103] vs 16% [16/102]; P P = .03) compared with wire cerclage. There were fewer sternal complications through 6 months with Rigid Plate fixation (0% [0/116] vs 5% [6/120]; P = .03) and a trend towards fewer sternal wound infections (0% [0/116] vs 4.2% [5/120]; P = .06) compared with wire cerclage. Although Rigid Plate fixation was associated with a trend toward greater index hospitalization costs ($23,437 vs $20,574; P = .11), 6-month follow-up costs tended to be lower ($9002 vs $13,511; P = .14). As a result, total costs from randomization through 6 months were similar between groups ($32,439 vs $34,085; P = .61). Conclusions Sternotomy closure with Rigid Plate fixation resulted in significantly better sternal healing, fewer sternal complications, and no additional cost compared with wire cerclage at 6 months after surgery.
Jaishankar Raman - One of the best experts on this subject based on the ideXlab platform.
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sternal closure with Rigid Plate fixation versus wire closure a randomized controlled multicenter trial
The Annals of Thoracic Surgery, 2012Co-Authors: Jaishankar Raman, Kenton Zehr, Brian J De Guzman, Edward H Garrett, Brian M Hatcher, Lishan Aklog, Heber Macmahon, S. Lehmann, Michael S. WongAbstract:Background Rigid bone fixation is the standard of care for all bone reconstructions except that after sternotomy. Sternal reconstruction after median sternotomy using Rigid fixation with Plates may improve bone healing and reduce pain when compared with wire cerclage. Methods One-hundred forty patients at six centers who were determined preoperatively to be at high risk for sternal wound complications were randomly assigned to sternal closure with Rigid Plate fixation (n = 70) or wire cerclage (n = 70). Sternal healing was evaluated at 3 or 6 months by a core laboratory using computed tomography. Pain and function were evaluated at postoperative day 3 through discharge, 3 weeks, 6 weeks, 3 months, and 6 months. Results Sternal healing was superior in Rigid Plate fixation patients at both 3 and 6 months. Mean computed tomography scores in the Rigid Plate fixation and wire cerclage groups at 3 months were 1.7 ± 1.1 and 0.9 ± 0.8 ( p = 0.003). At 6 months, the scores were 3.2 ± 1.6 and 2.2 ± 1.1, respectively ( p = 0.01). At 6 months, 70% of Rigid Plate fixation patients had achieved sternal union, compared with 24% of conventional wire cerclage patients ( p = 0.003). Pain scores and narcotic usage were lower in Rigid Plate fixation patients. Significant differences in pain scores were observed at 3 weeks for total pain ( p = 0.020) and pain with coughing ( p = 0.0084) or sneezing ( p = 0.030). Complication rates were similar in both groups. Conclusions Sternal reconstruction using Rigid fixation with Plates improved bone healing and reduced early postoperative pain compared with wire cerclage.
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Rigid Plate fixation promotes better bone healing after sternotomy.
Seminars in Thoracic and Cardiovascular Surgery, 2012Co-Authors: Jaishankar RamanAbstract:Sternotomy is the most common surgically created osteotomy in surgery. Rigid fixation of osteotomies are important for stability and bony union. This review shows the superiority of Rigid Plate fixation in achieving better bone healing after sternotomy. It also highlights use of Plate fixation for mini-sternotomies and rib fractures.
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Rigid Plate fixation of the sternum.
The Annals of Thoracic Surgery, 2007Co-Authors: Jaishankar Raman, David J. Straus, David H. SongAbstract:Sternotomy is the most common osteotomy performed worldwide and has traditionally been closed by wire circlage. Recent studies have demonstrated the superiority of internal Plate fixation both in promoting bony stability and osteosynthesis and in decreasing the incidence of postoperative mediastinitis. Despite its advantages, this method of sternal closure has not yet gained widespread use. We describe a simple technique of sternal closure using Plates secured with screws.
David H. Song - One of the best experts on this subject based on the ideXlab platform.
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Rigid Plate fixation of the sternum.
