Arthritis Knee
Conditions
Brief summary
The purpose of this study is determine the effect on novel pressure-regulating tourniquet use on pain, functional recovery, sleep and total blood loss following total knee arthroplasty.
Detailed description
Functional recovery after total knee arthroplasty (TKA) has seen dramatic improvement over the past 20 years through advances in surgical technique, implant design, perioperative pain management strategies, and physical therapy protocols. Tourniquet use during TKA, however, remains controversial due to conflicting reports in the literature on these benefits and risks of its use. Reported advantages of tourniquet use include improved visualization of the surgical field and decreased intraoperative blood loss. Reported disadvantages of tourniquet use include increased postoperative pain and slower functional recovery as a direct result of the pressure of the tourniquet on the thigh during the procedure. Traditionally with tourniquet use during TKA, the limb is exsanguinated and the tourniquet is raised to a fixed, pressure at the beginning of the case, typically 250mmHg to 350mmHg, and let down after closure. A novel tourniquet design that adjusts the tourniquet pressure in real-time based on intraoperative patient blood pressure measurements. This design may allow for the tourniquet to be inflated at a lower mean pressure while still maintaining efficacy. A prospective study comparing total blood loss, pain and functional recovery after TKA using this novel tourniquet design, design (Zimmer A.T.S.® 4000TS Automatic Tourniquet System, with disposable contour cuffs) and TKA without tourniquet would further the current literature. Total blood loss will be calculated by previously validated methods. Pain and functional recovery will be closely monitored throughout the postoperative period using a patient wearable activity tracker (FitBit Inspire HR) and a smartphone-based patient engagement platform with integrated digital surveys paired with smart-brace based home PT assessments (FocusMotion).Pain and functional recovery will be closely monitored throughout the postoperative period using a patient wearable activity tracker (FitBit Inspire HR) and a smartphone-based patient engagement platform with integrated digital surveys paired with smart-brace based home PT assessments (FocusMotion). Applying this technology to the proposed study can help identify problematic pain that is not appreciable during admission; given the fact that markers of inflammation and myocyte damage increase over time until at least post-operative day 3, it is possible that TKAs performed under tourniquet may have pain and narcotic requirements not appreciated with short-stay admissions . The proposed study will further the literature on pain and narcotic use in the early time period after TKA, and will help identify if tourniquet has an effect on these variables. Furthermore, sleep quality is a component of functional recovery and is correlated with pain. Knee osteoarthritis affects general quality of life by increasing sleep disturbance and nighttime wakening, and this is correlated with the pre-operative radiographic severity of disease. Sleep quality is affected in the immediate post-operative period after TKA as well, but improves by 3-6 months post-operatively . The proposed study would be the largest prospective study investigating the effect of TKA on pain and sleep quality, as well as being the first to investigate tourniquet use as a factor affecting sleep quality and pain. The proposed study would be the first to collect both subjective and objective data on the subject, using validated survey measurements as well as the data collected by the Fitbit Inspire HR device.
Interventions
tourniquet is a device used during total knee surgery.
tourniquet is a device used during total knee surgery, this group does not get one
Sponsors
Study design
Masking description
Participants do not know which group they are in.
Intervention model description
Patients are put into 2 study groups. One group gets a tourniquet during surgery and one group does not.
Eligibility
Inclusion criteria
* Age 18 and up * Primary unilateral TKA * BMI\<45 * Primary diagnosis of osteoarthritis * Patient has a iOS or Android smartphone capable of running FitBit and FocusMotion applications
Exclusion criteria
* Revision TKA * Bilateral TKA * Pregnancy * Prisoners * Pre-existing functionally-limiting neurologic disorder * Narcotic dependence, defined as oxycodone/hydrocodone use \>5days/week * History of unprovoked VTE/PE * Inability to complete baseline functional testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain After TKA Measured by VAS Pain Survey on Focusmotion App | 1 year | Effect of tourniquet use on pain after TKA, 0-10 scale with 10 being higher pain, VAS pain survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Recovery Measured by Oxford Knee Score Scale | 1 year | Effect of tourniquet use on functional recovery after TKA. Score each question (item) from 0 to 4 with 0 being the worst outcome and 4 being the best outcome. The scores are then summed to produce an overall score running from 0 (worst possible) to 48 (best outcome). |
| Functional Recovery Measured by Forgotten Joint Score | 1 year | Effect of tourniquet use on functional recovery after TKA. Scale measures how much patient is aware of their joint after surgery. a total of 12 questions are answered asking about awareness of the knee joint. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. Final score = 100 - ((sum(item01 to item12) - 12)/48\*100) 0:Represents the worst possible score, indicating the highest level of joint awareness and the least ability to forget. 100:Represents the best possible score, indicating the lowest level of joint awareness and the greatest ability to forget |
| Functional Recovery Measured by Normal Knee Survey | 1 year | Effect of tourniquet use on functional recovery after TKA measured by a score of 0-100, 100 being knee feels normal, 0 means knee does not feel normal |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hours of Sleep Per Night Postoperatively | 3 months | Investigate sleep quality in post-operative period after TKA using fitbit tracker average hours of sleep at night |
| Total Blood Loss | 1 day | effect of tourniquet use on total calculated blood loss after TKA. this is calculated by change in hemoglobin in g/dL from preop to periop. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tourniquet During Surgery Patients in this group get a tourniquet during surgery.
tourniquet: tourniquet is a device used during total knee surgery. | 57 |
| No Tourniquet During Surgery Patients in this group do not get a tourniquet during surgery.
