Sternal FractureSL360NCT02686099

Sternal Closure With SternaLock 360: First in Man Study

A study testing SternaLock 360 and Wire Cerclage in people with Sternal Fracture, run by Zimmer Biomet at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 years and older
Conditions the study is for: Sternal Fracture
What is being tested?: SternaLock 360 and Wire Cerclage
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteSouth Africa
Study dates: 4 Jul 2015to 15 Jan 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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
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 locations and contacts

1 site in 1 country.

South Africa1 site

Groote Schuur Hospital
Cape Town

Other trials in South Africa

About this study

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

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.

Read the 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.

Conditions: Sternal Fracture
Being tested: SternaLock 360, Wire Cerclage
Keywords: Rigid Fixation, Sternal Plating, Sternal Closure, Sternalock

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SternaLock 360Device
Sternal closure with SternaLock 360
Wire CerclageDevice
Sternal closure with standard wire cerclage

Study groups in NCT02686099
Study group	Role	What they receive
SternaLock 360	Experimental	Sternal closure performed with SternaLock 360 as a primary closure system Receives: Device: SternaLock 360
Wire Cerclage	Active comparator	Sternal closure performed with standard wire cerclage as a primary closure system Receives: Device: Wire Cerclage

What is being measured

The primary outcome is the main question the study is designed to answer.

Sternal Bone Healing
Sternal bone healing score as defined by CT scan assessment at 6 months postoperatively
Measured: 6 months

Secondary outcomes (4)

Sternal Pain
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.
Measured: Baseline, postoperative day 3 to day 7, 1-month post-op, 3-month post-op and 6-month post-op
Analgesic usage
Tabulation of all pain medication administered in pre-specified time points
Measured: Baseline, postoperative day 0 to day 7, 1-month post-op, 3-month post-op and 6-month post-op
Upper Extremities Functional Status
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.
Measured: Baseline, 1-month post-op, 3-month post-op and 6-month post-op
Return to Work
Assessment of working status of patients before and after cardiac surgery using 7-categorical question questionnaire.
Measured: Baseline, 1-month post-op, 3-month post-op and 6-month post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jul 201515 Jan 2018

