Clinical trials: Sternal Closure
Sternum Wound Infection, Nonunion of Fracture of Sternum
Sternal Closure With STERNUMFIX in Patients With High Risk
The primary objective is to establish if the SternumFix System improves sternal closure. The study should test the hypothesis that in a high risk patient population with increased risk for the development of sternal wound…
- Trial name
- STEPHIX (NCT01408745)
- Testing
- Sternumfix, steel wire
- Where
- 4 sites in Germany, Switzerland
- Volunteers
- 166 people
- Sponsor
- Aesculap AG
Median Sternotomy
RCT to Evaluate STERN FIX Device as a Sternal Stabilization System in Patients After Sternotomy
The goal of this clinical trial is to compare the safety and performance of the sternal stabilization system STERN FIX with the standard of care (sternal closure with wires only) in normal conditions of use, in patients of risk…
- Trial name
- FIXTER-2 (NCT05953259)
- Testing
- Combination of STERN FIX and wires, Wires
- Where
- 5 sites in Germany, Spain
- Volunteers
- 90 people
- Sponsor
- NEOS Surgery
Sternotomy Closure,Open Heart Surgery
Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure
The goal of this clinical trial is to learn if a new medical device (SC03 plates) to close the sternum after a sternotomy in patients that have been operated of a cardiac surgery, is safe and effective.
- Trial name
- FIX IT ALL (NCT07366203)
- Testing
- SC03 Plating system, Stainless steel wires
- Volunteers
- 190 people
- Sponsor
- NEOS Surgery
Sternal Fracture
Sternal Closure With SternaLock 360: First in Man Study
The SternaLock 360 Sternal Closure Device combines the techniques of rigid fixation with a cerclage material into a single sternal closure system.
- Trial name
- SL360 (NCT02686099)
- Testing
- SternaLock 360, Wire Cerclage
- Where
- South Africa
- Volunteers
- 50 people
- Sponsor
- Zimmer Biomet
Post Cardiac Surgery, Sternal Closure
TORQ Clinical Study
The proposed trial is to evaluate the use of the TORQ closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires.
- Trial name
- TORQClin (NCT01647178)
- Testing
- TORQ assisted sternal closure, Conventional closure
- Where
- Canada
- Volunteers
- 92 people
- Sponsor
- Kardium Inc.
Coronary Artery Disease, Cardiac Valve Insufficiency
Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure.
- Conditions
- Coronary Artery Disease, Cardiac Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- STERCCAS (NCT05439395)
- Testing
- Sternum Closure after Cardiac Surgery
- Where
- 2 sites in Germany, Spain
- Volunteers
- 229 people
- Sponsor
- Aesculap AG
Sternotomy
Sternal Fixation With STERN FIX After Medial Sternotomy
The goal of this single arm observational registry is to evaluate the safety and performance of the STERN FIX device in normal conditions of use, in patients treated with medial sternotomy according to the instructions for use.
- Trial name
- NCT05784532
- Testing
- STERN FIX
- Where
- United States
- Sponsor
- NEOS Surgery
Retrospective Review, Cerclage
Enhanced Sternal Closure With Montage or Montage-CT to Evaluate Post-Operative Opioid Use Following Median Sternotomy
This is a retrospective study based on analysis real world data obtained from hospitals that have adopted use of Montage or Montage-CT for use following sternotomy.
- Conditions
- Retrospective Review, Cerclage, Pain Management
- Trial name
- NCT07215546
- Testing
- Montage or Montage CT
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- Abyrx, Inc.
Coronary Artery Disease, Angina Pectoris
An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery
The primary objective of this study is to evaluate sternal bone healing following a full median sternotomy versus standard of care for sternal closure with wire cerclage.
- Conditions
- Coronary Artery Disease, Angina Pectoris, Cardiac Valve Disease
- Trial name
- SB (NCT01783483)
- Testing
- SternaLock Blue closure system, Suture Wire
- Where
- 12 sites in United States
- Volunteers
- 236 people
- Sponsor
- Zimmer Biomet