Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain (RESTORE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00819286
First received: January 6, 2009
Last updated: May 1, 2013
Last verified: May 2013

January 6, 2009
May 1, 2013
November 2008
January 2011   (final data collection date for primary outcome measure)
  • CT Scan Evaluation of Sternal Bone Healing [ Time Frame: 3 and 6 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Reduction in anterior chest wall pain [ Time Frame: 3-6 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00819286 on ClinicalTrials.gov Archive Site
Not Provided
Return to normal physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
A Prospective, Randomized-Controlled, Multicenter Study Evaluating Primary Plating in High-Risk Median Sternotomy Patients for Osteosynthesis and Pain

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sternal Wound Infection
  • Sternal Non-union
  • Pain
  • Mediastinitis
  • Device: SternaLock Rigid Fixation System
    patients will have their sternum closed by rigid fixation using SternaLock plates.
  • Device: Wire (control)
    patients will have their sternum closed using stainless steel wires.
  • Active Comparator: wire (control)
    patients will have their sternum closed using stainless steel wires.
    Intervention: Device: Wire (control)
  • Experimental: plates
    patients will have their sternum closed by rigid fixation using SternaLock plates.
    Intervention: Device: SternaLock Rigid Fixation System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
December 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00819286
07071
No
Biomet, Inc.
Biomet, Inc.
Not Provided
Study Chair: Jai Raman, MD University of Chicago
Principal Investigator: Michael Wong, MD University of California Davis Medical Center, Sacramento, CA
Principal Investigator: Brian DeGuzmann, MD St. Joseph's Medical Center, Phoenix, AZ
Principal Investigator: Sven Lehmann, MD Leipzig Heart Center, Leipzig, Germany
Principal Investigator: Kenton Zehr, MD Scott & White Memorial Hospital, Temple, TX
Principal Investigator: H Edward Garrett, Jr, MD Baptist Memorial Hospital, Memphis, TN
Biomet, Inc.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP