A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains
Spine Deformity
Bottom Line
View on ClinicalTrials.gov: NCT02286102 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OrthoPAT (Device); Constavac (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Volume of Allogenic Blood Transfused Postoperatively |
458.33; 382.35 | — |
| SECONDARY Hemoglobin Levels, Post-Op Day 3 |
9.07; 9.9 | — |
| SECONDARY Hemoglobin Levels, Post-Op Day 2 |
9.33; 10.19 | — |
Summary
Eligibility Criteria
Inclusion Criteria
The patient is at least 18 years of age The patient is to undergo posterior spine surgery in the thoracic or lumbar region for deformity correction of greater than 6 levels The patient has signed a patient Informed Consent
Exclusion Criteria
The patient is less than 18 years of age The patient has a hematologic disorder of any etiology The patient has received active anticoagulant therapy, including aspirin, Plavix, Heparin, Lovenox or Coumadin within one week of admission The patient has a known active infection or malignancy. The patient has a terminal illness with a life expectancy of less than one year.
The patient requires immuno-suppressive therapy. The patient is undergoing a combined anterior/posterior fusion. The patient has a history of drug or alcohol abuse that may interfere with his/her ability to provide written informed consent.
Data sourced from ClinicalTrials.gov (NCT02286102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.