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An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery

Overview

Información sobre este estudio

The primary objective of this study is to evaluate sternal bone healing following a full median sternotomy versus standard of care for sternal closure with wire cerclage. Additional outcomes on post-operative pain and analgesic usage, patient function and quality of life, and complications will also be collected. A health economics study will also be conducted, in which cost and billing data will be collected from sites participating in this clinical study.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Patients undergoing a full standard midline sternotomy as a result of a cardiac surgical procedure (i.e. coronary artery bypass graft (CABG) and/or valve replacement along with other cardiac surgical procedures)
  • Patients admitted to the hospital the day of or the day before their scheduled surgical procedure
  • Patients ≥ 18 years of age
  • Patients with a BMI < 40

Exclusion Criteria:

Pre-operative

  • Patients with endstage renal failure who are on dialysis
  • Patients with severe chronic obstructive pulmonary disease (COPD) (FEV1 < 50% or patients on on-home oxygen)
  • Patients on prescribed pre-operative narcotics
  • Patients taking chronic steroids, biologics acting as immunosuppressants (e.g. Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab), or chemotherapeutics (iv or oral chemotherapeutics for cancer). Patients using a steroid inhaler for asthma should not be excluded.
  • Patients with an active infection as defined by a positive culture
  • Patients with foreign body sensitivity
  • Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions
  • Patients defined within the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) functional Class IV for congestive heart failure: i.e., patients with cardiac disease resulting in inability to carry on any physical activity without discomfort (CCS ; NYHA)
  • Patients presenting emergent/salvage cardiac acuity as defined per the Society of Thoracic Surgeons (STS) guidelines: i.e., patients undergoing cardiopulmonary resuscitation en route to the operating room or prior to induction of anesthesia (STS)
  • Patients unwilling or unable to return for follow-up

Operative

  • Patients requiring delayed sternotomy closure
  • Patients with an off-midline sternotomy reducing the bony margin between a SternaLock screw body and an osteotomy to within 2mm or less
  • Patients presenting intra-operative conditions that in the opinion of the treating surgeon would require or preclude the use of either wire cerclage or rigid fixation, or who are not able to be plated or wired per the protocol (e.g. patients who in the opinion of the surgeon have insufficient quantity of quality of sternal bone; redo sternotomy with excessive fibrous tissue)
  • Use of non resorbable (beeswax) bonewax
  • Intraoperative death prior to device placement

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Kevin Landolfo, M.D.

