- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02693457
Outcomes Following Suction Drain and Non-suction Drain Assisted Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80210
- Colorado Joint Replacement
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Drain
Intra-articular drain will be placed at closure of randomized knee for 24 hours
|
One randomized knee will be assigned to receive an intra-articular drain procedure following bilateral total knee arthroplasty.
The drain will be removed 24 hours post-operatively.
The patient will be blinded to fluid output from intra-articular drain.
|
EXPERIMENTAL: 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.
|
The contralateral knee will be assigned to a placebo drain procedure following bilateral total knee arthroplasty.
This will blind the patient as to which knee contains the functioning intra-articular drain.
A non-suction/ non-functional subcutaneous drain will act as the placebo drain.
This drain will not output any fluid and will also be removed 24 hours after post-operatively.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lower Extremity Isomechanical Dynomometery
Time Frame: 2 Weeks Post-Operative
|
Knee Extensor Strength
|
2 Weeks Post-Operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lower Extremity Isomechanical Dynomometery
Time Frame: Pre-Operative
|
Knee Extensor strength
|
Pre-Operative
|
Lower Extremity Hand Held Dyanmometry
Time Frame: 48 hours Post-Operative
|
Knee Extensor strength
|
48 hours Post-Operative
|
Lower Extremity Isomechanical Dynomometery
Time Frame: 6 Weeks Post-Operative
|
Knee Extensor strength
|
6 Weeks Post-Operative
|
Lower Extremity Isomechanical Dynomometery
Time Frame: 3 Month Post-Operative
|
Knee Extensor strength
|
3 Month Post-Operative
|
Clinical Quadriceps Activation Battery
Time Frame: Pre-Operative
|
Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)
|
Pre-Operative
|
Clinical Quadriceps Activation Battery
Time Frame: 8 hours Post-Operative
|
Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)
|
8 hours Post-Operative
|
Clinical Quadriceps Activation Battery
Time Frame: 24 hours Post-Operative
|
Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)
|
24 hours Post-Operative
|
Clinical Quadriceps Activation Battery
Time Frame: 48 Hours Post-Operative
|
Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)
|
48 Hours Post-Operative
|
Clinical Quadriceps Activation Battery
Time Frame: 2 weeks Post-Operative
|
Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)
|
2 weeks Post-Operative
|
Clinical Quadriceps Activation Battery
Time Frame: 6 weeks Post-Operative
|
Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)
|
6 weeks Post-Operative
|
Clinical Quadriceps Activation Battery
Time Frame: 3 Months Post-Operative
|
Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)
|
3 Months Post-Operative
|
Bioelectrical Impedance for Swelling
Time Frame: Pre-Operative
|
Using an RJL Systems Quantum Bioelectrical Impedance device, 4 electrodes will be placed on the subject's lower extremity (2 on calculated area of dorsum of foot, 2 on calculated area of anterior surface of thigh).
A 425 microamp current at frequency 50kHz will be delivered to 2 electrodes.
The remaining 2 electrodes will measure the voltage drop (in ohms) based on the resistance from body water content (swelling)
|
Pre-Operative
|
Bioelectrical Impedance for Swelling
Time Frame: 8 hours Post-Operative
|
Using an RJL Systems Quantum Bioelectrical Impedance device, 4 electrodes will be placed on the subject's lower extremity (2 on calculated area of dorsum of foot, 2 on calculated area of anterior surface of thigh).
A 425 microamp current at frequency 50kHz will be delivered to 2 electrodes.
The remaining 2 electrodes will measure the voltage drop (in ohms) based on the resistance from body water content (swelling)
|
8 hours Post-Operative
|
Bioelectrical Impedance for Swelling
Time Frame: 24 hours Post-Operative
|
Using an RJL Systems Quantum Bioelectrical Impedance device, 4 electrodes will be placed on the subject's lower extremity (2 on calculated area of dorsum of foot, 2 on calculated area of anterior surface of thigh).
A 425 microamp current at frequency 50kHz will be delivered to 2 electrodes.
The remaining 2 electrodes will measure the voltage drop (in ohms) based on the resistance from body water content (swelling)
|
24 hours Post-Operative
|
Bioelectrical Impedance for Swelling
Time Frame: 48 Hours Post-Operative
|
Using an RJL Systems Quantum Bioelectrical Impedance device, 4 electrodes will be placed on the subject's lower extremity (2 on calculated area of dorsum of foot, 2 on calculated area of anterior surface of thigh).
A 425 microamp current at frequency 50kHz will be delivered to 2 electrodes.