The Annals of Thoracic Surgery, 2007Co-Authors: Jaishankar Raman, David J. Straus, David H. SongAbstract:Sternotomy is the most common osteotomy performed worldwide and has traditionally been closed by wire circlage. Recent studies have demonstrated the superiority of internal Plate fixation both in promoting bony stability and osteosynthesis and in decreasing the incidence of postoperative mediastinitis. Despite its advantages, this method of sternal closure has not yet gained widespread use. We describe a simple technique of sternal closure using Plates secured with screws.
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sternal closure with titanium Plate fixation a paradigm shift in preventing mediastinitis
Interactive Cardiovascular and Thoracic Surgery, 2006Co-Authors: Jai Raman, Gil Bolotin, David H. Song, Valluvan JeevanandamAbstract:: Sternal instability predisposes to post-operative mediastinitis. Biomechanical studies have shown the superiority of Rigid Plate fixation over wire circlage in sternal healing. We studied Rigid Plate fixation for sternotomies in high-risk patients. High-risk patients were identified as those having three or more historically established risk factors for post-operative mediastinitis, such as COPD, re-operative surgery, renal failure, diabetes, steroid use, obesity, existing infection, and immunosuppression. Three hundred and twenty high-risk patients had prophylactic Rigid Plate fixation (Group S) between July 2000 and Jan 2005. The control group (Group C) comprised 215 patients with similar risk profiles that were not Plated during 2000 and 2001. Average age, male-female ratio, risk factors and type of procedures were similar in both groups. Follow up ranged from 4 to 200 weeks. There were 12 peri-operative deaths (3.75%) in group S and 8.6% (18 patients) in group C. There were no instances of deep mediastinitis in group S. Group C had mediastinitis in 28 (13%, P<0.05), requiring high dose antibiotics and plastic surgical intervention. Sternal fixation with titanium Plates is an effective way of ensuring sternal immobility thereby reducing the substrate for bony infections. Application of this technique in high-risk patients prevents mediastinitis.
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primary sternal plating in high risk patients prevents mediastinitis
European Journal of Cardio-Thoracic Surgery, 2004Co-Authors: David H. Song, Valluvan Jeevanandam, Robert F Lohman, John Renucci, Jai RamanAbstract:OBJECTIVE: Sternal wound infection leading to post-operative mediastinitis is a devastating complication of cardiac surgery carrying nearly a 15% mortality rate despite current treatment methods. Instability of bone fragments pre-disposes a patient to have non-union, mal-union and can subsequently lead to deep sternal wound infections progressing to mediastinitis. Rigid Plate fixation has been utilized for acquired and surgically created fractures of virtually every bone in the body to prevent instability. However, the current standard for sternotomy closure remains the method of wire-circlage. Application of Rigid Plate fixation for sternal osteotomies affords greater stability of the sternum. We report on our preliminary experience with this technique in high-risk patients. METHODS: From July of 2000 to December 2001, Rigid Plate fixation was applied to 45 patients designated as having high risk for sternal dehiscence and subsequent mediastinitis. High risk was defined as patients having 3 or more established historical risk factors, including: COPD, Re-Operative Surgery, Renal Failure, Diabetes, Chronic Steroid Use, Morbid Obesity, Concurrent Infection and Acquired or Iatrogenic Immunosuppression. Intra-operative risk factors included off-midline sternotomy, osteoporosis, long cardio-pulmonary bypass runs (>2 h), transverse fractures of the sternum. Rigid Plate fixation was performed using a combination of Plates secured by bi-cortical screws, after the cardiac surgical procedure was complete and hemostasis was secured. RESULTS: Rigid Plate fixation was performed on 26 males and 19 females. The average age of patients was 63 (43-88) years. The average follow-up was 15 weeks (range 8-41 weeks). While there were 4 peri-operative deaths unrelated to sternal closure: one from aspiration pneumonia (post-operative day 9), one from a pulmonary embolus (post-operative day 29), one from overwhelming sepsis from pre-existing endocarditis (post-operative day 15), and one for primary respiratory failure (post-operative day 12). All others healed successfully. One patient who had a sterile dehiscence subsequently underwent successful re-operative Rigid fixation. Comparing the cohort of patients who received Rigid Plate fixation to a matched population of high-risk patients during a similar time period who received wire closure, revealed a significant difference in the incidence of post-operative mediastinitis. The wire closed group (n = 207) had 18 deaths unrelated to sternal closure and had 28 patients who developed mediastinitis (14.8%). The Rigid Plate fixation group had no mediastinitis (Fisher's exact test, P = 0.006). The total incidence of post-operative mediastinitis during the designated study period was 4.2%. CONCLUSION: Patients who benefited from sternal closure with Rigid Plate fixation showed a significant decrease in the incidence of post-operative mediastinitis when compared to similar population of patients whose sterna were closed with wire.
