Tourniquet vs. Short Time Tourniquet in Primary Robotic Assisted TKA

Knee Arthropathy Clinical Trial

Official title:

Is TKA With Short Tourniquet Time Superior to TKA With Tourniquet Use in Primary Robotic Assisted TKA? A Prospective, Randomized Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03942939
• Other study ID #: 19.0365
• Status: Completed
• Phase: N/A
• Start date: August 27, 2019
• Est. completion date: July 15, 2020

Study information

• Verified date: November 2020
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this prospective, randomized study is to compare the outcomes of patients undergoing Robotic Arm-Assisted TKA (RA-TKA) with the intraoperative use of a tourniquet to those undergoing RA-TKA with a short tourniquet time.

Description:

The goal of this prospective, randomized study is to compare the outcomes of patients undergoing Robotic Arm-Assisted TKA (RA-TKA) with the intraoperative use of a tourniquet to those undergoing RA-TKA with a short tourniquet time. The primary objectives will be to compare the total duration of hospital stay, quadriceps function, and the amount of postoperative narcotics utilized and VAS pain levels. The secondary objective will be to compare variables of patient functionality at five postoperative intervals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 15, 2020
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Patient is over the age of 21

2. Patient is scheduled to undergo a unilateral, cementless primary RA-TKA, secondary to osteoarthritis

3. Surgical approach is subvastus approach

4. Patient's BMI (body mass index) is less than 40 at time of surgery.

5. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization documents

6. Patient is able to read and speak English

Exclusion Criteria:

1. Patient is under the age of 21

2. Patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis)

3. Patient is scheduled to undergo a bilateral TKA surgery

4. Patient BMI is > 40

5. Patient is unable to read and speak English

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy

Intervention

Other:
• Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time
Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time. Short tourniquet time is defined in this study as the release of the tourniquet after the initial exposure, resulting in a total tourniquet time of only 10-15 minutes.
• Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet
Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet

