Heart DiseasesNCT06660186
Sternal Plating High Risk
A study testing Rigid Sternal Fixation and Wire Cerclage in people with Heart Diseases, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Participants are being invited to participate in a research study at University Hospitals because they have heart disease and are scheduled for open heart surgery. Currently, UH cardiac surgeons close the sternum (or breastbone) after a sternotomy (procedure that allows a doctor to reach the heart and blood vessels)… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Rigid Sternal Fixation and Wire Cerclage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Preoperative Inclusion Criteria
- Adults (age range: 18-89)
- Undergoing cardiac surgery through sternotomy -≥2 risk factors:
- Diabetes mellitus
- Severe COPD
- Chronic steroid use
- Immunosuppression
- Redo sternotomy
- Chronic
- Kidney disease with GFR >30 ml/min per 1.73m2
- Radiation therapy
- BMI≥35
- High-risk of delirium
- Heavy alcohol use
Preoperative Exclusion Criteria
- Active malignancy
- Chronic narcotic use
- NYHA Class IV
- Known nickel metal allergy
- Compliance concern
- eGFR<30 ml/min per 1.73m2
- Involvement in another interventional clinical trial (non-registry)
- Any criteria precluding RPF or WC
Operative Inclusion Criteria
- Off-midline sternotomy
- BITA grafting
- CPB time ≥120 minutes
- Transverse sternal fracture
Operative Exclusion Criteria
- Emergent or emergent salvage surgery
- Non-standard sternotomies
- Sternotomy with bony margin <2 mm
- Bleeding
- Delayed sternal closure
- Surgical complications
- Any criteria precluding RPF or WC
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals
Cleveland, Ohio, 44106
Stacey Mazzurco, 216-844-3130, Stacey.Mazzurco@UHhospitals.org
About this study
Official title: Randomized Trial of Rigid Plate Fixation Versus Wire Cerclage in High-Risk Sternotomy Patients
Participants are being invited to participate in a research study at University Hospitals because they have heart disease and are scheduled for open heart surgery. Currently, UH cardiac surgeons close the sternum (or breastbone) after a sternotomy (procedure that allows a doctor to reach the heart and blood vessels) with either a rigid plate fixation Sternal Plate or a Wire Cerclage. However, the study team would like to further evaluate these two techniques. Any volunteer over the age of 18 who is at an increased risk for developing sternal wound complications may be eligible to participate.
- Conditions
- Heart Diseases
- Being tested
- Rigid Sternal Fixation, Wire Cerclage
- Keywords
- Cardiac Surgery, Wound Complication, Rigid Sternal Fixation, Sternal Infection, Pain, Non-union
- Medical subject headings
- Heart Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rigid Sternal FixationDevice
The surgeon will close the sternum (breastbone) using the SternalPlate system. The SternalPlate System consists of implants and instruments used to hold the two halves of the sternum together.
Wire CerclageDevice
The surgeon will close the sternum (breastbone) using Wire Cerclage. Wire Cerclage consists of stainless steel wires used to hold the two halves of your sternum together.
| Study group | Role | What they receive |
|---|---|---|
| Rigid Sternal Fixation | Experimental | The surgeon will close the sternum (breastbone) using the SternalPlate system. The SternalPlate System consists of implants and instruments used to hold the two halves of the sternum together. Receives: Device: Rigid Sternal Fixation |
| Wire Cerclage | Active comparator | The surgeon will close the sternum (breastbone) using Wire Cerclage. Wire Cerclage consists of stainless steel wires used to hold the two halves of the sternum together. Receives: Device: Wire Cerclage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sternal healing as measured by CT scan
5 axial CT slices from a priori-defined anatomic locations are selected by a radiologist. Two additional radiologists then independently score each location using a 6-point scale (0, 1, 2, 3, 4, or 5) with higher scores representing greater healing. Sternal union will be pre-specified as a mean score ≥3 (total score ≥15).
Measured: 6 months
Number of sternal wound complications as measured by patient/physician report
Sternal wound complications will be a composite of wound dehiscence, sternal dehiscence, SSIs, and DSWIs (synonymous with deep SSIs and mediastinitis).
Measured: 6 months
Total index hospitalization cost
Index hospitalization costs (beginning at the time of surgery and ending at initial discharge)
Measured: 6 months
Total cost
All costs after initial discharge through 6 months
Measured: 6 months
Secondary outcomes (5)
Change in pain as measured by the Wong-Baker pain scale
From a scale of 0 (no hurts) to 10 (hurts worst)
Measured: Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months
Change in prescribed narcotic use as measured by patient report
Evaluating mean morphine equivalent
Measured: Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months
Change in upper extremity functional index (UEFI)
The UEFI is a validated 20 item questionnaire used for quantifying UEF in performing normal daily activities.
