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NCT Number: NCT02693457

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Bilateral Total Knee Arthroplasty Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

Up to 70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado Joint Replacement

Denver, Colorado, 80210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Drain

Procedure

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

Procedure

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.

Primary outcomes

  1. Lower Extremity Isomechanical Dynomometery

    Time frame: 2 Weeks Post-Operative

    Knee Extensor Strength

Secondary outcomes

  1. Lower Extremity Isomechanical Dynomometery

    Time frame: Pre-Operative

    Knee Extensor strength

  2. Lower Extremity Hand Held Dyanmometry

    Time frame: 48 hours Post-Operative

    Knee Extensor strength

  3. Lower Extremity Isomechanical Dynomometery

    Time frame: 6 Weeks Post-Operative

    Knee Extensor strength

  4. Lower Extremity Isomechanical Dynomometery

    Time frame: 3 Month Post-Operative

    Knee Extensor strength

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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)

  18. 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)

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. Knee Pain Measured by Visual Analog Scale

    Time frame: Pre-Operative

  32. Knee Pain Measured by Visual Analog Scale

    Time frame: 8 Hours Post-Operative

  33. Knee Pain Measured by Visual Analog Scale

    Time frame: 24 Hours Post-Operative

  34. Knee Pain Measured by Visual Analog Scale

    Time frame: 48 Hours Post-Operative

  35. Knee Pain Measured by Visual Analog Scale

    Time frame: 2 Weeks Post-Operative

  36. Knee Pain Measured by Visual Analog Scale

    Time frame: 6 Weeks Post-Operative

  37. Knee Pain Measured by Visual Analog Scale

    Time frame: 3 Months Post-Operative

  38. Knee Flexion Range of Motion

    Time frame: Pre-Operative

    Active and Passive Range of Motion Measured with Goniometer

  39. Knee Flexion Range of Motion

    Time frame: 8 Hours Post-Operative

    Active and Passive Range of Motion Measured with Goniometer

  40. Knee Flexion Range of Motion

    Time frame: 24 Hours Post-Operative

    Active and Passive Range of Motion Measured with Goniometer

  41. Knee Flexion Range of Motion

    Time frame: 48 Hours Post-Operative

    Active and Passive Range of Motion Measured with Goniometer

  42. Knee Flexion Range of Motion

    Time frame: 2 Weeks Post Operative

    Active and Passive Range of Motion Measured with Goniometer

  43. Knee Flexion Range of Motion

    Time frame: 6 Weeks Post Operative

    Active and Passive Range of Motion Measured with Goniometer

  44. Knee Flexion Range of Motion

    Time frame: 3 Months Post Operative

    Active and Passive Range of Motion Measured with Goniometer

  45. Knee Extension Range of Motion

    Time frame: Pre-Operative

    Active and Passive Range of Motion Measured with Goniometer

  46. Knee Extension Range of Motion

    Time frame: 8 Hours Post-Operative

    Active and Passive Range of Motion Measured with Goniometer

  47. Knee Extension Range of Motion

    Time frame: 24 Hours Post-Operative

    Active and Passive Range of Motion Measured with Goniometer

  48. Knee Extension Range of Motion

    Time frame: 48 Hours Post-Operative

    Active and Passive Range of Motion Measured with Goniometer

  49. Knee Extension Range of Motion

    Time frame: 2 Weeks Post-Operative

    Active and Passive Range of Motion Measured with Goniometer

  50. Knee Extension Range of Motion

    Time frame: 6 Weeks Post-Operative

    Active and Passive Range of Motion Measured with Goniometer

  51. Knee Extension Range of Motion

    Time frame: 3 Months Post-Operative

    Active and Passive Range of Motion Measured with Goniometer

Sponsors and collaborators

Lead sponsor

Colorado Joint Replacement

Other

Collaborators

  • CommonSpirit Health
  • University of Colorado, Denver

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 26, 2016
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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