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Rigid-Plate fixation for the treatment of sternal nonunion.
The Journal of thoracic and cardiovascular surgery, 2004Co-Authors: John D. Renucci, David H. SongAbstract:Sterile sternal nonunion is defined as a persistent fracture of the sternum after 3 months without signs of healing. It is a morbid condition characterized by sternal instability, pain, and the absence of infection. In addition to being a crippling condition, one can assume that sternal instability can lead to more serious conditions. Two causes for sternal nonunion have been described: it can be the result of cardiac surgical intervention or trauma. Regardless of the cause, only a few studies have addressed the entity of sterile sternal nonunion and its treatment. We present 6 cases of sterile sternal nonunion, including its presentation, treatment with open reduction and Rigid-Plate fixation with the Sternalock system (W. Lorenz Surgical, Inc, Jacksonville, Fla), and the outcomes.
Mark R Bonnell - One of the best experts on this subject based on the ideXlab platform.
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Rigid Plate fixation versus wire cerclage patient reported and economic outcomes from a randomized trial
The Annals of Thoracic Surgery, 2018Co-Authors: Keith B Allen, Kendra J Grubb, John Grehan, Marc W Gerdisch, Kevin Landolfo, Vinod H. Thourani, Yoshifumi Naka, Nirav C Patel, Sloane T Guy, Mark R BonnellAbstract:Background In a multicenter randomized trial, sternal closure after cardiac operations using Rigid Plate fixation (RPF) compared with wire cerclage (WC) resulted in improved sternal healing, reduced sternal complications, and was cost neutral at 6 months. Additional secondary end points are presented from this trial. Methods Twelve United States centers randomized 236 patients to RPF (n = 116) or WC (n = 120). Patient-reported outcomes measures, including pain, function, and quality of life scores, were assessed through 6 months and correlated to computed tomography–derived sternal healing scores using logistic regression. Cost analysis through 90 days was performed to mimic bundled care models. Results All patient-reported outcomes measures were numerically better in RPF patients than in WC patients at all assessments. RPF resulted in more patients reporting no sternal pain after coughing at 3 weeks (41.1% vs 19.6%; p = 0.001) and 6 weeks (54.5% vs 35.1%; p = 0.005) and at rest at 6 weeks (74.1% vs 58.8%; p = 0.02) and 3 months (87.6% vs 75.9%; p = 0.03) compared with WC. Better sternal healing scores correlated to having no sternal pain at rest (odds ratio, 1.6; 95% confidence interval, 1.2 to 2.2; p = 0.002) and after coughing (odds ratio, 1.6; 95% confidence interval, 1.2 to 2.2; p = 0.0007). RPF resulted in improvements in the 36-Item Short Form Health Survey quality of life scores at 3 weeks (53.5 ± 8.7 vs 50.5 ± 10.4; p = 0.03), 6 weeks (45.3 ± 8.4 vs 42.7 ± 8.4; p = 0.03), and 6 months (56.4 ± 6.8 vs 53.9 ± 9.0; p = 0.04) compared with WC. Through 90 days, RPF compared with WC was $1,888 less (95% confidence interval, –$8,889 to $4,273; p = 0.52). Conclusions In patients undergoing sternal closure after median sternotomy, RPF compared with WC resulted in reduced sternal pain, improved upper extremity function, and similar total 90-day costs.
