Trial Outcomes & Findings for Cryoneurolysis for Improvements in Pain, ADL and QOL in Patients With Ankle Osteoarthritis (NCT NCT03567187)

NCT ID: NCT03567187

Last Updated: 2024-05-16

Results Overview

FAOS-Pain is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score.The sub scale ranges from 0 to 100 where higher values represents a better outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Change between baseline/screening and 12-weeks following treatment
• Results posted on: 2024-05-16

Participant Flow

Forty-three potentially eligible participants were screened. Of these two were found by radiographs or weight-bearing CT (WBCT) scan to not have tibiotalar osteoarthritis (KL=0) and were excluded. In addition, one participant was excluded due to an unstable ankle that resulted in bracing and opioid therapy. Subsequently, 40 participants with unilateral painful ankle OA were recruited.

Participant milestones

Measure	Iovera The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.
Overall Study STARTED	40
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Measure

Iovera The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.

Overall Study Lost to Follow-up

18

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Iovera n=40 Participants The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.
Age, Continuous	63.0 years STANDARD_DEVIATION 12.8 • n=40 Participants
Sex: Female, Male Female	20 Participants n=40 Participants
Sex: Female, Male Male	20 Participants n=40 Participants
Region of Enrollment United States	40 participants n=40 Participants
NRS Pain Score	6.3 units on a scale STANDARD_DEVIATION 1.6 • n=40 Participants
FAOS-Pain	43.1 units on a scale STANDARD_DEVIATION 14.1 • n=40 Participants
BMI	31.7 kg/m^2 STANDARD_DEVIATION 6.8 • n=40 Participants
Index ankle joint, n (% right )	27 Participants n=40 Participants
FAOS-ADL	53.3 units on a scale STANDARD_DEVIATION 16.4 • n=40 Participants
FAOS-QOL	22.0 units on a scale STANDARD_DEVIATION 16.9 • n=40 Participants
40-meter fast-paced walking test	32.8 sec STANDARD_DEVIATION 9.2 • n=40 Participants

PRIMARY outcome

Timeframe: Change between baseline/screening and 12-weeks following treatment

Population: Twenty seven eligible participants completed 12-weeks follow-up treatment

FAOS-Pain is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score.The sub scale ranges from 0 to 100 where higher values represents a better outcome.

Outcome measures

Measure

Iovera n=27 Participants The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.

FAOS - PAIN

20.8 score on a scale Standard Error 4.5

SECONDARY outcome

Timeframe: change between baseline/screening and 6-weeks following treatment

Population: Thirty five eligible participants completed 6-weeks follow-up treatment

The Numeric Rating Scale (NRS) is a numeric scale to rates the pain from 0 (no pain) to 10 (worst pain).

Outcome measures

Measure

Iovera n=35 Participants The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.

NRS Pain Over Prior 7 Days

-2.7 score on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: change between baseline/screening and 12-weeks following treatment

Population: Twenty seven eligible participants completed 12-weeks follow-up treatment

FAOS - ADL(Activity of daily living) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - ADL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome.

Outcome measures

Measure

Iovera n=27 Participants The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.

FAOS - ADL(Activity of Daily Living)

18.1 score on a scale Standard Error 4.9

SECONDARY outcome

Timeframe: change between baseline/screening and 6-weeks following treatment

Population: Thirty five eligible participants completed 6-weeks follow-up treatment

FAOS - ADL(Activity of daily living) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - ADL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome.

Outcome measures

Measure

Iovera n=35 Participants The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.

FAOS - ADL(Activity of Daily Living)

16.6 score on a scale Standard Error 4.3

SECONDARY outcome

Timeframe: change between baseline/screening and 24-weeks following treatment

Population: Twenty two eligible participants completed 24-weeks follow-up treatment

FAOS - ADL(Activity of daily living) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - ADL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome.

Outcome measures

Measure

Iovera n=22 Participants The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.

FAOS - ADL(Activity of Daily Living)

20.1 score on a scale Standard Error 4.1

SECONDARY outcome

Timeframe: change between baseline/screening and 12-weeks following treatment

Population: Twenty seven eligible participants completed 12-weeks follow-up treatment

FAOS-QoL(Quality of life) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - QoL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome.

Outcome measures

Measure

Iovera n=27 Participants The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.

FAOS-QoL(Quality of Life)

19.9 score on a scale Standard Error 5.3

SECONDARY outcome

Timeframe: change between baseline/screening and 6-weeks following treatment

Population: Thirty five eligible participants completed 6-weeks follow-up treatment

FAOS-QoL(Quality of life) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - QoL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome.

Outcome measures

Measure

Iovera n=35 Participants The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.

FAOS-QoL(Quality of Life)

22.4 score on a scale Standard Error 4.4

SECONDARY outcome

Timeframe: change between baseline/screening and 24-weeks following treatment

Population: Twenty two eligible participants completed 24-weeks follow-up treatment

FAOS-QoL(Quality of life) is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score. It is similar to the KOOS - QoL components.The sub scale ranges from 0 to 100 where higher values represents a better outcome.