The remaining 2 electrodes will measure the voltage drop (in ohms) based on the resistance from body water content (swelling)
|
48 Hours Post-Operative
|
Bioelectrical Impedance for Swelling
Time Frame: 2 Weeks Post-Operative
|
Using an RJL Systems Quantum Bioelectrical Impedance device, 4 electrodes will be placed on the subject's lower extremity (2 on calculated area of dorsum of foot, 2 on calculated area of anterior surface of thigh).
A 425 microamp current at frequency 50kHz will be delivered to 2 electrodes.
The remaining 2 electrodes will measure the voltage drop (in ohms) based on the resistance from body water content (swelling)
|
2 Weeks Post-Operative
|
Bioelectrical Impedance for Swelling
Time Frame: 6 Weeks Post-Operative
|
Using an RJL Systems Quantum Bioelectrical Impedance device, 4 electrodes will be placed on the subject's lower extremity (2 on calculated area of dorsum of foot, 2 on calculated area of anterior surface of thigh).
A 425 microamp current at frequency 50kHz will be delivered to 2 electrodes.
The remaining 2 electrodes will measure the voltage drop (in ohms) based on the resistance from body water content (swelling)
|
6 Weeks Post-Operative
|
Bioelectrical Impedance for Swelling
Time Frame: 3 Months Post-Operative
|
Using an RJL Systems Quantum Bioelectrical Impedance device, 4 electrodes will be placed on the subject's lower extremity (2 on calculated area of dorsum of foot, 2 on calculated area of anterior surface of thigh).
A 425 microamp current at frequency 50kHz will be delivered to 2 electrodes.
The remaining 2 electrodes will measure the voltage drop (in ohms) based on the resistance from body water content (swelling)
|
3 Months Post-Operative
|
Circumferential Measure of Swelling
Time Frame: Pre-Operative
|
Using weighted, locking measuring tape, girth measurements will be taken at superior patellar pole and 10 cm proximal from superior patellar pole
|
Pre-Operative
|
Circumferential Measure of Swelling
Time Frame: 8 hours Post-Operative
|
Using weighted, locking measuring tape, girth measurements will be taken at superior patellar pole and 10 cm proximal from superior patellar pole
|
8 hours Post-Operative
|
Circumferential Measure of Swelling
Time Frame: 24 hours Post-Operative
|
Using weighted, locking measuring tape, girth measurements will be taken at superior patellar pole and 10 cm proximal from superior patellar pole
|
24 hours Post-Operative
|
Circumferential Measure of Swelling
Time Frame: 48 Hours Post-Operative
|
Using weighted, locking measuring tape, girth measurements will be taken at superior patellar pole and 10 cm proximal from superior patellar pole
|
48 Hours Post-Operative
|
Circumferential Measure of Swelling
Time Frame: 2 Weeks Post-Operative
|
Using weighted, locking measuring tape, girth measurements will be taken at superior patellar pole and 10 cm proximal from superior patellar pole
|
2 Weeks Post-Operative
|
Circumferential Measure of Swelling
Time Frame: 6 Weeks Post-Operative
|
Using weighted, locking measuring tape, girth measurements will be taken at superior patellar pole and 10 cm proximal from superior patellar pole
|
6 Weeks Post-Operative
|
Circumferential Measure of Swelling
Time Frame: 3 Months Post-Operative
|
Using weighted, locking measuring tape, girth measurements will be taken at superior patellar pole and 10 cm proximal from superior patellar pole
|
3 Months Post-Operative
|
Diagnostic Ultrasound Measure of Effusion
Time Frame: Pre-Operative
|
Trained ultrasonagrapher will quantify the depth of effusion by summing the mm of effusion at three primary recesses (suprapatellar, medial parapatellar, lateral parapatellar).
Diagnotic ultrasound will be performed with subject supine and knee flexed 30 degrees
|
Pre-Operative
|
Diagnostic Ultrasound Measure of Effusion
Time Frame: 48 Hours Post-Operative
|
Trained ultrasonagrapher will quantify the depth of effusion by summing the mm of effusion at three primary recesses (suprapatellar, medial parapatellar, lateral parapatellar).
Diagnotic ultrasound will be performed with subject supine and knee flexed 30 degrees
|
48 Hours Post-Operative
|
Diagnostic Ultrasound Measure of Effusion
Time Frame: 2 Weeks Post-Operative
|
Trained ultrasonagrapher will quantify the depth of effusion by summing the mm of effusion at three primary recesses (suprapatellar, medial parapatellar, lateral parapatellar).
