Outcomes Following Suction Drain and Non-suction Drain Assisted Total Knee Arthroplasty



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:Any - 70
Updated:7/19/2018
Start Date:February 2016
End Date:December 29, 2017

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This randomized controlled trial is designed to determine the effect of suction drain usage
on the reduction of postoperative swelling following total knee replacement. Furthermore,
this study will determine the relationship between postoperative swelling and quadriceps
muscle function. This study will be performed in a cohort of patients undergoing bilateral
total knee replacement and the suction intra-articular drain will be randomized to one of the
two operative knees prior to surgery.

This study has two primary aims: 1) to determine the effects of intra-articular suction drain
use, placed during total knee arthroplasty (TKA), on postoperative knee joint effusion, which
is the collection of fluid in the joint capsule, and lower extremity swelling compared to a
TKA without the use of an intra-articular drain and, 2) to describe the relationship between
postoperative lower extremity swelling and quadriceps function (strength and activation). The
use of intra-articular drains during TKA surgery has been highly disputed, due to the fear of
increasing risk of infection from a secondary incision site, however, past studies have found
no increased risk of complication from drain use. Furthermore, studies have shown that drain
use may reduce the amount of hidden blood loss, or blood that is collected in the
intra-articular space. Of interest, effusion may be associated with decreased quadriceps
function. Previous research examining the influence of knee effusion on quadriceps function
has shown that with laboratory-induced acute knee effusion, quadriceps activation and force
production are reduced. However, previous findings lack the ability to inform care for
patients following TKA due to the acute nature of the effusion and the inability to translate
findings from healthy individuals to a clinical population. This study has the potential to
greatly improve care for patients undergoing TKA by informing the surgical procedure while
also providing important evidence for the influence of postoperative swelling on quadriceps
muscle function.

In order to maintain patient blinding, a non-functional subcutaneous drain will be placed in
the non-randomized knee. Patients will be blinded to any fluid output from the
intra-articular drain.

A medial parapatellar approach will be utilized for exposure of the knee. All TKAs will be
performed using a gap balancing technique with substitution of the posterior collateral
ligament (PCL). In all cases, a tensioning device will be used to establish balanced,
symmetrical flexion and extension spaces. All TKA procedures will utilize cemented implants.
Randomly assigned drains (intra-articular or subcutaneous) will be placed in respective knees
before closure. All patients will be treated with Tranexamic Acid intravenously to
standardize blood loss and effusion.

All patients will be provided standard rehabilitation protocol during their inpatient stay.
After hospital discharge, patients will be encouraged to receive outpatient physical therapy
2-3 times per week for 6 weeks.

Inclusion Criteria:

- Age ≤ 70 years

- Undergoing bilateral, simultaneous, primary knee replacements

Exclusion Criteria:

- neurological, vascular or cardiac problems that limit function

- unstable orthopedic conditions that limit functional performance

- previous history of inflammatory arthritis or other inflammatory systemic conditions

- previous history of deep vein thrombosis in either lower extremity

- lymphedema or other conditions that lead to lower extremity edema that may influence
the outcomes of the study.
We found this trial at
1
site
Denver, Colorado 80210
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Denver, CO
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