Cerrado para la inscripción

More information

Publicaciones

  • 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. Read More on PubMed
  • Postoperative sternal wound complications are a significant problem in high-risk patients. In addition to closure with conventional wires, several systems involving rigid fixation with metal plates are currently available. The rapid sternal closure system (Talon) is approved for stabilization and fixation of the anterior chest wall. Anecdotal evidence suggests that use of the Talon may result in improved postoperative recovery. Read More on PubMed
  • Deep sternal infections secondary to bony instability and malunion, can result in mediastinitis. Previous authors have described the use of prophylactic rigid plate fixation in high-risk patients. The purpose of our study is to review the use of prophylactic sternal platting with pectoralis advancement flaps in high-risk patients with a history of chest irradiation. Fourteen patients (July 2003-September 2008) with a history of chest irradiation who underwent a median sternotomy followed by prophylactic rigid plate fixation of the sternum were reviewed. Breast cancer was the most common etiology of chest irradiation (n=11, 78%). The average EuroSCORE was 24.06% with 72% of patients having a preoperative New York Heart Association (NYHA) class≥III. There were no episodes of sternal non-union, mediastinitis or death. Follow-up was 100% with a 0% 30-day and a 7.1% one-year mortality rate (non-cardiac). A comparison between mean preoperative left ventricular ejection fraction (LVEF) (49.6%) and postoperative LVEF (59.7%) was statistically significant (P<0.0001). All living patients currently maintain a NYHA class I/II. Prophylactic rigid plate fixation and pectoralis flap coverage decreases the risk of developing sternal dehiscence and postoperative wound complications and should therefore be considered in high-risk patients with a history of chest irradiation. Read More on PubMed
  • Optimal surgical treatment of unstable sternal fractures is controversial. Wiring provides suboptimal fixation and adaptations of existing non-sternum specific plating systems may be dangerous when rapid sternal reentry is required. We present our experience with the sternal specific fixation system, SternaLock (Biomet Microfixation Inc, Jacksonville, FL), in the acute treatment of transverse sternal body fractures in 2 patients who sustained significant blunt anterior chest wall trauma. SternaLock provides the rigid sternal fixation necessary for reliable fracture healing while offering advantages over other systems with regards to ease of use and safety. Read More on PubMed
  • During the past five years, ridged sternal fixation has been utilized for sternal closure after cardiac surgery. It is known that this procedure provides better sternal stability; however, its contribution to patient recovery has not been investigated. Read More on PubMed
  • Postoperative mediastinitis is a serious and potentially lethal complication from cardiac surgery. Although postoperative mediastinitis cannot be reliably predicted, a number of preoperative and intraoperative risk factors have been defined by previous work. The authors now present their cumulative experience with primary sternal fixation of high-risk patients as one preventative measure. Read More on PubMed
  • Sternal closure with rigid titanium plates (primary sternal plating) may reduce sternal wound complications in high-risk patients. We began performing primary sternal plating for the following indications: obesity, manual laborer, osteoporotic sternum, or intraoperative transverse sternal fracture. Patients receiving plate closure were compared to a risk-matched control group receiving wire closure. Outcomes of interest were postoperative length of stay and sternal wound complications [sterile dehiscence or deep sternal wound infection (DSWI)]. Wound complications were classified by time of occurrence as early (30 days postoperation). Of 445 total cardiac cases during the 5-year study period, 129 (29%) met inclusion criteria. The plate group (n=30) and wire group (n=99) were generally well-matched in terms of risk factors. Postoperative length of stay was significantly shorter in the plate group (median 7 vs. 8 days, P=0.023). No early sternal wound complications occurred in the plate group, compared to 12 (12%) in the wire group (P=0.067). The incidence of late sternal wound complications was 10% in both groups (P=1.0). Primary sternal plating appears to provide benefits over wire closure during the early postoperative period, but may not prevent late wound complications in patients with osteoporosis or extreme obesity. Read More on PubMed
  • Reconstruction of sternal nonunion following surgical resection can be difficult. Presented here is a case of sternal salvage with rigid fixation in the face of a massive aortic pseudoaneurysm. Plating is a safe and efficient technique that provides bone approximation and results in long term rigid sternal fixation. This case report highlights the history and biomechanical theory and examines the safety and clinical outcomes of sternal reconstruction with plating fixation. Read More on PubMed
  • 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. Read More on PubMed
  • 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. Read More on PubMed
  • Mediastinitis and sternal wound dehiscence are devastating and life-threatening complications of median sternotomy incision. Ten consecutive patients between July 2001 and May 2005 were diagnosed with sternal wound infection and dehiscence following median sternotomy. Patients were managed by precise debridement and wound excision in the operating room and then dressed with vacuum-assisted closure device. Intravenous antibiotics were prescribed for wound and blood culture microbiological sensitivity. When wounds were bacteriologically controlled, patients returned to the operating room for definitive closure using rigid sternal plating. All patients were extubated postoperatively. No patients died. Average total hospital stay was 21 days. The pectoralis advancement flap was exclusively used for soft tissue reconstruction in 7 patients. There were 2 cases of chronic superficial sternal infection requiring plate removal; however, bony union of the sternum was achieved in all patients. This treatment algorithm provides a useful management strategy for patients with complicated median sternotomy. Read More on PubMed
  • The incidence of severe sternal wound complications in high-risk cardiac patients presents a significant need for more stabile sternal fixation techniques after median sternotomy procedures. Rigid metal plates, a potential alternative to wire fixation, are thought to promote faster sternal healing by reducing motion at the wound site. The goal of this study was to compare the stability provided by commercially available sternal plates with standard wires using an in vitro model. Read More on PubMed
  • 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. Read More on PubMed
  • Sternal dehiscence is a complication of median sternotomy incisions with high mortality and morbidity. Different techniques of sternal closure have been described. Rigid fixation of the sternum results in earlier union. We measured the rigidity of sternotomy fixation using a mechanical model in order to differentiate different techniques of sternal closure using their biomechanical characteristics. Read More on PubMed

Otros temas en investigación

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CLS-20119477

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