Clinical trial NCT02693457: Outcomes Following Suction Drain and Non-suction Drain Assisted Total Knee Arthroplasty
Official title: Outcomes Following Suction Drain and Non-suction Drain Assisted Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Bilateral Total Knee Arthroplasty
Lead sponsor: Colorado Joint Replacement
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: CommonSpirit Health
First posted: 2016-02-26
Enrollment: 29
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lower Extremity Isomechanical Dynomometery
timeFrame: 2 Weeks Post-Operative
Secondary outcomes:
measure: Lower Extremity Isomechanical Dynomometery
timeFrame: Pre-Operative
measure: Lower Extremity Hand Held Dyanmometry
timeFrame: 48 hours Post-Operative
measure: Lower Extremity Isomechanical Dynomometery
timeFrame: 6 Weeks Post-Operative
measure: Lower Extremity Isomechanical Dynomometery
timeFrame: 3 Month Post-Operative
measure: Clinical Quadriceps Activation Battery
timeFrame: Pre-Operative
measure: Clinical Quadriceps Activation Battery
timeFrame: 8 hours Post-Operative
measure: Clinical Quadriceps Activation Battery
timeFrame: 24 hours Post-Operative
measure: Clinical Quadriceps Activation Battery
timeFrame: 48 Hours Post-Operative
measure: Clinical Quadriceps Activation Battery
timeFrame: 2 weeks Post-Operative
measure: Clinical Quadriceps Activation Battery
timeFrame: 6 weeks Post-Operative
measure: Clinical Quadriceps Activation Battery
timeFrame: 3 Months Post-Operative
measure: Bioelectrical Impedance for Swelling
timeFrame: Pre-Operative
measure: Bioelectrical Impedance for Swelling
timeFrame: 8 hours Post-Operative
measure: Bioelectrical Impedance for Swelling
timeFrame: 24 hours Post-Operative
measure: Bioelectrical Impedance for Swelling
timeFrame: 48 Hours Post-Operative
measure: Bioelectrical Impedance for Swelling
timeFrame: 2 Weeks Post-Operative
measure: Bioelectrical Impedance for Swelling
timeFrame: 6 Weeks Post-Operative
measure: Bioelectrical Impedance for Swelling
timeFrame: 3 Months Post-Operative
measure: Circumferential Measure of Swelling
timeFrame: Pre-Operative
measure: Circumferential Measure of Swelling
timeFrame: 8 hours Post-Operative
measure: Circumferential Measure of Swelling
timeFrame: 24 hours Post-Operative
measure: Circumferential Measure of Swelling
timeFrame: 48 Hours Post-Operative
measure: Circumferential Measure of Swelling
timeFrame: 2 Weeks Post-Operative
measure: Circumferential Measure of Swelling
timeFrame: 6 Weeks Post-Operative
measure: Circumferential Measure of Swelling
timeFrame: 3 Months Post-Operative
measure: Diagnostic Ultrasound Measure of Effusion
timeFrame: Pre-Operative
measure: Diagnostic Ultrasound Measure of Effusion
timeFrame: 48 Hours Post-Operative
measure: Diagnostic Ultrasound Measure of Effusion
timeFrame: 2 Weeks Post-Operative
measure: Diagnostic Ultrasound Measure of Effusion
timeFrame: 6 Weeks Post-Operative
measure: Diagnostic Ultrasound Measure of Effusion
timeFrame: 3 Months Post-Operative
measure: Knee Pain Measured by Visual Analog Scale
timeFrame: Pre-Operative
measure: Knee Pain Measured by Visual Analog Scale
timeFrame: 8 Hours Post-Operative
measure: Knee Pain Measured by Visual Analog Scale
timeFrame: 24 Hours Post-Operative
measure: Knee Pain Measured by Visual Analog Scale
timeFrame: 48 Hours Post-Operative
measure: Knee Pain Measured by Visual Analog Scale
timeFrame: 2 Weeks Post-Operative
measure: Knee Pain Measured by Visual Analog Scale
timeFrame: 6 Weeks Post-Operative
measure: Knee Pain Measured by Visual Analog Scale
timeFrame: 3 Months Post-Operative
measure: Knee Flexion Range of Motion
timeFrame: Pre-Operative
measure: Knee Flexion Range of Motion
timeFrame: 8 Hours Post-Operative
measure: Knee Flexion Range of Motion
timeFrame: 24 Hours Post-Operative
measure: Knee Flexion Range of Motion
timeFrame: 48 Hours Post-Operative
measure: Knee Flexion Range of Motion
timeFrame: 2 Weeks Post Operative
measure: Knee Flexion Range of Motion
timeFrame: 6 Weeks Post Operative
measure: Knee Flexion Range of Motion
timeFrame: 3 Months Post Operative
measure: Knee Extension Range of Motion
timeFrame: Pre-Operative
measure: Knee Extension Range of Motion
timeFrame: 8 Hours Post-Operative
measure: Knee Extension Range of Motion
timeFrame: 24 Hours Post-Operative
measure: Knee Extension Range of Motion
timeFrame: 48 Hours Post-Operative
measure: Knee Extension Range of Motion
timeFrame: 2 Weeks Post-Operative
measure: Knee Extension Range of Motion
timeFrame: 6 Weeks Post-Operative
measure: Knee Extension Range of Motion
timeFrame: 3 Months Post-Operative
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
Study officials:
affiliation: Colorado Joint Replacement
name: Jason Jennings, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Esler CN, Blakeway C, Fiddian NJ. The use of a closed-suction drain in total knee arthroplasty. A prospective, randomised study. J Bone Joint Surg Br. 2003 Mar;85(2):215-7. doi: 10.1302/0301-620x.85b2.13357.
citation: Holt BT, Parks NL, Engh GA, Lawrence JM. Comparison of closed-suction drainage and no drainage after primary total knee arthroplasty. Orthopedics. 1997 Dec;20(12):1121-4; discussion 1124-5. doi: 10.3928/0147-7447-19971201-05.
citation: Palmieri-Smith RM, Villwock M, Downie B, Hecht G, Zernicke R. Pain and effusion and quadriceps activation and strength. J Athl Train. 2013 Mar-Apr;48(2):186-91. doi: 10.4085/1062-6050-48.2.10. Epub 2013 Feb 20.
citation: Pietrosimone B, Lepley AS, Murray AM, Thomas AC, Bahhur NO, Schwartz TA. Changes in voluntary quadriceps activation predict changes in muscle strength and gait biomechanics following knee joint effusion. Clin Biomech (Bristol). 2014 Sep;29(8):923-9. doi: 10.1016/j.clinbiomech.2014.06.014. Epub 2014 Jul 4.