First posted19 Feb 2016 (estimated)
Study start4 Jul 2015
Primary completion5 Sep 2017
Study completion15 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Sternal FractureStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Comparison of intervention using sternal closure with 360 plating system, to closure of the sternum using wire cerclage
Masking: Single blind
Who is masked: Participant
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02686099
Sponsor's protocol ID: 0614
Acronym: SL360
Status last verified: Jan 2018
First submitted: 9 Feb 2016
Last updated: 18 Jan 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Casha AR, Yang L, Kay PH, Saleh M, Cooper GJ. A biomechanical study of median sternotomy closure techniques. Eur J Cardiothorac Surg. 1999 Mar;15(3):365-9. doi: 10.1016/s1010-7940(99)00014-7.
PubMed 10333037
Cohen DJ, Griffin LV. A biomechanical comparison of three sternotomy closure techniques. Ann Thorac Surg. 2002 Feb;73(2):563-8. doi: 10.1016/s0003-4975(01)03389-6.
PubMed 11845875
Hirose H, Yamane K, Youdelman BA, Bogar L, Diehl JT. Rigid sternal fixation improves postoperative recovery. Open Cardiovasc Med J. 2011;5:148-52. doi: 10.2174/1874192401105010148. Epub 2011 Jul 4.
PubMed 21760857
Lahtinen P, Kokki H, Hynynen M. Pain after cardiac surgery: a prospective cohort study of 1-year incidence and intensity. Anesthesiology. 2006 Oct;105(4):794-800. doi: 10.1097/00000542-200610000-00026.
PubMed 17006079
Losanoff JE, Basson MD, Gruber SA, Huff H, Hsieh FH. Single wire versus double wire loops for median sternotomy closure: experimental biomechanical study using a human cadaveric model. Ann Thorac Surg. 2007 Oct;84(4):1288-93. doi: 10.1016/j.athoracsur.2007.05.023.
PubMed 17888985
Losanoff JE, Collier AD, Wagner-Mann CC, Richman BW, Huff H, Hsieh Fh, Diaz-Arias A, Jones JW. Biomechanical comparison of median sternotomy closures. Ann Thorac Surg. 2004 Jan;77(1):203-9. doi: 10.1016/s0003-4975(03)01468-1.
PubMed 14726062
Meyerson J, Thelin S, Gordh T, Karlsten R. The incidence of chronic post-sternotomy pain after cardiac surgery--a prospective study. Acta Anaesthesiol Scand. 2001 Sep;45(8):940-4. doi: 10.1034/j.1399-6576.2001.450804.x.
PubMed 11576043
Pai S, Gunja NJ, Dupak EL, McMahon NL, Coburn JC, Lalikos JF, Dunn RM, Francalancia N, Pins GD, Billiar KL. A mechanical study of rigid plate configurations for sternal fixation. Ann Biomed Eng. 2007 May;35(5):808-16. doi: 10.1007/s10439-007-9272-3. Epub 2007 Mar 22.
PubMed 17377844
Raman J, Lehmann S, Zehr K, De Guzman BJ, Aklog L, Garrett HE, MacMahon H, Hatcher BM, Wong MS. Sternal closure with rigid plate fixation versus wire closure: a randomized controlled multicenter trial. Ann Thorac Surg. 2012 Dec;94(6):1854-61. doi: 10.1016/j.athoracsur.2012.07.085. Epub 2012 Oct 25.
PubMed 23103010
Raman J, Song DH, Bolotin G, Jeevanandam V. Sternal closure with titanium plate fixation--a paradigm shift in preventing mediastinitis. Interact Cardiovasc Thorac Surg. 2006 Aug;5(4):336-9. doi: 10.1510/icvts.2005.121863. Epub 2006 Apr 25.
PubMed 17670585
Sargent LA, Seyfer AE, Hollinger J, Hinson RM, Graeber GM. The healing sternum: a comparison of osseous healing with wire versus rigid fixation. Ann Thorac Surg. 1991 Sep;52(3):490-4. doi: 10.1016/0003-4975(91)90910-i.
PubMed 1898136
Schimmer C, Reents W, Berneder S, Eigel P, Sezer O, Scheld H, Sahraoui K, Gansera B, Deppert O, Rubio A, Feyrer R, Sauer C, Elert O, Leyh R. Prevention of sternal dehiscence and infection in high-risk patients: a prospective randomized multicenter trial. Ann Thorac Surg. 2008 Dec;86(6):1897-904. doi: 10.1016/j.athoracsur.2008.08.071.
PubMed 19022005
Song DH, Lohman RF, Renucci JD, Jeevanandam V, Raman J. Primary sternal plating in high-risk patients prevents mediastinitis. Eur J Cardiothorac Surg. 2004 Aug;26(2):367-72. doi: 10.1016/j.ejcts.2004.04.038.
PubMed 15296898

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SternaLock 360 First in Man Study: A Prospective, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02686099
Acronym / sponsor ID: SL360 / 0614
Conditions: Sternal Fracture
Keywords: Rigid Fixation, Sternal Plating, Sternal Closure, Sternalock
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Collaborators: University of Cape Town
Study start: 4 Jul 2015 (actual)
Primary completion: 5 Sep 2017 (actual)
Study completion: 15 Jan 2018 (actual)
First posted: 19 Feb 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Comparison of intervention using sternal closure with 360 plating system, to closure of the sternum using wire cerclage

Arm	Type	Receives
SternaLock 360	Experimental	Device: SternaLock 360Sternal closure performed with SternaLock 360 as a primary closure system
Wire Cerclage	Active comparator	Device: Wire CerclageSternal closure performed with standard wire cerclage as a primary closure system

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SternaLock 360Sternal closure with SternaLock 360	Device	SternaLock 360
Wire CerclageSternal closure with standard wire cerclage	Device	Wire Cerclage

Primary outcome

Sternal Bone Healing
Time frame: 6 months
Sternal bone healing score as defined by CT scan assessment at 6 months postoperatively

4 secondary outcomes

Sternal Pain
Time frame: Baseline, postoperative day 3 to day 7, 1-month post-op, 3-month post-op and 6-month post-op
Analgesic usage
Time frame: Baseline, postoperative day 0 to day 7, 1-month post-op, 3-month post-op and 6-month post-op
Upper Extremities Functional Status
Time frame: Baseline, 1-month post-op, 3-month post-op and 6-month post-op
Return to Work
Time frame: Baseline, 1-month post-op, 3-month post-op and 6-month post-op

