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

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ClinicalTrials.gov Identifier: NCT02686099
Recruitment Status : Completed
First Posted : February 19, 2016
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
University of Cape Town
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sternal Fracture Device: SternaLock 360 Device: Wire Cerclage Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparison of intervention using sternal closure with 360 plating system, to closure of the sternum using wire cerclage
Masking: Single (Participant)
Masking Description: participants are blinded to treatment choice until completion of the study.
Primary Purpose: Treatment
Official Title: SternaLock 360 First in Man Study: A Prospective, Randomized Controlled Trial
Actual Study Start Date : July 4, 2015
Actual Primary Completion Date : September 5, 2017
Actual Study Completion Date : January 15, 2018

Arm Intervention/treatment
Experimental: SternaLock 360
Sternal closure performed with SternaLock 360 as a primary closure system
Device: SternaLock 360
Sternal closure with SternaLock 360

Active Comparator: Wire Cerclage
Sternal closure performed with standard wire cerclage as a primary closure system
Device: Wire Cerclage
Sternal closure with standard wire cerclage




Primary Outcome Measures :
  1. Sternal Bone Healing [ Time Frame: 6 months ]
    Sternal bone healing score as defined by CT scan assessment at 6 months postoperatively


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686099


Locations
South Africa
Groote Schuur Hospital
Cape Town, South Africa
Sponsors and Collaborators
Zimmer Biomet
University of Cape Town
Investigators
Study Director: Brian M Hatcher, PhD Zimmer Biomet

Additional Information:
Publications:

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02686099     History of Changes
Other Study ID Numbers: 0614
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zimmer Biomet:
Rigid Fixation
Sternal Plating
Sternal Closure
Sternalock