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randomized multicenter trial comparing sternotomy closure with Rigid Plate fixation to wire cerclage
The Journal of Thoracic and Cardiovascular Surgery, 2017Co-Authors: Keith B Allen, Kendra J Grubb, John Grehan, Marc W Gerdisch, Mark R Bonnell, Kevin Landolfo, Vinod H. Thourani, Nirav Patel, Yoshifumi Naka, David J. CohenAbstract:Abstract Objective To evaluate sternal healing, complications, and costs after sternotomy closure with Rigid Plate fixation or wire cerclage. Methods This prospective, single-blinded, multicenter trial randomized 236 patients at 12 US centers at the time of sternal closure to either Rigid Plate fixation (n = 116) or wire cerclage (n = 120). The primary endpoint, sternal healing at 6 months, was evaluated by a core laboratory using computed tomography and a 6-point scale (greater scores represent greater healing). Secondary endpoints included sternal complications and costs from the time of sternal closure through 6 months. Results Rigid Plate fixation resulted in better sternal healing scores at 3 (2.6 ± 1.1 vs 1.8 ± 1.0; P P = .0007) and greater sternal union rates at 3 (41% [42/103] vs 16% [16/102]; P P = .03) compared with wire cerclage. There were fewer sternal complications through 6 months with Rigid Plate fixation (0% [0/116] vs 5% [6/120]; P = .03) and a trend towards fewer sternal wound infections (0% [0/116] vs 4.2% [5/120]; P = .06) compared with wire cerclage. Although Rigid Plate fixation was associated with a trend toward greater index hospitalization costs ($23,437 vs $20,574; P = .11), 6-month follow-up costs tended to be lower ($9002 vs $13,511; P = .14). As a result, total costs from randomization through 6 months were similar between groups ($32,439 vs $34,085; P = .61). Conclusions Sternotomy closure with Rigid Plate fixation resulted in significantly better sternal healing, fewer sternal complications, and no additional cost compared with wire cerclage at 6 months after surgery.
Marc W Gerdisch - One of the best experts on this subject based on the ideXlab platform.
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sternotomy closure using Rigid Plate fixation a paradigm shift from wire cerclage
Annals of cardiothoracic surgery, 2018Co-Authors: Keith B Allen, Kendra J Grubb, John Grehan, Kevin Landolfo, Vinod H. Thourani, Yoshifumi Naka, Kyle J Icke, Nirav C Patel, Sloane T Guy, Marc W GerdischAbstract:Background: Rigid Plate fixation (RPF) is the cornerstone in managing fractures and osteotomies except for sternotomy, where most cardiac surgeons continue to use wire cerclage (WC). Results of a multicenter randomized trial evaluating sternal healing, sternal complications, patient reported outcome measures (PROMs), and costs after sternotomy closure with RPF or WC are summarized here. Methods: Twelve US centers randomized 236 patients to either RPF (n=116) or WC (n=120). The primary endpoint, sternal healing at 6 months, was evaluated by a core laboratory using computed tomography and a validated 6-point scale (greater scores represent greater healing). Secondary endpoints assessed through 6 months included sternal complications and PROMs. Costs from the time of sternal closure through 90 days and 6 months were analyzed by a health economic core laboratory. Results: RPF compared to WC resulted in better sternal healing scores at 3 (2.6±1.1 vs. 1.8±1.0; P<0.0001) and 6 months (3.8±1.0 vs. 3.3±1.1; P=0.0007) and higher sternal union rates at 3 [41% (42/103) vs. 16% (16/102); P<0.0001] and 6 months [80% (81/101) vs. 67% (67/100); P=0.03]. There were fewer sternal complications with RPF through 6 months [0% (0/116) vs. 5% (6/120); P=0.03] and a trend towards fewer sternal wound infections [0% (0/116) vs. 4.2% (5/120); P=0.06]. All PROMs including sternal pain, upper extremity function (UEF), and quality-of-life scores were numerically better in RPF patients compared to WC patients at all follow-up time points. Although RPF was associated with a trend toward higher index hospitalization costs, a trend towards lower follow-up costs resulted in total costs that were $1,888 less at 90 days in RPF patients compared to WC patients (95% CI: −$8,889 to $4,273; P=0.52) and $1,646 less at 6 months (95% CI: –$9,127 to $4,706; P=0.61). Conclusions: Sternotomy closure with RPF resulted in significantly better sternal healing, fewer sternal complications, improved PROMs and was cost neutral through 90 days and 6 months compared to WC.
