Trial Outcomes & Findings for Tourniquet on Total Knee Arthroplasty (NCT NCT04923724)

Results Overview

Effect of tourniquet use on pain after TKA, 0-10 scale with 10 being higher pain, VAS pain survey

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

165 participants

Primary outcome timeframe

1 year

Results posted on

2025-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Tourniquet During Surgery Patients in this group get a tourniquet during surgery. tourniquet: tourniquet is a device used during total knee surgery.	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
Overall Study STARTED	82	83
Overall Study COMPLETED	57	58
Overall Study NOT COMPLETED	25	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tourniquet During Surgery n=57 Participants Patients in this group get a tourniquet during surgery. tourniquet: tourniquet is a device used during total knee surgery.	No Tourniquet During Surgery n=58 Participants 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	Total n=115 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=57 Participants	0 Participants n=58 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=57 Participants	39 Participants n=58 Participants	82 Participants n=115 Participants
Age, Categorical >=65 years	14 Participants n=57 Participants	19 Participants n=58 Participants	33 Participants n=115 Participants
Age, Continuous	63.4 years n=57 Participants	64.6 years n=58 Participants	64 years n=115 Participants
Sex: Female, Male Female	22 Participants n=57 Participants	34 Participants n=58 Participants	56 Participants n=115 Participants
Sex: Female, Male Male	35 Participants n=57 Participants	24 Participants n=58 Participants	59 Participants n=115 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	57 participants n=57 Participants	58 participants n=58 Participants	115 participants n=115 Participants

PRIMARY outcome

Timeframe: 1 year

Effect of tourniquet use on pain after TKA, 0-10 scale with 10 being higher pain, VAS pain survey

Outcome measures

Outcome measures
Measure	Tourniquet During Surgery n=58 Participants Patients in this group get a tourniquet during surgery. tourniquet: tourniquet is a device used during total knee surgery.	No Tourniquet During Surgery n=57 Participants 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
Pain After TKA Measured by VAS Pain Survey on Focusmotion App	2.8 score on a scale Standard Deviation 1.5	2.6 score on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Tourniquet During Surgery n=58 Participants Patients in this group get a tourniquet during surgery. tourniquet: tourniquet is a device used during total knee surgery.	No Tourniquet During Surgery n=57 Participants 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
Functional Recovery Measured by Oxford Knee Score Scale	43.0 score on a scale Standard Deviation 6.28	41.37 score on a scale Standard Deviation 8.84

SECONDARY outcome

Timeframe: 1 year

Population: not all patients completed this survey, that is why the numbers are inconsistent with other surveys.

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

Outcome measures

Outcome measures
Measure	Tourniquet During Surgery n=47 Participants Patients in this group get a tourniquet during surgery. tourniquet: tourniquet is a device used during total knee surgery.	No Tourniquet During Surgery n=40 Participants 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
Functional Recovery Measured by Forgotten Joint Score	68.4 score on a scale Standard Deviation 28.2	70.9 score on a scale Standard Deviation 77.4

SECONDARY outcome

Timeframe: 1 year

Population: not all patients completed this survey, that is why participant numbers are inconsistent with other surveys

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

Outcome measures

Outcome measures
Measure	Tourniquet During Surgery n=45 Participants Patients in this group get a tourniquet during surgery. tourniquet: tourniquet is a device used during total knee surgery.	No Tourniquet During Surgery n=39 Participants 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
Functional Recovery Measured by Normal Knee Survey	79.3 score on a scale Standard Deviation 90	81.5 score on a scale Standard Deviation 20.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Investigate sleep quality in post-operative period after TKA using fitbit tracker average hours of sleep at night

Outcome measures

Outcome measures
Measure	Tourniquet During Surgery n=41 Participants Patients in this group get a tourniquet during surgery. tourniquet: tourniquet is a device used during total knee surgery.	No Tourniquet During Surgery n=28 Participants 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
Hours of Sleep Per Night Postoperatively	5.41 hours of sleep Standard Deviation 2.23	6.47 hours of sleep Standard Deviation 1.63

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Tourniquet During Surgery n=54 Participants Patients in this group get a tourniquet during surgery. tourniquet: tourniquet is a device used during total knee surgery.	No Tourniquet During Surgery n=53 Participants 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
Total Blood Loss	13.9 g/dL hemoglobin Standard Deviation 1.4	11.5 g/dL hemoglobin Standard Deviation 1.3

Adverse Events

Tourniquet During Surgery

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

No Tourniquet During Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tourniquet During Surgery n=57 participants at risk Patients in this group get a tourniquet during surgery. tourniquet: tourniquet is a device used during total knee surgery.	No Tourniquet During Surgery n=58 participants at risk 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
Hepatobiliary disorders urinary retention lower abdominal and back pain	1.8% 1/57 • Number of events 1 • Ae's collected up to 1 year. the adverse events were not caused by the study	0.00% 0/58 • Ae's collected up to 1 year. the adverse events were not caused by the study

Other adverse events

Adverse event data not reported

Additional Information

Venessa Riegler

Washington University School of Medicine

Phone: 314-362-1721

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place