Locations

Country	Name	City	State
United States	Jewish Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Score	Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.	outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
Primary	Knee Society Score	Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.	outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Primary	Knee Society Score	Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.	outcome measure will be taken 1 year (± 2 months) postoperatively
Primary	WOMAC Score	WOMAC score. The score is on a scale from 0-100. In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome.	outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
Primary	WOMAC Score	WOMAC score. The score is on a scale from 0-100. In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome.	outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Primary	WOMAC Score	WOMAC score. The score is on a scale from 0-100. In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome.	outcome measure will be taken 1 year (± 2 months) postoperatively
Primary	Active range-of-motion (ROM)	Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)	outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
Primary	Active range-of-motion (ROM)	Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)	outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Primary	Active range-of-motion (ROM)	Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)	outcome measure will be taken 1 year (± 2 months) postoperatively
Primary	Amount of narcotic medication utilized	Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).	outcome measure will be taken 24 hours postoperatively
Primary	Amount of narcotic medication utilized	Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).	outcome measure will be taken 48 hours postoperatively
Primary	Amount of narcotic medication utilized	Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).	outcome measure will be taken 72 hours postoperatively
Primary	Amount of narcotic medication utilized	Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).	outcome measure will be taken 2 weeks (± 4 days) postoperatively
Primary	Amount of narcotic medication utilized	Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).	outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Primary	Visual Analog Scale	The Visual Analog Scale measures the patient's level of knee pain on a scale of zero to ten via what the patient expresses verbally. The Visual Analog Scale (VAS) represents the degree of pain that the patient is experiencing at the time the measure is taken. Zero represents "pain-free". A 10 would represent pain so excruciating as to warrant emergency medical assistance, or as it is described to the patient, "the worst pain imaginable". Obviously, the lower the number, the better the outcome. There is no subscale.	outcome measure will be taken 24 hours postoperatively
Primary	Visual Analog Scale	The Visual Analog Scale measures the patient's level of knee pain on a scale of zero to ten via what the patient expresses verbally. The Visual Analog Scale (VAS) represents the degree of pain that the patient is experiencing at the time the measure is taken. Zero represents "pain-free". A 10 would represent pain so excruciating as to warrant emergency medical assistance, or as it is described to the patient, "the worst pain imaginable". Obviously, the lower the number, the better the outcome. There is no subscale.	outcome measure will be taken 48 hours postoperatively
Primary	Visual Analog Scale	The Visual Analog Scale measures the patient's level of knee pain on a scale of zero to ten via what the patient expresses verbally. The Visual Analog Scale (VAS) represents the degree of pain that the patient is experiencing at the time the measure is taken. Zero represents "pain-free". A 10 would represent pain so excruciating as to warrant emergency medical assistance, or as it is described to the patient, "the worst pain imaginable". Obviously, the lower the number, the better the outcome. There is no subscale.	outcome measure will be taken 72 hours postoperatively
Primary	Visual Analog Scale	The Visual Analog Scale measures the patient's level of knee pain on a scale of zero to ten via what the patient expresses verbally. The Visual Analog Scale (VAS) represents the degree of pain that the patient is experiencing at the time the measure is taken. Zero represents "pain-free". A 10 would represent pain so excruciating as to warrant emergency medical assistance, or as it is described to the patient, "the worst pain imaginable". Obviously, the lower the number, the better the outcome. There is no subscale.	outcome measure will be taken 2 weeks (± 4 days) postoperatively
Primary	Visual Analog Scale	The Visual Analog Scale measures the patient's level of knee pain on a scale of zero to ten via what the patient expresses verbally. The Visual Analog Scale (VAS) represents the degree of pain that the patient is experiencing at the time the measure is taken. Zero represents "pain-free". A 10 would represent pain so excruciating as to warrant emergency medical assistance, or as it is described to the patient, "the worst pain imaginable". Obviously, the lower the number, the better the outcome. There is no subscale.	outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Primary	Distance that patient is able to walk	Distance that patient is able to walk, as measured in feet	outcome measure will be taken 24 hours postoperatively
Primary	Distance that patient is able to walk	Distance that patient is able to walk, as measured in feet	outcome measure will be taken 48 hours postoperatively
Primary	Distance that patient is able to walk	Distance that patient is able to walk, as measured in feet	outcome measure will be taken 72 hours postoperatively
Primary	Distance that patient is able to walk	Distance that patient is able to walk, as measured in feet	outcome measure will be taken 2 weeks (± 4 days) postoperatively
Primary	Distance that patient is able to walk	Distance that patient is able to walk, as measured in feet	outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Primary	Ability to rise from a chair independently	Ability to rise from a chair independently (Yes/No)	outcome measure will be taken 24 hours postoperatively
Primary	Ability to rise from a chair independently	Ability to rise from a chair independently (Yes/No)	outcome measure will be taken 48 hours postoperatively
Primary	Ability to rise from a chair independently	Ability to rise from a chair independently (Yes/No)	outcome measure will be taken 72 hours postoperatively
Primary	Ability to rise from a chair independently	Ability to rise from a chair independently (Yes/No)	outcome measure will be taken 2 weeks (± 4 days) postoperatively
Primary	Ability to rise from a chair independently	Ability to rise from a chair independently (Yes/No)	outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Primary	Use of an ambulatory assistive device	Use of an ambulatory assistive device (Yes/No)	outcome measure will be taken 24 hours postoperatively
Primary	Use of an ambulatory assistive device	Use of an ambulatory assistive device (Yes/No)	outcome measure will be taken 48 hours postoperatively
Primary	Use of an ambulatory assistive device	Use of an ambulatory assistive device (Yes/No)	outcome measure will be taken 72 hours postoperatively
Primary	Use of an ambulatory assistive device	Use of an ambulatory assistive device (Yes/No)	outcome measure will be taken 2 weeks (± 4 days) postoperatively
Primary	Use of an ambulatory assistive device	Use of an ambulatory assistive device (Yes/No)	outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Primary	Return to driving	Return to driving (Yes/No)	outcome measure will be taken 2 weeks (± 4 days) postoperatively
Primary	Return to driving	Return to driving (Yes/No)	outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Primary	Level of Patient Satisfaction: 5-point Likert scale	Level of Patient Satisfaction as measured using a 5-point Likert scale	outcome measure will be taken at 6 weeks (± 2 weeks) postoperatively.
Primary	Level of Patient Satisfaction: 5-point Likert scale	Level of Patient Satisfaction as measured using a 5-point Likert scale	outcome measure will be taken 1 year (± 2 months) postoperatively
Primary	Quadriceps Function	Quadriceps Function as measured in peak force in kilograms by a Hand-held dynamometer (model 01163; Lafayette Instrument Company, Lafayette, Ind., USA)	outcome measure will be taken at 2 weeks (± 4 days)
Primary	Quadriceps Function	Quadriceps Function as measured in peak force in kilograms by a Hand-held dynamometer (model 01163; Lafayette Instrument Company, Lafayette, Ind., USA)	outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Primary	Quadriceps Function	Quadriceps Function as measured in peak force in kilograms by a Hand-held dynamometer (model 01163; Lafayette Instrument Company, Lafayette, Ind., USA)	outcome measure will be taken 1 year (± 2 months) postoperatively
Primary	total length of hospital stay	total length of hospital stay as defined by number of days from date of surgery to date of discharge	outcome measure will be taken at 2 weeks postoperatively
Primary	Dates of postoperative exams	Dates of postoperative exams as defined by dates that subject returns to the P.I.'s office for postoperative exam	outcome measure will be taken at 2 weeks (± 4 days) postoperatively
Primary	Dates of postoperative exams	Dates of postoperative exams as defined by dates that subject returns to the P.I.'s office for postoperative exam	outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Primary	Dates of postoperative exams	Dates of postoperative exams as defined by dates that subject returns to the P.I.'s office for postoperative exam	outcome measure will be taken 1 year (± 2 months) postoperatively
Primary	Incidence of postop transfusion	Incidence of postop transfusion as defined by one or more transfusions of blood to the subject postoperatively	outcome measure will be taken at 2 weeks postoperatively
Primary	Change in creatinine level (CKMB)	Change in CKMB (creatinine level) as defined by the CKMB values recorded in the participant's lab report	outcome measures will be taken preoperatively (4-6 weeks prior to date of surgery) and on postoperative day number two.
Primary	Change in hemoglobin level (HgB)	Change in HgB as defined by the HgB values recorded in the participant's lab report	outcome measures will be taken preoperatively (4-6 weeks prior to date of surgery) and on postoperative day number two.
Primary	Operative Time	Total Operative Time as defined in minutes	outcome measure will be taken at 2 weeks postoperatively
Primary	Estimated Blood Loss (EBL)	Estimated Blood Loss as defined by the amount of intraoperative blood loss measured in cubic centimeters (cc).	outcome measure will be taken at 2 weeks postoperatively
Secondary	Number of Participants with postoperative complications	Number of Participants with postoperative complications. A postoperative complication is defined as any diagnosis or condition that necessitates a re-operation on the surgical knee	outcome measure will be taken at 1 year (± 2 months) postoperatively