Clinical trial NCT02686099: Sternal Closure With SternaLock 360: First in Man Study
Official title: SternaLock 360 First in Man Study: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sternal Fracture
Keywords: Rigid Fixation
Sternal Plating
Sternal Closure
Sternalock
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: University of Cape Town
First posted: 2016-02-19
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of intervention using sternal closure with 360 plating system, to closure of the sternum using wire cerclage
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Sternal Bone Healing
timeFrame: 6 months
Secondary outcomes:
measure: Sternal Pain
timeFrame: Baseline, postoperative day 3 to day 7, 1-month post-op, 3-month post-op and 6-month post-op
measure: Analgesic usage
timeFrame: Baseline, postoperative day 0 to day 7, 1-month post-op, 3-month post-op and 6-month post-op
measure: Upper Extremities Functional Status
timeFrame: Baseline, 1-month post-op, 3-month post-op and 6-month post-op
measure: Return to Work
timeFrame: Baseline, 1-month post-op, 3-month post-op and 6-month post-op
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
Study officials:
affiliation: Zimmer Biomet
name: Brian M Hatcher, PhD
role: STUDY_DIRECTOR
References:
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