No tourniquet: tourniquet is a device used during total knee surgery, this group does not get one | 58 |
| Total | 115 |
Baseline characteristics
| Characteristic | No Tourniquet During Surgery | Total | Tourniquet During Surgery |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 33 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 82 Participants | 43 Participants |
| Age, Continuous | 64.6 years | 64 years | 63.4 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 58 participants | 115 participants | 57 participants |
| Sex: Female, Male Female | 34 Participants | 56 Participants | 22 Participants |
| Sex: Female, Male Male | 24 Participants | 59 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 57 | 0 / 58 |
| other Total, other adverse events | 0 / 57 | 0 / 58 |
| serious Total, serious adverse events | 1 / 57 | 0 / 58 |
Outcome results
Pain After TKA Measured by VAS Pain Survey on Focusmotion App
Effect of tourniquet use on pain after TKA, 0-10 scale with 10 being higher pain, VAS pain survey
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tourniquet During Surgery | Pain After TKA Measured by VAS Pain Survey on Focusmotion App | 2.8 score on a scale | Standard Deviation 1.5 |
| No Tourniquet During Surgery | Pain After TKA Measured by VAS Pain Survey on Focusmotion App | 2.6 score on a scale | Standard Deviation 1.8 |
Functional Recovery Measured by Forgotten Joint Score
Effect of tourniquet use on functional recovery after TKA. Scale measures how much patient is aware of their joint after surgery. a total of 12 questions are answered asking about awareness of the knee joint. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. Final score = 100 - ((sum(item01 to item12) - 12)/48\*100) 0:Represents the worst possible score, indicating the highest level of joint awareness and the least ability to forget. 100:Represents the best possible score, indicating the lowest level of joint awareness and the greatest ability to forget
Time frame: 1 year
Population: not all patients completed this survey, that is why the numbers are inconsistent with other surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tourniquet During Surgery | Functional Recovery Measured by Forgotten Joint Score | 68.4 score on a scale | Standard Deviation 28.2 |
| No Tourniquet During Surgery | Functional Recovery Measured by Forgotten Joint Score | 70.9 score on a scale | Standard Deviation 77.4 |
Functional Recovery Measured by Normal Knee Survey
Effect of tourniquet use on functional recovery after TKA measured by a score of 0-100, 100 being knee feels normal, 0 means knee does not feel normal
Time frame: 1 year
Population: not all patients completed this survey, that is why participant numbers are inconsistent with other surveys
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tourniquet During Surgery | Functional Recovery Measured by Normal Knee Survey | 79.3 score on a scale | Standard Deviation 90 |
| No Tourniquet During Surgery | Functional Recovery Measured by Normal Knee Survey | 81.5 score on a scale | Standard Deviation 20.1 |
Functional Recovery Measured by Oxford Knee Score Scale
Effect of tourniquet use on functional recovery after TKA. Score each question (item) from 0 to 4 with 0 being the worst outcome and 4 being the best outcome. The scores are then summed to produce an overall score running from 0 (worst possible) to 48 (best outcome).
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tourniquet During Surgery | Functional Recovery Measured by Oxford Knee Score Scale | 43.0 score on a scale | Standard Deviation 6.28 |
| No Tourniquet During Surgery | Functional Recovery Measured by Oxford Knee Score Scale | 41.37 score on a scale | Standard Deviation 8.84 |
Hours of Sleep Per Night Postoperatively
Investigate sleep quality in post-operative period after TKA using fitbit tracker average hours of sleep at night
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tourniquet During Surgery | Hours of Sleep Per Night Postoperatively | 5.41 hours of sleep | Standard Deviation 2.23 |
| No Tourniquet During Surgery | Hours of Sleep Per Night Postoperatively | 6.47 hours of sleep | Standard Deviation 1.63 |
Total Blood Loss
effect of tourniquet use on total calculated blood loss after TKA. this is calculated by change in hemoglobin in g/dL from preop to periop.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tourniquet During Surgery | Total Blood Loss | 13.9 g/dL hemoglobin | Standard Deviation 1.4 |
| No Tourniquet During Surgery | Total Blood Loss | 11.5 g/dL hemoglobin | Standard Deviation 1.3 |