Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain

Pain Clinical Trial

— RESTORE  

Official title:

A Prospective, Randomized-Controlled, Multicenter Study Evaluating Primary Plating in High-Risk Median Sternotomy Patients for Osteosynthesis and Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819286
• Other study ID #: 07071
• Status: Completed
• Phase: N/A
• First received: January 6, 2009
• Last updated: January 16, 2018
• Start date: November 2008
• Est. completion date: December 2011

Study information

• Verified date: January 2018
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, debridement or other treatment to the osteotomy);

• Patients unwilling or unable to return for follow-up;

• Lacking the ability to follow instructions;

• Intraoperative death.

Related Conditions & MeSH terms

• Mediastinitis
• Pain
• Sternal Non-union
• Sternal Wound Infection
• Wound Infection

Intervention

Device:
• SternaLock Rigid Fixation Plates
patients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates
• wire (control)
patients will have their sternum closed using wire (stainless steel surgical wire).

Locations

Country	Name	City	State
Germany	Leipzig Heart Center	Leipzig
United States	University of Chicago	Chicago	Illinois
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	St. Joseph's Heart and Lung Institute	Phoenix	Arizona
United States	University of California Davis Medical Center	Sacramento	California
United States	Scott & White Memorial Hospital	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3 and 6 Months
Primary	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.	6 months