Sternal Closure With SternaLock 360: First in Man Study (SL360)

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Zimmer Biomet

Status

Completed

Conditions

Sternal Fracture

Treatments

Device: Wire Cerclage
Device: SternaLock 360

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02686099
0614

Details and patient eligibility

About

The SternaLock 360 Sternal Closure Device combines the techniques of rigid fixation with a cerclage material into a single sternal closure system. The cerclage material serves to facilitate sternal approximation, and the plates and screws serve to provide rigid fixation and prevent sternal movement and separation. The combination of a cerclage material in combination with plate and screw fixation may also lead to increased stability compared to either method used as a standalone means of closure.

Full description

The purpose of this study is to evaluate a new technology for sternal closure that combines rigid plate fixation with a cerclage material in patients undergoing a cardiac surgery subsequent to a full median sternotomy. This study will evaluate intraoperative outcomes related to the surgical technique and performance of the device, sternal healing and stability, sternal wound complications and postoperative recovery (e.g. pain and functional status) in patients closed with this device. For comparative purposes, a control group of wire cerclage patients will be included.

Enrollment

50 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Patients undergoing a 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 ≥ 30 years of age
  • Patients who sign the Informed Consent

Exclusion Criteria: Pre-Operative

  • Patients with endstage renal failure who are on dialysis or post transplant patients
  • Patients taking chronic (>30 days) pre-operative narcotics
  • Patients taking chronic (>30 days) steroids, immunosuppressant (including biologic immunosuppressants such as Enbrel), or chemotherapeutics (e.g. methotrexate). Patients using a steroid inhaler for asthma should not be excluded.
  • Patients with confirmed HIV with a viral load of >10,000 copies
  • Patients with an active infection that is currently being treated
  • Patients with history or confirmed metal allergy or foreign body sensitivity
  • Patients with a previous partial or full midline sternotomy
  • Patients with previous radiation treatment of the chest
  • 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

Exclusion Criteria: Operative

  • Patients requiring delayed sternotomy closure
  • Patients with transverse sternal fractures located beneath the cerclage band on the SternaLock 360 Device.
  • Patients presenting intra-operative conditions that in the opinion of the treating surgeon would require or preclude a specific method for sternal closure, or who are not able to be closed per the protocol.
  • Use of non resorbable (beeswax) bonewax along the sternotomy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

SternaLock 360
Experimental group
Description:
Sternal closure performed with SternaLock 360 as a primary closure system
Treatment:
Device: SternaLock 360
Wire Cerclage
Active Comparator group
Description:
Sternal closure performed with standard wire cerclage as a primary closure system
Treatment:
Device: Wire Cerclage

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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