Rigid Plate FixationRACE XPNCT05578651
A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP
An observational study of Rigid Plate Fixation and Median Sternotomy, run by Zimmer Biomet at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the post-operative rapid recovery in patients treated with SternaLock XP for rigid sternal fixation with sternal precautions less restrictive than standard of care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rigid Plate Fixation, Median Sternotomy
- What is being tested?
- SternaLock XP
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2024to Oct 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Received median sternotomy with rigid plate fixation after a cardiac procedure (e.g., valve replacement or repair, bypass grafting)
Who may be able to join
- Male and female
- ≥ 18 years of age, no upper limit
- Undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure [i.e., coronary artery bypass graft (CABG) and/ or valve replacement] and closed with the SternaLock XP Rigid Fixation System
- Willing to sign Informed Consent prior to the cardiac surgical procedure
- Willing and able to provide follow-up information up to 60-days post-operative
- Male and female
Show all 22Show fewer
- ≥ 18 years of age, no upper limit
- Undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure [i.e., coronary artery bypass graft (CABG) and/ or valve replacement] and closed with the SternaLock XP Rigid Fixation System
- Willing to sign Informed Consent prior to the cardiac surgical procedure
- Willing and able to provide follow-up information up to 60-days post-operative Exclusion Criteria
- Pre-operative
- Emergent or salvage cardiac acuity, i.e., patients undergoing cardiopulmonary resuscitation en-route to the operating room or prior to induction of anesthesia
- Active or latent infection (with positive culture)
- Documented foreign body sensitivity, allergy, or intolerance to metals.
- Rapid bone absorption condition, metabolic bone disease, cancer, tumor, or tumor like condition of the bone, end-stage malignant disease, or other unexplained disease.
- Mental/ neurologic conditions rendering patients unwilling or incapable of following post-operative care instructions.
- Functional disability affecting gait, balance or mobility.
- Operative
- Delayed sternal closure required for any reason (e.g., sent to ICU with open chest wound)
- Intra-operative conditions that, in the opinion of the operating surgeon, would preclude the use of rigid plate fixation.
- Insufficient quantity of sternal bone or limited blood supply as assessed by the operating surgeon using his or her professional judgment at the time of closure.
- Intraoperative death prior to device placement
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Catholic Medical Center
Manchester, New Hampshire, 03102
About this study
The primary objective of this study is to evaluate the post-operative rapid recovery in patients treated with SternaLock XP for rigid sternal fixation with sternal precautions less restrictive than standard of care.
Read the detailed description
The primary efficacy endpoint of evaluation is defined by the post-operative time back to prior work or life through patient diary.
The primary safety endpoint of evaluation is defined by the incidence rate of sternal complications (DSWI \& SSWI) at 30 days post-op.
The secondary endpoints of evaluation up to 60-days post-operative are defined by:
- Quality of recovery after surgery (QoR-15)
- Days alive out of the hospital and at home (DAH)
- Disability-free survival (WHODAS 2.0.)
- Pain scores: Likert scale 1-10
- Opioid pain medication usage
- Spirometry: inspiratory vital capacity (IVC), as a measure of lung function recovery
- Conditions
- Rigid Plate Fixation, Median Sternotomy
- Being tested
- SternaLock XP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SternaLock XPDevice
Plating system with cable cerclage bands that is used in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy
| Study group | Role | What they receive |
|---|---|---|
| SternaLock XP | Median sternotomy with rigid plate fixation (SternaLock XP) as the sole closure method Receives: Device: SternaLock XP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sternal wound infection
Rate of deep sternal wound infection and superficial sternal wound infection
Measured: 30 days
Secondary outcomes (6)
Quality of recovery after surgery
QoR-15 instrument
Measured: 60 days
Days alive and out of the hospital
Calculation of time
Measured: 60 days
Disability-free survival
WHODAS 2.0 instrument
Measured: 60 days
Pain score
Numerical Rating Pain Score
Measured: 60 days
Opioid medication usage
Milligrams of morphine equivalency administered
Measured: 60 days
Inspirometry vital capacity
Milliliters of spirometry capacity
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study startMar 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: Zimmer Biomet has no current plans to market this product in EMEA.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rigid Plate FixationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578651
- Sponsor's protocol ID
- 0821-02
- Acronym
- RACE XP
- Status last verified
- Jan 2025
- First submitted
- 11 Oct 2022
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP
- ClinicalTrials.gov ID
- NCT05578651
- Acronym / sponsor ID
- RACE XP / 0821-02
- Conditions
- Rigid Plate Fixation, Median Sternotomy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Zimmer Biomet has no current plans to market this product in EMEA.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Mar 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 13 Oct 2022 (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.
The primary objective of this study is to evaluate the post-operative rapid recovery in patients treated with SternaLock XP for rigid sternal fixation with sternal precautions less restrictive than standard of care.
Detailed description
The primary efficacy endpoint of evaluation is defined by the post-operative time back to prior work or life through patient diary.
The primary safety endpoint of evaluation is defined by the incidence rate of sternal complications (DSWI \& SSWI) at 30 days post-op.
The secondary endpoints of evaluation up to 60-days post-operative are defined by:
- Quality of recovery after surgery (QoR-15)
- Days alive out of the hospital and at home (DAH)
- Disability-free survival (WHODAS 2.0.)
- Pain scores: Likert scale 1-10
- Opioid pain medication usage
- Spirometry: inspiratory vital capacity (IVC), as a measure of lung function recovery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SternaLock XP | – | Device: SternaLock XPMedian sternotomy with rigid plate fixation (SternaLock XP) as the sole closure method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Received median sternotomy with rigid plate fixation after a cardiac procedure (e.g., valve replacement or repair, bypass grafting)
Key inclusion criteria (22 listed)
- Male and female
- ≥ 18 years of age, no upper limit
- Undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure [i.e., coronary artery bypass graft (CABG) and/ or valve replacement] and closed with the SternaLock XP Rigid Fixation System
- Willing to sign Informed Consent prior to the cardiac surgical procedure
- Willing and able to provide follow-up information up to 60-days post-operative
Key exclusion criteria (0 listed)
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 XPPlating system with cable cerclage bands that is used in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy | Device | SternaLock XP |
Primary outcome
Incidence of sternal wound infection
Time frame: 30 days
Rate of deep sternal wound infection and superficial sternal wound infection
6 secondary outcomes
Quality of recovery after surgery
Time frame: 60 days
Days alive and out of the hospital
Time frame: 60 days
Disability-free survival
Time frame: 60 days
Pain score
Time frame: 60 days
Opioid medication usage
Time frame: 60 days
Inspirometry vital capacity
Time frame: 60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rigid Plate Fixation and Median Sternotomy, run by Zimmer Biomet 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?
The sponsor lists 22 inclusion and 0 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: withdrawn, as of the sponsor's last update on 16 Jan 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of sternal wound infection (time frame: 30 days). 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 16 Jan 2025.