Dataset Information

The Sternal Management Accelerated Recovery Trial (S.M.A.R.T) - standard restrictive versus an intervention of modified sternal precautions following cardiac surgery via median sternotomy: study protocol for a randomised controlled trial.

ABSTRACT:

Background

The routine implementation of sternal precautions to prevent sternal complications that restrict the use of the upper limbs is currently worldwide practice following a median sternotomy. However, evidence is limited and drawn primarily from cadaver studies and orthopaedic research. Sternal precautions may delay recovery, prolong hospital discharge and be overly restrictive. Recent research has shown that upper limb exercise reduces post-operative sternal pain and results in minimal micromotion between the sternal edges as measured by ultrasound. The aims of this study are to evaluate the effects of modified sternal precautions on physical function, pain, recovery and health-related quality of life after cardiac surgery.

Methods/design

This study is a phase II, double-blind, randomised controlled trial with concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. Patients (n = 72) will be recruited following cardiac surgery via a median sternotomy. Sample size calculations were based on the minimal important difference (two points) for the primary outcome: Short Physical Performance Battery. Thirty-six participants are required per group to counter dropout (20%). All participants will be randomised to receive either standard or modified sternal precautions. The intervention group will receive guidelines encouraging the safe use of the upper limbs. Secondary outcomes are upper limb function, pain, kinesiophobia and health-related quality of life. Descriptive statistics will be used to summarise data. The primary hypothesis will be examined by repeated-measures analysis of variance to evaluate the changes from baseline to 4 weeks post-operatively in the intervention arm compared with the usual-care arm. In all tests to be conducted, a p value <0.05 (two-tailed) will be considered statistically significant, and confidence intervals will be reported.

Discussion

The Sternal Management Accelerated Recovery Trial (S.M.A.R.T.) is a two-centre randomised controlled trial powered and designed to investigate whether the effects of modifying sternal precautions to include the safe use of the upper limbs and trunk impact patients' physical function and recovery following cardiac surgery via median sternotomy.

Trial registration

Australian and New Zealand Clinical Trials Registry identifier: ACTRN12615000968572 . Registered on 16 September 2015 (prospectively registered).

SUBMITTER: Katijjahbe MA

PROVIDER: S-EPMC5481951 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundSternal non-union is a rare but serious complication post cardiac surgery. It is defined as sternal pain with clicking, instability or both, lasting for more than 6 months in the absence of infection. It usually presents in an outpatient setting and is confirmed on computed tomography (CT) scanning. Despite many corrective methods described in the literature, there is a lack of consensus amongst cardiac surgeons as to the ideal surgical management of sternal non-union post cardiac surgery. We describe our experience of sternal plating combined with autologous iliac crest bone grafting (AICBG) for sternal fixation and explore its safety and feasibility in patients with non-union post cardiac surgery.Case descriptionPatients who underwent sternal non-union surgery between 2015 and 2020 were included. Their primary cardiac surgical interventions occurred between 2011-2018. Demographic, clinical and outcome data obtained from a local database was analyzed retrospectively. Surgical procedure: sternal edge debridement, plate fixation with screws, filling with AICBG. Due to variable pathoanatomy of non-union, residual wires and multiple fragments of poor bone quality were cut and the sternal halves were stabilised by titanium plates and screws. These were reinforced with AICBG applied in the residual sternal gap created after debridement. Seven patients were included in the study. Median age was 65 years (54-75 years). Four patients (57.1%) were male. Demographic risk factors for sternal non-union prior to their initial cardiac surgery included diabetes (N=6), smoking history (N=3), and a median body mass index (BMI) of 31.2 kg/m2. The median interval between primary surgery and sternal fixation was 2.2 years. There were no perioperative deaths. Complications post sternal plating such as iliac crest pain (n=3) and acute tubular necrosis (n=1) were managed conservatively with long-term resolution. None of the patients required further intervention post sternal fixation after a mean follow-up of 18.0 months.ConclusionsThe use of AICBG in addition to sternal plating is a viable and innovative method of treating sternal non-union post-cardiac surgery with lasting effects and without any serious long-term complications. However, further larger studies are required to validate our results.

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