Outcome measures

Measure

Iovera n=22 Participants The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.

FAOS-QoL(Quality of Life)

25.4 score on a scale Standard Error 4.8

SECONDARY outcome

Timeframe: change between baseline/screening and 6-weeks following treatment

Population: Thirty five eligible participants completed 6-weeks follow-up treatment

FAOS-Pain is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score.The sub scale ranges from 0 to 100 where higher values represents a better outcome.

Outcome measures

Measure

Iovera n=35 Participants The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.

FAOS - PAIN

17.4 score on a scale Standard Error 4.1

SECONDARY outcome

Timeframe: change between baseline/screening and 24-weeks following treatment

Population: Twenty two eligible participants completed 24-weeks follow-up treatment

FAOS-Pain is a subscale of the Foot and ankle outcome score (FAOS) which is a self-reported outcome score.The sub scale ranges from 0 to 100 where higher values represents a better outcome.

Outcome measures

Measure

Iovera n=22 Participants The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.

FAOS - PAIN

21.7 score on a scale Standard Error 4.3

SECONDARY outcome

Timeframe: change between baseline/screening and 24-weeks following treatment

Population: Twenty two eligible participants completed 24-weeks follow-up treatment

The Numeric Rating Scale (NRS) is a numeric scale to rates the pain from 0 (no pain) to 10 (worst pain).

Outcome measures

Measure

Iovera n=22 Participants The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.

NRS Pain Over Prior 7 Days

-2.8 score on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: change between baseline/screening and 12-weeks following treatment

Population: Twenty seven eligible participants completed 12-weeks follow-up treatment

The Numeric Rating Scale (NRS) is a numeric scale to rates the pain from 0 (no pain) to 10 (worst pain).

Outcome measures

Measure

Iovera n=27 Participants The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.

NRS Pain Over Prior 7 Days

-2.6 score on a scale Standard Error 0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: change between baseline/screening and 6-weeks following treatment

Population: Thirty five eligible participants completed 6-weeks follow-up treatment

The 40-meter walk test is one of the three OARSI (Osteoarthritis Research Society International) recommended minimal core set of performance-based outcome measures in OA research and clinical practice.The 40m FPWT will take approximately 2 minutes for each subject to complete.

Outcome measures

Measure

Iovera n=35 Participants The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.

Change in 40m Fast Paced Walking Test (40m FPWT) Time Between Baseline/Screening and 6-weeks Following Treatment

-0.1 seconds Standard Error 2.3

OTHER_PRE_SPECIFIED outcome

Timeframe: change between baseline/screening and 12-weeks following treatment

Population: Twenty seven eligible participants completed 12-weeks follow-up treatment

The 40-meter walk test is one of the three OARSI (Osteoarthritis Research Society International) recommended minimal core set of performance-based outcome measures in OA research and clinical practice.The 40m FPWT will take approximately 2 minutes for each subject to complete.

Outcome measures

Measure

Iovera n=27 Participants The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.

Change in 40m Fast Paced Walking Test (40m FPWT) Time Between Baseline/Screening and 12-weeks Following Treatment

-1.2 seconds Standard Error 2.2

OTHER_PRE_SPECIFIED outcome

Timeframe: change between baseline/screening and 24-weeks following treatment

Population: Twenty two eligible participants completed 24-weeks follow-up treatment

The 40-meter walk test is one of the three OARSI (Osteoarthritis Research Society International) recommended minimal core set of performance-based outcome measures in OA research and clinical practice.The 40m FPWT will take approximately 2 minutes for each subject to complete.

Outcome measures

Measure

Iovera n=22 Participants The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.

Change in 40m Fast Paced Walking Test (40m FPWT) Time Between Baseline/Screening and 24-weeks Following Treatment