Measured: Discharge (up to 10 days), 1 month, 6 months
Change in quality of life as measured by the EuroQol EQ-5D-5L
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: Discharge (up to 10 days), 1 month, 6 months
Number of adverse events as measured by patient report
Adverse events of interest not specified above include: damage to soft tissue, organs, or surrounding structures during closure, need for reoperation, loosening of the wires, screws, or plates, fracture of the wires, screws, or plates, and need for hardware removal (wires, screws, or plates).
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start12 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Responsible party
- Sponsor
- Investigators
- Marc Pelletier, MD, Principal investigator, University HospitalsRakesh Arora, MD, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660186
- Sponsor's protocol ID
- STUDY20240513
- Status last verified
- Apr 2026
- First submitted
- 23 Oct 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Rigid Plate Fixation Versus Wire Cerclage in High-Risk Sternotomy Patients
- ClinicalTrials.gov ID
- NCT06660186
- Acronym / sponsor ID
- STUDY20240513
- Conditions
- Heart Diseases
- Keywords
- Cardiac Surgery, Wound Complication, Rigid Sternal Fixation, Sternal Infection, Pain, Non-union
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Oct 2024 (actual)
- 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.
Participants are being invited to participate in a research study at University Hospitals because they have heart disease and are scheduled for open heart surgery. Currently, UH cardiac surgeons close the sternum (or breastbone) after a sternotomy (procedure that allows a doctor to reach the heart and blood vessels) with either a rigid plate fixation Sternal Plate or a Wire Cerclage. However, the study team would like to further evaluate these two techniques. Any volunteer over the age of 18 who is at an increased risk for developing sternal wound complications may be eligible to participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rigid Sternal Fixation | Experimental | Device: Rigid Sternal FixationThe surgeon will close the sternum (breastbone) using the SternalPlate system. The SternalPlate System consists of implants and instruments used to hold the two halves of the sternum together. |
| Wire Cerclage | Active comparator | Device: Wire CerclageThe surgeon will close the sternum (breastbone) using Wire Cerclage. Wire Cerclage consists of stainless steel wires used to hold the two halves of the sternum together. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Rigid Sternal FixationThe surgeon will close the sternum (breastbone) using the SternalPlate system. The SternalPlate System consists of implants and instruments used to hold the two halves of the sternum together. | Device | Rigid Sternal Fixation |
| Wire CerclageThe surgeon will close the sternum (breastbone) using Wire Cerclage. Wire Cerclage consists of stainless steel wires used to hold the two halves of your sternum together. | Device | Wire Cerclage |
Primary outcome
Sternal healing as measured by CT scan
Time frame: 6 months
5 axial CT slices from a priori-defined anatomic locations are selected by a radiologist. Two additional radiologists then independently score each location using a 6-point scale (0, 1, 2, 3, 4, or 5) with higher scores representing greater healing. Sternal union will be pre-specified as a mean score ≥3 (total score ≥15).
Number of sternal wound complications as measured by patient/physician report
Time frame: 6 months
Sternal wound complications will be a composite of wound dehiscence, sternal dehiscence, SSIs, and DSWIs (synonymous with deep SSIs and mediastinitis).
Total index hospitalization cost
Time frame: 6 months
Index hospitalization costs (beginning at the time of surgery and ending at initial discharge)
Total cost
Time frame: 6 months
All costs after initial discharge through 6 months
5 secondary outcomes
Change in pain as measured by the Wong-Baker pain scale
Time frame: Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months
Change in prescribed narcotic use as measured by patient report
Time frame: Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months
Change in upper extremity functional index (UEFI)
Time frame: Discharge (up to 10 days), 1 month, 6 months
Change in quality of life as measured by the EuroQol EQ-5D-5L
Time frame: Discharge (up to 10 days), 1 month, 6 months
Number of adverse events as measured by patient report
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Marc Pelletier, MD principal investigator
University Hospitals
Rakesh Arora, MD principal investigator
University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rigid Sternal Fixation and Wire Cerclage in people with Heart Diseases, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacey Mazzurco (216-844-3130, Stacey.Mazzurco@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sternal healing as measured by CT scan (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2026.