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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693457
• Other study ID #: 1541
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 29, 2017

Study information

• Verified date: July 2018
• Source: Colorado Joint Replacement
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 29, 2017
• Est. primary completion date: December 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bilateral Total Knee Arthroplasty
• Osteoarthritis

Intervention

Procedure:
• Drain
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.
• No 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.

Locations

Country	Name	City	State
United States	Colorado Joint Replacement	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
Colorado Joint Replacement	Centura Health, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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, Avon). 2014 Sep;29(8):923-9. doi: 10.1016/j.clinbiomech.2014.06.014. Epub 2014 Jul 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower Extremity Isomechanical Dynomometery	Knee Extensor Strength	2 Weeks Post-Operative
Secondary	Lower Extremity Isomechanical Dynomometery	Knee Extensor strength	Pre-Operative
Secondary	Lower Extremity Hand Held Dyanmometry	Knee Extensor strength	48 hours Post-Operative
Secondary	Lower Extremity Isomechanical Dynomometery	Knee Extensor strength	6 Weeks Post-Operative
Secondary	Lower Extremity Isomechanical Dynomometery	Knee Extensor strength	3 Month Post-Operative
Secondary	Clinical Quadriceps Activation Battery	Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)	Pre-Operative
Secondary	Clinical Quadriceps Activation Battery	Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)	8 hours Post-Operative
Secondary	Clinical Quadriceps Activation Battery	Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)	24 hours Post-Operative
Secondary	Clinical Quadriceps Activation Battery	Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)	48 Hours Post-Operative
Secondary	Clinical Quadriceps Activation Battery	Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)	2 weeks Post-Operative
Secondary	Clinical Quadriceps Activation Battery	Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)	6 weeks Post-Operative
Secondary	Clinical Quadriceps Activation Battery	Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)	3 Months Post-Operative
Secondary	Bioelectrical Impedance for Swelling	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
Secondary	Bioelectrical Impedance for Swelling	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
Secondary	Bioelectrical Impedance for Swelling	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
Secondary	Bioelectrical Impedance for Swelling	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
Secondary	Bioelectrical Impedance for Swelling	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
Secondary	Bioelectrical Impedance for Swelling	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
Secondary	Bioelectrical Impedance for Swelling	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
Secondary	Circumferential Measure of Swelling	Using weighted, locking measuring tape, girth measurements will be taken at superior patellar pole and 10 cm proximal from superior patellar pole	Pre-Operative
Secondary	Circumferential Measure of Swelling	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
Secondary	Circumferential Measure of Swelling	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
Secondary	Circumferential Measure of Swelling	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
Secondary	Circumferential Measure of Swelling	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
Secondary	Circumferential Measure of Swelling	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
Secondary	Circumferential Measure of Swelling	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
Secondary	Diagnostic Ultrasound Measure of Effusion	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
Secondary	Diagnostic Ultrasound Measure of Effusion	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
Secondary	Diagnostic Ultrasound Measure of Effusion	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
Secondary	Diagnostic Ultrasound Measure of Effusion	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
Secondary	Diagnostic Ultrasound Measure of Effusion	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
Secondary	Knee Pain Measured by Visual Analog Scale		Pre-Operative
Secondary	Knee Pain Measured by Visual Analog Scale		8 Hours Post-Operative
Secondary	Knee Pain Measured by Visual Analog Scale		24 Hours Post-Operative
Secondary	Knee Pain Measured by Visual Analog Scale		48 Hours Post-Operative
Secondary	Knee Pain Measured by Visual Analog Scale		2 Weeks Post-Operative
Secondary	Knee Pain Measured by Visual Analog Scale		6 Weeks Post-Operative
Secondary	Knee Pain Measured by Visual Analog Scale		3 Months Post-Operative
Secondary	Knee Flexion Range of Motion	Active and Passive Range of Motion Measured with Goniometer	Pre-Operative
Secondary	Knee Flexion Range of Motion	Active and Passive Range of Motion Measured with Goniometer	8 Hours Post-Operative
Secondary	Knee Flexion Range of Motion	Active and Passive Range of Motion Measured with Goniometer	24 Hours Post-Operative
Secondary	Knee Flexion Range of Motion	Active and Passive Range of Motion Measured with Goniometer	48 Hours Post-Operative
Secondary	Knee Flexion Range of Motion	Active and Passive Range of Motion Measured with Goniometer	2 Weeks Post Operative
Secondary	Knee Flexion Range of Motion	Active and Passive Range of Motion Measured with Goniometer	6 Weeks Post Operative
Secondary	Knee Flexion Range of Motion	Active and Passive Range of Motion Measured with Goniometer	3 Months Post Operative
Secondary	Knee Extension Range of Motion	Active and Passive Range of Motion Measured with Goniometer	Pre-Operative
Secondary	Knee Extension Range of Motion	Active and Passive Range of Motion Measured with Goniometer	8 Hours Post-Operative
Secondary	Knee Extension Range of Motion	Active and Passive Range of Motion Measured with Goniometer	24 Hours Post-Operative
Secondary	Knee Extension Range of Motion	Active and Passive Range of Motion Measured with Goniometer	48 Hours Post-Operative
Secondary	Knee Extension Range of Motion	Active and Passive Range of Motion Measured with Goniometer	2 Weeks Post-Operative
Secondary	Knee Extension Range of Motion	Active and Passive Range of Motion Measured with Goniometer	6 Weeks Post-Operative
Secondary	Knee Extension Range of Motion	Active and Passive Range of Motion Measured with Goniometer	3 Months Post-Operative