Clinical Trial: Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Randomized-Controlled, Multicenter Study Evaluating Primary Plating in High-Risk Median Sternotomy Patients for Osteosynthesis and Pain
Brief 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.
Detailed Summary: 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.
Sponsor: Zimmer Biomet
Current Primary Outcome:
- CT Scan Evaluation of Sternal Bone Healing [ Time Frame: 3 and 6 Months ]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)
- Activity Based Total Visual Analog Pain Score [ Time Frame: 6 months ]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.
Original Primary Outcome: Reduction in anterior chest wall pain [ Time Frame: 3-6 weeks ]
Current Secondary Outcome:
Original Secondary Outcome: Return to normal physical activity [ Time Frame: 6 months ]
Information By: Zimmer Biomet
Dates:
Date Received: January 6, 2009
Date Started: November 2008
Date Completion:
Last Updated: May 1, 2013
Last Verified: May 2013