Diagnotic ultrasound will be performed with subject supine and knee flexed 30 degrees
|
2 Weeks Post-Operative
|
Diagnostic Ultrasound Measure of Effusion
Time Frame: 6 Weeks Post-Operative
|
Trained ultrasonagrapher will quantify the depth of effusion by summing the mm of effusion at three primary recesses (suprapatellar, medial parapatellar, lateral parapatellar).
Diagnotic ultrasound will be performed with subject supine and knee flexed 30 degrees
|
6 Weeks Post-Operative
|
Diagnostic Ultrasound Measure of Effusion
Time Frame: 3 Months Post-Operative
|
Trained ultrasonagrapher will quantify the depth of effusion by summing the mm of effusion at three primary recesses (suprapatellar, medial parapatellar, lateral parapatellar).
Diagnotic ultrasound will be performed with subject supine and knee flexed 30 degrees
|
3 Months Post-Operative
|
Knee Pain Measured by Visual Analog Scale
Time Frame: Pre-Operative
|
Pre-Operative
|
|
Knee Pain Measured by Visual Analog Scale
Time Frame: 8 Hours Post-Operative
|
8 Hours Post-Operative
|
|
Knee Pain Measured by Visual Analog Scale
Time Frame: 24 Hours Post-Operative
|
24 Hours Post-Operative
|
|
Knee Pain Measured by Visual Analog Scale
Time Frame: 48 Hours Post-Operative
|
48 Hours Post-Operative
|
|
Knee Pain Measured by Visual Analog Scale
Time Frame: 2 Weeks Post-Operative
|
2 Weeks Post-Operative
|
|
Knee Pain Measured by Visual Analog Scale
Time Frame: 6 Weeks Post-Operative
|
6 Weeks Post-Operative
|
|
Knee Pain Measured by Visual Analog Scale
Time Frame: 3 Months Post-Operative
|
3 Months Post-Operative
|
|
Knee Flexion Range of Motion
Time Frame: Pre-Operative
|
Active and Passive Range of Motion Measured with Goniometer
|
Pre-Operative
|
Knee Flexion Range of Motion
Time Frame: 8 Hours Post-Operative
|
Active and Passive Range of Motion Measured with Goniometer
|
8 Hours Post-Operative
|
Knee Flexion Range of Motion
Time Frame: 24 Hours Post-Operative
|
Active and Passive Range of Motion Measured with Goniometer
|
24 Hours Post-Operative
|
Knee Flexion Range of Motion
Time Frame: 48 Hours Post-Operative
|
Active and Passive Range of Motion Measured with Goniometer
|
48 Hours Post-Operative
|
Knee Flexion Range of Motion
Time Frame: 2 Weeks Post Operative
|
Active and Passive Range of Motion Measured with Goniometer
|
2 Weeks Post Operative
|
Knee Flexion Range of Motion
Time Frame: 6 Weeks Post Operative
|
Active and Passive Range of Motion Measured with Goniometer
|
6 Weeks Post Operative
|
Knee Flexion Range of Motion
Time Frame: 3 Months Post Operative
|
Active and Passive Range of Motion Measured with Goniometer
|
3 Months Post Operative
|
Knee Extension Range of Motion
Time Frame: Pre-Operative
|
Active and Passive Range of Motion Measured with Goniometer
|
Pre-Operative
|
Knee Extension Range of Motion
Time Frame: 8 Hours Post-Operative
|
Active and Passive Range of Motion Measured with Goniometer
|
8 Hours Post-Operative
|
Knee Extension Range of Motion
Time Frame: 24 Hours Post-Operative
|
Active and Passive Range of Motion Measured with Goniometer
|
24 Hours Post-Operative
|
Knee Extension Range of Motion
Time Frame: 48 Hours Post-Operative
|
Active and Passive Range of Motion Measured with Goniometer
|
48 Hours Post-Operative
|
Knee Extension Range of Motion
Time Frame: 2 Weeks Post-Operative
|
Active and Passive Range of Motion Measured with Goniometer
|
2 Weeks Post-Operative
|
Knee Extension Range of Motion
Time Frame: 6 Weeks Post-Operative
|
Active and Passive Range of Motion Measured with Goniometer
|
6 Weeks Post-Operative
|
Knee Extension Range of Motion
Time Frame: 3 Months Post-Operative
|
Active and Passive Range of Motion Measured with Goniometer
|
3 Months Post-Operative
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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, Avon). 2014 Sep;29(8):923-9. doi: 10.1016/j.clinbiomech.2014.06.014. Epub 2014 Jul 4.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1541
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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