Perfusion Assessment of Wound Closure Techniques in Primary Total Knee Arthroplasty
Assessment of Wound Closure Techniques in Primary Total Knee Arthroplasty Using SPY Intra-operative Angiography
1 other identifier
interventional
45
1 country
1
Brief Summary
This study will assess which of the three most common methods of wound closure in primary total knee arthroplasty (staples, interrupted vertical mattress, or running subcuticular suture) provide the best wound vascular perfusion. This can be achieve by using SPY intra-operative vascular angiography, which is commonly used in clinical practice to assess perfusion of wound closure at the clinic. By understanding the differences in perfusion afforded by different closure techniques, surgeons will then be able to select the technique that optimizes this parameter so as to avoid complications such as tissue necrosis, wound dehiscence, or infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 14, 2013
CompletedFirst Posted
Study publicly available on registry
August 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFebruary 16, 2015
February 1, 2015
11 months
August 14, 2013
February 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Perfusion of Wound Closure
Surgical Point of Care
Study Arms (3)
Staple Closure
EXPERIMENTALStaple closure will be one technique employed to close the wound in primary total knee arthroplasty.
Running Subcuticular Closure
EXPERIMENTALRunning subcuticular closure will be one technique employed to close the wound in primary total knee arthroplasty.
Vertical Mattress Closure
EXPERIMENTALVertical mattress closure will be one technique employed to close the wound in primary total knee arthroplasty.
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 18 years old
- Primary diagnosis of osteoarthritis
- Surgical indication for index total knee arthroplasty
You may not qualify if:
- Previous surgery about the knee
- Systemic corticosteroid use
- Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Publications (1)
Wyles CC, Jacobson SR, Houdek MT, Larson DR, Taunton MJ, Sim FH, Sierra RJ, Trousdale RT. The Chitranjan Ranawat Award: Running Subcuticular Closure Enables the Most Robust Perfusion After TKA: A Randomized Clinical Trial. Clin Orthop Relat Res. 2016 Jan;474(1):47-56. doi: 10.1007/s11999-015-4209-x.
PMID: 25733009DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Trousdale, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Orthopedic Surgery
Study Record Dates
First Submitted
August 14, 2013
First Posted
August 16, 2013
Study Start
August 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
February 16, 2015
Record last verified: 2015-02