An interventional study of SternaLock Rigid Fixation Plates and wire (control) in Sternal Wound Infection, Sternal Non-union and Pain, sponsored by Zimmer Biomet. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-13.
Sponsored by Zimmer Biomet · Not applicable, Interventional, and Treatment
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.
Median sternotomy patients will be randomized to either wire or rigid fixation groups. A scheduled evaluation period will record clinical parameters. Enrollment has ended with one hundred forty (140) patients.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 140 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients will have their sternum closed using wire (stainless steel surgical wire).
Device: wire (control)
patients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates.
Device: SternaLock Rigid Fixation Plates
patients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates
patients will have their sternum closed using wire (stainless steel surgical wire).
CT Scan Evaluation of Sternal Bone Healing
Quantitative evaluation of sternal bone healing at 5 anatomical locations along the sternum using a 6 point quantitative scale (0= no healing and 5= complete healing)
Time frame: 3 and 6 Months
Activity Based Total Visual Analog Pain Score
Postoperative VAS pain scores (scale of 0-10 for each; 0= no pain, 10= worst pain imaginable) were evaluated as a function of resting, coughing, sneezing and general movement. The sum of these was used to derive an "Activity Based Total Visual Analog Pain Score", (scale of 0-40; 0= no pain, 40= worst pain imaginable). For this primary endpoint analysis, the total score at 6 months was evaluated.
Time frame: 6 months
Prospective, randomized trial at 5 US sites and 1 European site. Patient enrollment occurred between November 2008 and May 2010.
| Milestone | Wire (Control) | Plates |
|---|---|---|
| Started | 70 | 70 |
| Completed | 56 | 45 |
| Not completed | 14 | 25 |
Quantitative evaluation of sternal bone healing at 5 anatomical locations along the sternum using a 6 point quantitative scale (0= no healing and 5= complete healing)
| units on a scale | Wire (Control) | Plates |
|---|---|---|
| 3 Month CT Scan (n=25 wire, n=27 plates) | 0.9 ± 0.8 | 1.7 ± 1.1 |
| 6 Month CT Scan (n=26 wire, n=23 plates) | 2.2 ± 1.1 | 3.2 ± 1.6 |
Postoperative VAS pain scores (scale of 0-10 for each; 0= no pain, 10= worst pain imaginable) were evaluated as a function of resting, coughing, sneezing and general movement. The sum of these was used to derive an "Activity Based Total Visual Analog Pain Score", (scale of 0-40; 0= no pain, 40= worst pain imaginable). For this primary endpoint analysis, the total score at 6 months was evaluated.
| units on a scale | Wire (Control) | Plates |
|---|---|---|
| Activity Based Total Visual Analog Pain Score | 7.28 ± 4.65 | 7.20 ± 4.04 |
Collected over 0 to 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Wire (Control) | — | 24/70 (34.3%) | 20/70 (28.6%) |
| Plates | — | 32/70 (45.7%) | 24/70 (34.3%) |
| Event | Wire (Control) | Plates |
|---|---|---|
| ResternotomySurgical and medical procedures | 7/70 | 11/70 |
| Cardiac arrestCardiac disorders | 2/70 | 3/70 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/70 | 3/70 |
| Respiratory insufficiencyRespiratory, thoracic and mediastinal disorders | 3/70 | 2/70 |
| Cardiac arrhythmiasCardiac disorders | 2/70 | 2/70 |
| Low cardiac outputCardiac disorders | 2/70 | 0/70 |
| GI BleedGastrointestinal disorders | 0/70 | 2/70 |
| StrokeNervous system disorders | 2/70 | 1/70 |
| Acute renal failureRenal and urinary disorders | 2/70 | 2/70 |
| AnemiaBlood and lymphatic system disorders | 1/70 | 1/70 |
| Event | Wire (Control) | Plates |
|---|---|---|
| Cardiac arrhythmiasCardiac disorders | 9/70 | 12/70 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 10/70 | 8/70 |
| Acute renal failureRenal and urinary disorders | 1/70 | 4/70 |
| Age, Continuous(years) | Wire (Control) | Plates | Total |
|---|---|---|---|
| Mean | 64.0 ± 8.9 | 66.3 ± 9.8 | 65.2 ± 9.4 |
| Sex: Female, Male(Participants) | Wire (Control) | Plates | Total |
|---|---|---|---|
| Female | 18 | 19 | 37 |
| Male | 52 | 51 | 103 |
The record gives a start of Nov 2008, a primary completion of Jan 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2012, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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