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
Background: PubMed 10333037Casha AR, Yang L, Kay PH, Saleh M, Cooper GJ. A biomechanical study of median sternotomy closure techniques. Eur J Cardiothorac Surg. 1999 Mar;15(3):365-9. doi: 10.1016/s1010-7940(99)00014-7.
Background: PubMed 11845875Cohen DJ, Griffin LV. A biomechanical comparison of three sternotomy closure techniques. Ann Thorac Surg. 2002 Feb;73(2):563-8. doi: 10.1016/s0003-4975(01)03389-6.
Background: PubMed 21760857Hirose H, Yamane K, Youdelman BA, Bogar L, Diehl JT. Rigid sternal fixation improves postoperative recovery. Open Cardiovasc Med J. 2011;5:148-52. doi: 10.2174/1874192401105010148. Epub 2011 Jul 4.
Background: PubMed 17006079Lahtinen P, Kokki H, Hynynen M. Pain after cardiac surgery: a prospective cohort study of 1-year incidence and intensity. Anesthesiology. 2006 Oct;105(4):794-800. doi: 10.1097/00000542-200610000-00026.
Background: PubMed 17888985Losanoff JE, Basson MD, Gruber SA, Huff H, Hsieh FH. Single wire versus double wire loops for median sternotomy closure: experimental biomechanical study using a human cadaveric model. Ann Thorac Surg. 2007 Oct;84(4):1288-93. doi: 10.1016/j.athoracsur.2007.05.023.
Background: PubMed 14726062Losanoff JE, Collier AD, Wagner-Mann CC, Richman BW, Huff H, Hsieh Fh, Diaz-Arias A, Jones JW. Biomechanical comparison of median sternotomy closures. Ann Thorac Surg. 2004 Jan;77(1):203-9. doi: 10.1016/s0003-4975(03)01468-1.
Background: PubMed 11576043Meyerson J, Thelin S, Gordh T, Karlsten R. The incidence of chronic post-sternotomy pain after cardiac surgery--a prospective study. Acta Anaesthesiol Scand. 2001 Sep;45(8):940-4. doi: 10.1034/j.1399-6576.2001.450804.x.
Background: PubMed 17377844Pai S, Gunja NJ, Dupak EL, McMahon NL, Coburn JC, Lalikos JF, Dunn RM, Francalancia N, Pins GD, Billiar KL. A mechanical study of rigid plate configurations for sternal fixation. Ann Biomed Eng. 2007 May;35(5):808-16. doi: 10.1007/s10439-007-9272-3. Epub 2007 Mar 22.
Background: PubMed 23103010Raman J, Lehmann S, Zehr K, De Guzman BJ, Aklog L, Garrett HE, MacMahon H, Hatcher BM, Wong MS. Sternal closure with rigid plate fixation versus wire closure: a randomized controlled multicenter trial. Ann Thorac Surg. 2012 Dec;94(6):1854-61. doi: 10.1016/j.athoracsur.2012.07.085. Epub 2012 Oct 25.
Background: PubMed 17670585Raman J, Song DH, Bolotin G, Jeevanandam V. Sternal closure with titanium plate fixation--a paradigm shift in preventing mediastinitis. Interact Cardiovasc Thorac Surg. 2006 Aug;5(4):336-9. doi: 10.1510/icvts.2005.121863. Epub 2006 Apr 25.
Background: PubMed 1898136Sargent LA, Seyfer AE, Hollinger J, Hinson RM, Graeber GM. The healing sternum: a comparison of osseous healing with wire versus rigid fixation. Ann Thorac Surg. 1991 Sep;52(3):490-4. doi: 10.1016/0003-4975(91)90910-i.
Background: PubMed 19022005Schimmer C, Reents W, Berneder S, Eigel P, Sezer O, Scheld H, Sahraoui K, Gansera B, Deppert O, Rubio A, Feyrer R, Sauer C, Elert O, Leyh R. Prevention of sternal dehiscence and infection in high-risk patients: a prospective randomized multicenter trial. Ann Thorac Surg. 2008 Dec;86(6):1897-904. doi: 10.1016/j.athoracsur.2008.08.071.
STS Adult Cardiac Surgery Database Risk Model VariablesLink provided by the sponsor.
"Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain (RESTORE).Link provided by the sponsor.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brian M Hatcher, PhD study director

Zimmer Biomet

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SternaLock 360 and Wire Cerclage in people with Sternal Fracture, run by Zimmer Biomet at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sternal Bone Healing (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02686099, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.