Outcomes Following Suction Drain and Non-suction Drain Assisted Total Knee Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Colorado Joint Replacement
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Lower Extremity Isomechanical Dynomometery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- — to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Drain
Intra-articular drain will be placed at closure of randomized knee for 24 hours
Intervention: Drain (Procedure)
No Drain
No intra-articular will be placed in the contralateral knee of the same patient. A placebo drain will be placed so patient is unaware of which knee contains working drain.
Intervention: No Drain (Procedure)
Outcomes
Primary Outcomes
Lower Extremity Isomechanical Dynomometery
Time Frame: 2 Weeks Post-Operative
Knee Extensor Strength
Secondary Outcomes
- Lower Extremity Isomechanical Dynomometery(3 Month Post-Operative)
- Clinical Quadriceps Activation Battery(3 Months Post-Operative)
- Knee Pain Measured by Visual Analog Scale(3 Months Post-Operative)
- Knee Extension Range of Motion(3 Months Post-Operative)
- Bioelectrical Impedance for Swelling(3 Months Post-Operative)
- Knee Flexion Range of Motion(3 Months Post Operative)
- Lower Extremity Hand Held Dyanmometry(48 hours Post-Operative)
- Circumferential Measure of Swelling(3 Months Post-Operative)
- Diagnostic Ultrasound Measure of Effusion(3 Months Post-Operative)
- Knee Pain Measured by Visual Analog Scale(6 Weeks Post-Operative)
- Lower Extremity Isomechanical Dynomometery(Pre-Operative)
- Lower Extremity Isomechanical Dynomometery(6 Weeks Post-Operative)
- Clinical Quadriceps Activation Battery(Pre-Operative)
- Clinical Quadriceps Activation Battery(8 hours Post-Operative)
- Clinical Quadriceps Activation Battery(24 hours Post-Operative)
- Knee Pain Measured by Visual Analog Scale(Pre-Operative)
- Clinical Quadriceps Activation Battery(48 Hours Post-Operative)
- Clinical Quadriceps Activation Battery(2 weeks Post-Operative)
- Clinical Quadriceps Activation Battery(6 weeks Post-Operative)
- Bioelectrical Impedance for Swelling(Pre-Operative)
- Bioelectrical Impedance for Swelling(8 hours Post-Operative)
- Bioelectrical Impedance for Swelling(24 hours Post-Operative)
- Circumferential Measure of Swelling(8 hours Post-Operative)
- Bioelectrical Impedance for Swelling(48 Hours Post-Operative)
- Bioelectrical Impedance for Swelling(2 Weeks Post-Operative)
- Bioelectrical Impedance for Swelling(6 Weeks Post-Operative)
- Knee Pain Measured by Visual Analog Scale(8 Hours Post-Operative)
- Circumferential Measure of Swelling(Pre-Operative)
- Circumferential Measure of Swelling(24 hours Post-Operative)
- Circumferential Measure of Swelling(48 Hours Post-Operative)
- Circumferential Measure of Swelling(2 Weeks Post-Operative)
- Circumferential Measure of Swelling(6 Weeks Post-Operative)
- Diagnostic Ultrasound Measure of Effusion(Pre-Operative)
- Diagnostic Ultrasound Measure of Effusion(48 Hours Post-Operative)
- Diagnostic Ultrasound Measure of Effusion(2 Weeks Post-Operative)
- Diagnostic Ultrasound Measure of Effusion(6 Weeks Post-Operative)
- Knee Pain Measured by Visual Analog Scale(24 Hours Post-Operative)
- Knee Pain Measured by Visual Analog Scale(48 Hours Post-Operative)
- Knee Pain Measured by Visual Analog Scale(2 Weeks Post-Operative)
- Knee Flexion Range of Motion(Pre-Operative)
- Knee Flexion Range of Motion(8 Hours Post-Operative)
- Knee Flexion Range of Motion(24 Hours Post-Operative)
- Knee Flexion Range of Motion(48 Hours Post-Operative)
- Knee Flexion Range of Motion(2 Weeks Post Operative)
- Knee Flexion Range of Motion(6 Weeks Post Operative)
- Knee Extension Range of Motion(Pre-Operative)
- Knee Extension Range of Motion(8 Hours Post-Operative)
- Knee Extension Range of Motion(24 Hours Post-Operative)
- Knee Extension Range of Motion(48 Hours Post-Operative)
- Knee Extension Range of Motion(2 Weeks Post-Operative)
- Knee Extension Range of Motion(6 Weeks Post-Operative)
Investigators
Jason Jennings, MD
Principal Investigator, Orthopedic Surgeon
Colorado Joint Replacement