OsteoarthritisNCT02693457
Outcomes Following Suction Drain and Non-suction Drain Assisted Total Knee Arthroplasty
A study testing Drain and No Drain in people with Osteoarthritis and Bilateral Total Knee Arthroplasty, run by Colorado Joint Replacement at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Osteoarthritis, Bilateral Total Knee Arthroplasty
- What is being tested?
- Drain and No Drain
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 29 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≤ 70 years
- Undergoing bilateral, simultaneous, primary knee replacements
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis, Bilateral Total Knee Arthroplasty
- Being tested
- Drain, No Drain
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrainProcedure or surgery
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 DrainProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Drain | Active comparator | Intra-articular drain will be placed at closure of randomized knee for 24 hours Receives: Procedure: Drain |
| No Drain | Experimental | 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. Receives: Procedure: No Drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Isomechanical Dynomometery
Knee Extensor Strength
Measured: 2 Weeks Post-Operative
Secondary outcomes (51)
Lower Extremity Isomechanical Dynomometery
Knee Extensor strength
Measured: Pre-Operative
Lower Extremity Hand Held Dyanmometry
Knee Extensor strength
Measured: 48 hours Post-Operative
Lower Extremity Isomechanical Dynomometery
Knee Extensor strength
Measured: 6 Weeks Post-Operative
Lower Extremity Isomechanical Dynomometery
Knee Extensor strength
Measured: 3 Month Post-Operative
Clinical Quadriceps Activation Battery
Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)
Measured: Pre-Operative
Clinical Quadriceps Activation Battery
Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)
Measured: 8 hours Post-Operative
Clinical Quadriceps Activation Battery
Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)
Measured: 24 hours Post-Operative
Clinical Quadriceps Activation Battery
Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)
Measured: 48 Hours Post-Operative
Clinical Quadriceps Activation Battery
Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)
Measured: 2 weeks Post-Operative
Clinical Quadriceps Activation Battery
Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)
Measured: 6 weeks Post-Operative
Clinical Quadriceps Activation Battery
Isometric Quadriceps Set, Knee Extension Lag Test, Straight Leg Raise- Scale 0-6 (2 points for each test)
Measured: 3 Months Post-Operative
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)
Measured: Pre-Operative
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)
Measured: 8 hours Post-Operative
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)
Measured: 24 hours Post-Operative
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)
Measured: 48 Hours Post-Operative
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)
Measured: 2 Weeks Post-Operative
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)
Measured: 6 Weeks Post-Operative
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)
Measured: 3 Months Post-Operative
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
Measured: Pre-Operative
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
Measured: 8 hours Post-Operative
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
Measured: 24 hours Post-Operative
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
Measured: 48 Hours Post-Operative
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
Measured: 2 Weeks Post-Operative
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
Measured: 6 Weeks Post-Operative
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
Measured: 3 Months Post-Operative
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
Measured: Pre-Operative
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
Measured: 48 Hours Post-Operative
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
Measured: 2 Weeks Post-Operative
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
Measured: 6 Weeks Post-Operative
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
Measured: 3 Months Post-Operative
Knee Pain Measured by Visual Analog Scale
Measured: Pre-Operative
Knee Pain Measured by Visual Analog Scale
Measured: 8 Hours Post-Operative
Knee Pain Measured by Visual Analog Scale
Measured: 24 Hours Post-Operative
Knee Pain Measured by Visual Analog Scale
Measured: 48 Hours Post-Operative
Knee Pain Measured by Visual Analog Scale
Measured: 2 Weeks Post-Operative
Knee Pain Measured by Visual Analog Scale
Measured: 6 Weeks Post-Operative
Knee Pain Measured by Visual Analog Scale
Measured: 3 Months Post-Operative
Knee Flexion Range of Motion
Active and Passive Range of Motion Measured with Goniometer
Measured: Pre-Operative
Knee Flexion Range of Motion
Active and Passive Range of Motion Measured with Goniometer
Measured: 8 Hours Post-Operative
Knee Flexion Range of Motion
Active and Passive Range of Motion Measured with Goniometer
Measured: 24 Hours Post-Operative
Knee Flexion Range of Motion
Active and Passive Range of Motion Measured with Goniometer
Measured: 48 Hours Post-Operative
Knee Flexion Range of Motion
Active and Passive Range of Motion Measured with Goniometer
Measured: 2 Weeks Post Operative
Knee Flexion Range of Motion
Active and Passive Range of Motion Measured with Goniometer
Measured: 6 Weeks Post Operative
Knee Flexion Range of Motion
Active and Passive Range of Motion Measured with Goniometer
Measured: 3 Months Post Operative
Knee Extension Range of Motion
Active and Passive Range of Motion Measured with Goniometer
Measured: Pre-Operative
Knee Extension Range of Motion
Active and Passive Range of Motion Measured with Goniometer
Measured: 8 Hours Post-Operative
Knee Extension Range of Motion
Active and Passive Range of Motion Measured with Goniometer
Measured: 24 Hours Post-Operative
Knee Extension Range of Motion
Active and Passive Range of Motion Measured with Goniometer
Measured: 48 Hours Post-Operative
Knee Extension Range of Motion
Active and Passive Range of Motion Measured with Goniometer
Measured: 2 Weeks Post-Operative
Knee Extension Range of Motion
Active and Passive Range of Motion Measured with Goniometer
Measured: 6 Weeks Post-Operative
Knee Extension Range of Motion
Active and Passive Range of Motion Measured with Goniometer
Measured: 3 Months Post-Operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion29 Dec 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado Joint Replacement
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, CommonSpirit Health
- Responsible party
- Principal investigator, Jason Jennings, MD, Colorado Joint Replacement
- Investigators
- Jason Jennings, MD, Principal investigator, Colorado Joint Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693457
- Sponsor's protocol ID
- 1541
- Status last verified
- Jul 2018
- First submitted
- 23 Feb 2016
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 12678355Holt 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.
