Trial Outcomes & Findings for A Prospective Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device (NCT NCT01704157)

NCT ID: NCT01704157

Last Updated: 2024-01-24

Results Overview

Visual Analog Scale(VAS), where a higher score indicates greater intensity; 0= no pain, 10=worst pain

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: Baseline to Day 7
• Results posted on: 2024-01-24

Participant Flow

Subjects were prospectively enrolled at 2 sites. Enrollment was initiated September 18, 2012 and completed March 25, 2013.

Participant milestones

Measure	Open Treatment Treatment with Cryo-Touch III Device
Overall Study STARTED	33
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Prospective Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device

Baseline characteristics by cohort

Measure	Open Treatment n=33 Participants Cryo-Touch III Device
Age, Continuous	55.9 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Gender · Female	12 Participants n=5 Participants
Sex: Female, Male Gender · Male	21 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants
Average Baseline Pain Score- Visual Analog Scale (VAS)	6.3 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants
Average Baseline Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale	125.8 units on a scale STANDARD_DEVIATION 42.8 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 7

Visual Analog Scale(VAS), where a higher score indicates greater intensity; 0= no pain, 10=worst pain

Outcome measures

Measure	Open Treatment n=33 Participants Cryo-Touch III Device
Average Improvement in VAS Pain Score From Baseline to Day 7	2.2 score on a scale Standard Deviation 2.2

PRIMARY outcome

Timeframe: Baseline to Day 7

The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale.

A tri-dimensional, disease-specific, patient-reported outcome measure. Consists of 24 questions: 5 pain, 2 stiffness and 17 function. Each category contains a set of questions rated by the Subject on a 0-10 scale;

The highest possible score was 50 for pain, 20 for stiffness and 170 for function, based on the 0-10 scale used to assess each question.

The total score range is 0 to 240 with higher scores correlating to worse outcomes.

Outcome measures

Measure	Open Treatment n=33 Participants Cryo-Touch III Device
Improvement in WOMAC Index From Baseline to Day 7	85.7 score on a scale Standard Deviation 53.4

SECONDARY outcome

Timeframe: Visit 3 (Day 7), Visit 4 (Day 30), Visit 5 (Day 56)

Subjects were asked to report whether they experienced continued treatment effect at the timepoints indicated.

Outcome measures

Measure	Open Treatment n=33 Participants Cryo-Touch III Device
Number of Participants Who Experienced Continued Treatment Effect at Each Time Point Day 7	31 Participants
Number of Participants Who Experienced Continued Treatment Effect at Each Time Point Day 30	28 Participants
Number of Participants Who Experienced Continued Treatment Effect at Each Time Point Day 56	23 Participants

Adverse Events

Open Treatment

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Open Treatment n=33 participants at risk Cryo-Touch III Device
Infections and infestations Tuberculosis	3.0% 1/33 • Number of events 1 • Adverse events were collected from treatment day through Day 140

Other adverse events

Measure	Open Treatment n=33 participants at risk Cryo-Touch III Device
Nervous system disorders Right leg numbness	3.0% 1/33 • Number of events 1 • Adverse events were collected from treatment day through Day 140
Injury, poisoning and procedural complications nausea duringprocedure	3.0% 1/33 • Number of events 1 • Adverse events were collected from treatment day through Day 140
Infections and infestations Seasonal Cold	3.0% 1/33 • Number of events 1 • Adverse events were collected from treatment day through Day 140
Skin and subcutaneous tissue disorders Arm Laceration	3.0% 1/33 • Number of events 1 • Adverse events were collected from treatment day through Day 140
Musculoskeletal and connective tissue disorders Tenderness to palpation in thigh	3.0% 1/33 • Number of events 1 • Adverse events were collected from treatment day through Day 140
Musculoskeletal and connective tissue disorders clicking sound in knee with standing	3.0% 1/33 • Number of events 1 • Adverse events were collected from treatment day through Day 140
Nervous system disorders tingling/pain in feet	3.0% 1/33 • Number of events 1 • Adverse events were collected from treatment day through Day 140
Nervous system disorders Left Leg numbness	3.0% 1/33 • Number of events 1 • Adverse events were collected from treatment day through Day 140
Musculoskeletal and connective tissue disorders Pain/loss of full range of motion with pivot	3.0% 1/33 • Number of events 1 • Adverse events were collected from treatment day through Day 140

Additional Information

Pacira MedInfo

Pacira Bioscience, Inc.

Phone: 1-855-793-9729

Email: MedInfo@Pacira.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER