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Sternotomy closure using rigid plate fixation: a paradigm shift from wire cerclage.

ABSTRACT: 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.

SUBMITTER: Allen KB

PROVIDER: S-EPMC6219953 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Sternotomy closure using rigid plate fixation: a paradigm shift from wire cerclage.

Allen Keith B KB Icke Kyle J KJ Thourani Vinod H VH Naka Yoshifumi Y Grubb Kendra J KJ Grehan John J Patel Nirav N Guy T Sloane TS Landolfo Kevin K Gerdisch Marc M Bonnell Mark M

Annals of cardiothoracic surgery 20180901 5

<h4>Background</h4>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.<h4>Methods</h4>Twelve US centers randomized 236 patients to either RPF (n=116) or WC (n=120). The prima ...[more]

PMID: 30505745

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Project description:BackgroundDisplaced olecranon fractures with a stable elbow joint are classified as Mayo type 2a or 2b and are commonly operated with tension band wiring, i.e. two K-wires and a cerclage. Retrospective studies have reported fewer reoperations and complications with cerclage fixation alone when compared to tension band wiring, though with similar long-term results. We decided to compare tension band wiring to cerclage fixation of displaced, stable olecranon fractures in adults in a randomized controlled trial.MethodsAll patients ≥ 18 years old with Mayo type 2a and 2b fractures presenting at Skåne University hospital will be eligible for study inclusion, unless exclusion criteria are met. Two hundred participants will be included and randomized 1:1 to cerclage fixation or tension band wiring. Outpatient physiotherapist follow-up appointments will be scheduled at 2 and 6 weeks and at 3, 12, and 36 months at the Dept. of Orthopaedics. A lateral view radiograph of the elbow will be analysed at 6 months. The primary outcome of our study is the rate of reoperations. Secondary outcomes are complication rates, severity of complications, and patient-reported outcome measures (QuickDASH, Short Musculoskeletal Function Assessment, pain level, and patient satisfaction). The sample size was calculated to give 80% power for detecting a statistically significant difference in reoperation rates (with alpha-value 0.05), based on a previous retrospective study.DiscussionReoperation and complication rates after tension band wiring of olecranon fractures are high. Treatment of these injuries is debated, and several ongoing trials compare tension band wiring with plate fixation, suture fixation, and non-operative treatment. As data from retrospective studies indicate that cerclage fixation may be superior to tension band wiring, we see a need for a randomized controlled trial comparing these methods. The WOW-OK Trial aims to obtain level-1 evidence that may influence treatment choice for this type of fracture.Trial registrationClinicalTrials.gov NCT05657899 . Registered on 16 November 2022. The trial complies with SPIRIT and CONSORT guidelines. The SPIRIT figure is found in Table 2.

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Sternotomy closure using rigid plate fixation: a paradigm shift from wire cerclage.

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Sternotomy closure using rigid plate fixation: a paradigm shift from wire cerclage.

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