CompletedNot Applicable

Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain

United States, Germany140 participantsStarted 2008-11

Plain-language summary

The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients undergoing median sternotomy; * Patients eighteen (18) years of age or older; * Patients presenting two or more risk factors such as diabetes mellitus, Chronic Obstructive Pulmonary Disease, obesity (BMI \> 30), osteoporosis, Renal failure, Chronic steroid use, Immunosuppression, Redo sternotomy, Neurologic dysfunction severely affecting ambulation, * Off mid-line sternotomy * bilateral IMA use * Long cardio-pulmonary bypass runs * Transverse fractures of the sternum Exclusion Criteria: * Patients with a non-standard sternotomy; * Patients with an off-midline sternotomy that reduced the bony margin to \<2mm * Patients under eighteen (18) years of age; * Patients that are pregnant or currently lactating; * Patients presenting intra-operative conditions that would require the use of rigid fixation and/or additional post-sternotomy mechanical support beyond wire cerclage due to surgical evaluation, * Patients defined within the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) functional Class IV for congestive heart failure, * 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; * Patients undergoing post-operative revision procedures that treat the original sternotomy in such a way as to affect outcome (antibiotic irrigation, debride…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

CT Scan Evaluation of Sternal Bone Healing

Timeframe: 3 and 6 Months

Activity Based Total Visual Analog Pain Score

Timeframe: 6 months

Trial details

NCT IDNCT00819286

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-01

Results submitted2011-12-27

View on ClinicalTrials.gov More Sternal Wound Infection trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.