Perfusion Assessment of Wound Closure Techniques in Primary Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

Assessment of Wound Closure Techniques in Primary Total Knee Arthroplasty Using SPY Intra-operative Angiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924403
• Other study ID #: 13-005083
• Status: Completed
• Phase: N/A
• First received: August 14, 2013
• Last updated: February 13, 2015
• Start date: August 2013
• Est. completion date: July 2014

Study information

• Verified date: February 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years old

• Primary diagnosis of osteoarthritis

• Surgical indication for index total knee arthroplasty

Exclusion Criteria:

• Previous surgery about the knee

• Systemic corticosteroid use

• Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Procedure:
• Staple Closure

• Vertical Mattress Closure

• Running Subcuticular Closure

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfusion of Wound Closure		Surgical Point of Care	Yes