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Rigid Plate fixation versus wire cerclage patient reported and economic outcomes from a randomized trial
The Annals of Thoracic Surgery, 2018Co-Authors: Keith B Allen, Kendra J Grubb, John Grehan, Marc W Gerdisch, Kevin Landolfo, Vinod H. Thourani, Yoshifumi Naka, Nirav C Patel, Sloane T Guy, Mark R BonnellAbstract:Background In a multicenter randomized trial, sternal closure after cardiac operations using Rigid Plate fixation (RPF) compared with wire cerclage (WC) resulted in improved sternal healing, reduced sternal complications, and was cost neutral at 6 months. Additional secondary end points are presented from this trial. Methods Twelve United States centers randomized 236 patients to RPF (n = 116) or WC (n = 120). Patient-reported outcomes measures, including pain, function, and quality of life scores, were assessed through 6 months and correlated to computed tomography–derived sternal healing scores using logistic regression. Cost analysis through 90 days was performed to mimic bundled care models. Results All patient-reported outcomes measures were numerically better in RPF patients than in WC patients at all assessments. RPF resulted in more patients reporting no sternal pain after coughing at 3 weeks (41.1% vs 19.6%; p = 0.001) and 6 weeks (54.5% vs 35.1%; p = 0.005) and at rest at 6 weeks (74.1% vs 58.8%; p = 0.02) and 3 months (87.6% vs 75.9%; p = 0.03) compared with WC. Better sternal healing scores correlated to having no sternal pain at rest (odds ratio, 1.6; 95% confidence interval, 1.2 to 2.2; p = 0.002) and after coughing (odds ratio, 1.6; 95% confidence interval, 1.2 to 2.2; p = 0.0007). RPF resulted in improvements in the 36-Item Short Form Health Survey quality of life scores at 3 weeks (53.5 ± 8.7 vs 50.5 ± 10.4; p = 0.03), 6 weeks (45.3 ± 8.4 vs 42.7 ± 8.4; p = 0.03), and 6 months (56.4 ± 6.8 vs 53.9 ± 9.0; p = 0.04) compared with WC. Through 90 days, RPF compared with WC was $1,888 less (95% confidence interval, –$8,889 to $4,273; p = 0.52). Conclusions In patients undergoing sternal closure after median sternotomy, RPF compared with WC resulted in reduced sternal pain, improved upper extremity function, and similar total 90-day costs.
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randomized multicenter trial comparing sternotomy closure with Rigid Plate fixation to wire cerclage
The Journal of Thoracic and Cardiovascular Surgery, 2017Co-Authors: Keith B Allen, Kendra J Grubb, John Grehan, Marc W Gerdisch, Mark R Bonnell, Kevin Landolfo, Vinod H. Thourani, Nirav Patel, Yoshifumi Naka, David J. CohenAbstract:Abstract Objective To evaluate sternal healing, complications, and costs after sternotomy closure with Rigid Plate fixation or wire cerclage. Methods This prospective, single-blinded, multicenter trial randomized 236 patients at 12 US centers at the time of sternal closure to either Rigid Plate fixation (n = 116) or wire cerclage (n = 120). The primary endpoint, sternal healing at 6 months, was evaluated by a core laboratory using computed tomography and a 6-point scale (greater scores represent greater healing). Secondary endpoints included sternal complications and costs from the time of sternal closure through 6 months. Results Rigid Plate fixation resulted in better sternal healing scores at 3 (2.6 ± 1.1 vs 1.8 ± 1.0; P P = .0007) and greater sternal union rates at 3 (41% [42/103] vs 16% [16/102]; P P = .03) compared with wire cerclage. There were fewer sternal complications through 6 months with Rigid Plate fixation (0% [0/116] vs 5% [6/120]; P = .03) and a trend towards fewer sternal wound infections (0% [0/116] vs 4.2% [5/120]; P = .06) compared with wire cerclage. Although Rigid Plate fixation was associated with a trend toward greater index hospitalization costs ($23,437 vs $20,574; P = .11), 6-month follow-up costs tended to be lower ($9002 vs $13,511; P = .14). As a result, total costs from randomization through 6 months were similar between groups ($32,439 vs $34,085; P = .61). Conclusions Sternotomy closure with Rigid Plate fixation resulted in significantly better sternal healing, fewer sternal complications, and no additional cost compared with wire cerclage at 6 months after surgery.
