Status:
COMPLETED
Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty
Lead Sponsor:
Hvidovre University Hospital
Conditions:
Total Knee Arthroplasty
Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study's primary objective is to compare the following parameters between wound closure following primary TKA with and without supplement tissue adhesive (Leukosan®):
Detailed Description
Prolonged wound drainage following total joint replacement surgery has been shown to be a predictor of Periprosthetic Joint Infection (PJI) 1-3. Several studies have highlighted this subject, and esti...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Patient \> 18 years of age.
- Patients determined to be suitable for primary simultaneous bilateral TKA based on physical exam and medical history including the following:
- o Osteoarthritis (OA)
- Patient is skeletally mature.
- Patient is willing and able to provide written informed consent.
- Participants must be able to speak and understand Danish
- Patient is willing and able to cooperate in the required post-operative therapy.
- Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
- Exclusion criteria
- Patients with previous open knee surgery on either knee (i.e., osteotomy, unicompartemental arthroplasty, osteosynthesis)
- Patients with previous major trauma to either knee resulting in deformity og scarring.
- Patients receiving treatment for DVT or PE postoperatively.
- Patients with known allergy to skin adhesives
Exclusion
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03289247
Start Date
September 1 2015
End Date
December 31 2018
Last Update
January 25 2019
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