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Completed

NCT Number: NCT02686099

Sternal Closure With SternaLock 360: First in Man Study

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.

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Key information

Conditions

Sternal Fracture

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groote Schuur Hospital

Cape Town, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SternaLock 360

Device

Sternal closure with SternaLock 360

Wire Cerclage

Device

Sternal closure with standard wire cerclage

Primary outcomes

  1. Sternal Bone Healing

    Time frame: 6 months

    Sternal bone healing score as defined by CT scan assessment at 6 months postoperatively

Secondary outcomes

  1. Sternal Pain

    Time frame: Baseline, postoperative day 3 to day 7, 1-month post-op, 3-month post-op and 6-month post-op

    Pain scores obtained at pre-specified time points in 4 modalities: at rest, after using incentive spirometer, after ambulation and after forced coughing. Likert scale questionnaire.

  2. Analgesic usage

    Time frame: Baseline, postoperative day 0 to day 7, 1-month post-op, 3-month post-op and 6-month post-op

    Tabulation of all pain medication administered in pre-specified time points

  3. Upper Extremities Functional Status

    Time frame: Baseline, 1-month post-op, 3-month post-op and 6-month post-op

    Functional status of upper extremities are evaluated using 20 items that are rated on a 5-point Likert scale known as Upper Extremity Functional Index questionnaire.

  4. Return to Work

    Time frame: Baseline, 1-month post-op, 3-month post-op and 6-month post-op

    Assessment of working status of patients before and after cardiac surgery using 7-categorical question questionnaire.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Collaborators

  • University of Cape Town

Registry information

Official study title

SternaLock 360 First in Man Study: A Prospective, Randomized Controlled Trial

Acronym: SL360

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Feb 19, 2016
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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