PubMed 9415907Palmieri-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.
PubMed 23672382Pietrosimone 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.
PubMed 25062605
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Following Suction Drain and Non-suction Drain Assisted Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02693457
- Acronym / sponsor ID
- 1541
- Conditions
- Osteoarthritis, Bilateral Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Colorado Joint ReplacementUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, CommonSpirit Health
- Study start
- Feb 2016 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drain | Active comparator | Procedure: DrainIntra-articular drain will be placed at closure of randomized knee for 24 hours |
| No Drain | Experimental | Procedure: No DrainNo 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. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≤ 70 years
- Undergoing bilateral, simultaneous, primary knee replacements
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DrainOne 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. | Procedure or surgery | Drain |
| No DrainThe 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. | Procedure or surgery | No Drain |
Primary outcome
Lower Extremity Isomechanical Dynomometery
Time frame: 2 Weeks Post-Operative
Knee Extensor Strength
51 secondary outcomes
Lower Extremity Isomechanical Dynomometery
Time frame: Pre-Operative
Lower Extremity Hand Held Dyanmometry
Time frame: 48 hours Post-Operative
Lower Extremity Isomechanical Dynomometery
Time frame: 6 Weeks Post-Operative
Lower Extremity Isomechanical Dynomometery
Time frame: 3 Month Post-Operative
Clinical Quadriceps Activation Battery
Time frame: Pre-Operative
Clinical Quadriceps Activation Battery
Time frame: 8 hours Post-Operative
Clinical Quadriceps Activation Battery
Time frame: 24 hours Post-Operative
Clinical Quadriceps Activation Battery
Time frame: 48 Hours Post-Operative
Clinical Quadriceps Activation Battery
Time frame: 2 weeks Post-Operative
Clinical Quadriceps Activation Battery
Time frame: 6 weeks Post-Operative
Clinical Quadriceps Activation Battery
Time frame: 3 Months Post-Operative
Bioelectrical Impedance for Swelling
Time frame: Pre-Operative
Bioelectrical Impedance for Swelling
Time frame: 8 hours Post-Operative
Bioelectrical Impedance for Swelling
Time frame: 24 hours Post-Operative
Bioelectrical Impedance for Swelling
Time frame: 48 Hours Post-Operative
Bioelectrical Impedance for Swelling
Time frame: 2 Weeks Post-Operative
Bioelectrical Impedance for Swelling
Time frame: 6 Weeks Post-Operative
Bioelectrical Impedance for Swelling
Time frame: 3 Months Post-Operative
Circumferential Measure of Swelling
Time frame: Pre-Operative
Circumferential Measure of Swelling
Time frame: 8 hours Post-Operative
Circumferential Measure of Swelling
Time frame: 24 hours Post-Operative
Circumferential Measure of Swelling
Time frame: 48 Hours Post-Operative
Circumferential Measure of Swelling
Time frame: 2 Weeks Post-Operative
Circumferential Measure of Swelling
Time frame: 6 Weeks Post-Operative
Circumferential Measure of Swelling
Time frame: 3 Months Post-Operative
Diagnostic Ultrasound Measure of Effusion
Time frame: Pre-Operative
Diagnostic Ultrasound Measure of Effusion
Time frame: 48 Hours Post-Operative
Diagnostic Ultrasound Measure of Effusion
Time frame: 2 Weeks Post-Operative
Diagnostic Ultrasound Measure of Effusion
Time frame: 6 Weeks Post-Operative
Diagnostic Ultrasound Measure of Effusion
Time frame: 3 Months Post-Operative
Knee Pain Measured by Visual Analog Scale
Time frame: Pre-Operative
Knee Pain Measured by Visual Analog Scale
Time frame: 8 Hours Post-Operative
Knee Pain Measured by Visual Analog Scale
Time frame: 24 Hours Post-Operative
Knee Pain Measured by Visual Analog Scale
Time frame: 48 Hours Post-Operative
Knee Pain Measured by Visual Analog Scale
Time frame: 2 Weeks Post-Operative
Knee Pain Measured by Visual Analog Scale
Time frame: 6 Weeks Post-Operative
Knee Pain Measured by Visual Analog Scale
Time frame: 3 Months Post-Operative
Knee Flexion Range of Motion
Time frame: Pre-Operative
Knee Flexion Range of Motion
Time frame: 8 Hours Post-Operative
Knee Flexion Range of Motion
Time frame: 24 Hours Post-Operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Background: PubMed 12678355Esler 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.
- Background: PubMed 9415907Holt 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.
- Background: PubMed 23672382Palmieri-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.
- Background: PubMed 25062605Pietrosimone 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.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Jennings, MD principal investigator
Colorado Joint Replacement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drain and No Drain in people with Osteoarthritis and Bilateral Total Knee Arthroplasty, run by Colorado Joint Replacement at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Extremity Isomechanical Dynomometery (time frame: 2 Weeks Post-Operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02693457, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.