-1.8 seconds Standard Error 2.6

Adverse Events

Iovera

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Iovera n=40 participants at risk The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue. iovera: The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.
Musculoskeletal and connective tissue disorders arthralgia	35.0% 14/40 • Number of events 14 • All participants were followed for up to 24-weeks post cryoneurolysis treatment. Demographic and clinical characteristics for all participants were captured at baseline, 3, 6, 9, 12, 18 and 24-weeks follow-up. Over the 24-week follow-up period following cryoneurolysis treatment, 19 participants reported a total of 42 adverse events. Of these, 2 were deemed to be unrelated to the intervention, 4 unlikely related, 18 possibly related, 14 probably related and 5 definitely related. The most frequently reported adverse events were index ankle arthralgia and paraesthesia. There were no serious adverse events.
Vascular disorders Bruising	5.0% 2/40 • Number of events 2 • All participants were followed for up to 24-weeks post cryoneurolysis treatment. Demographic and clinical characteristics for all participants were captured at baseline, 3, 6, 9, 12, 18 and 24-weeks follow-up. Over the 24-week follow-up period following cryoneurolysis treatment, 19 participants reported a total of 42 adverse events. Of these, 2 were deemed to be unrelated to the intervention, 4 unlikely related, 18 possibly related, 14 probably related and 5 definitely related. The most frequently reported adverse events were index ankle arthralgia and paraesthesia. There were no serious adverse events.
Skin and subcutaneous tissue disorders Bullous Dermatitis	2.5% 1/40 • Number of events 1 • All participants were followed for up to 24-weeks post cryoneurolysis treatment. Demographic and clinical characteristics for all participants were captured at baseline, 3, 6, 9, 12, 18 and 24-weeks follow-up. Over the 24-week follow-up period following cryoneurolysis treatment, 19 participants reported a total of 42 adverse events. Of these, 2 were deemed to be unrelated to the intervention, 4 unlikely related, 18 possibly related, 14 probably related and 5 definitely related. The most frequently reported adverse events were index ankle arthralgia and paraesthesia. There were no serious adverse events.
General disorders fall	5.0% 2/40 • Number of events 2 • All participants were followed for up to 24-weeks post cryoneurolysis treatment. Demographic and clinical characteristics for all participants were captured at baseline, 3, 6, 9, 12, 18 and 24-weeks follow-up. Over the 24-week follow-up period following cryoneurolysis treatment, 19 participants reported a total of 42 adverse events. Of these, 2 were deemed to be unrelated to the intervention, 4 unlikely related, 18 possibly related, 14 probably related and 5 definitely related. The most frequently reported adverse events were index ankle arthralgia and paraesthesia. There were no serious adverse events.
Blood and lymphatic system disorders localized edema	12.5% 5/40 • Number of events 5 • All participants were followed for up to 24-weeks post cryoneurolysis treatment. Demographic and clinical characteristics for all participants were captured at baseline, 3, 6, 9, 12, 18 and 24-weeks follow-up. Over the 24-week follow-up period following cryoneurolysis treatment, 19 participants reported a total of 42 adverse events. Of these, 2 were deemed to be unrelated to the intervention, 4 unlikely related, 18 possibly related, 14 probably related and 5 definitely related. The most frequently reported adverse events were index ankle arthralgia and paraesthesia. There were no serious adverse events.
Musculoskeletal and connective tissue disorders muscle cramp	7.5% 3/40 • Number of events 3 • All participants were followed for up to 24-weeks post cryoneurolysis treatment. Demographic and clinical characteristics for all participants were captured at baseline, 3, 6, 9, 12, 18 and 24-weeks follow-up. Over the 24-week follow-up period following cryoneurolysis treatment, 19 participants reported a total of 42 adverse events. Of these, 2 were deemed to be unrelated to the intervention, 4 unlikely related, 18 possibly related, 14 probably related and 5 definitely related. The most frequently reported adverse events were index ankle arthralgia and paraesthesia. There were no serious adverse events.
Musculoskeletal and connective tissue disorders pain ( 1st web space)	2.5% 1/40 • Number of events 1 • All participants were followed for up to 24-weeks post cryoneurolysis treatment. Demographic and clinical characteristics for all participants were captured at baseline, 3, 6, 9, 12, 18 and 24-weeks follow-up. Over the 24-week follow-up period following cryoneurolysis treatment, 19 participants reported a total of 42 adverse events. Of these, 2 were deemed to be unrelated to the intervention, 4 unlikely related, 18 possibly related, 14 probably related and 5 definitely related. The most frequently reported adverse events were index ankle arthralgia and paraesthesia. There were no serious adverse events.
Nervous system disorders paraesthesia	27.5% 11/40 • Number of events 11 • All participants were followed for up to 24-weeks post cryoneurolysis treatment. Demographic and clinical characteristics for all participants were captured at baseline, 3, 6, 9, 12, 18 and 24-weeks follow-up. Over the 24-week follow-up period following cryoneurolysis treatment, 19 participants reported a total of 42 adverse events. Of these, 2 were deemed to be unrelated to the intervention, 4 unlikely related, 18 possibly related, 14 probably related and 5 definitely related. The most frequently reported adverse events were index ankle arthralgia and paraesthesia. There were no serious adverse events.
Immune system disorders pruritus	2.5% 1/40 • Number of events 1 • All participants were followed for up to 24-weeks post cryoneurolysis treatment. Demographic and clinical characteristics for all participants were captured at baseline, 3, 6, 9, 12, 18 and 24-weeks follow-up. Over the 24-week follow-up period following cryoneurolysis treatment, 19 participants reported a total of 42 adverse events. Of these, 2 were deemed to be unrelated to the intervention, 4 unlikely related, 18 possibly related, 14 probably related and 5 definitely related. The most frequently reported adverse events were index ankle arthralgia and paraesthesia. There were no serious adverse events.
Skin and subcutaneous tissue disorders skin disorder - other (lump)	5.0% 2/40 • Number of events 2 • All participants were followed for up to 24-weeks post cryoneurolysis treatment. Demographic and clinical characteristics for all participants were captured at baseline, 3, 6, 9, 12, 18 and 24-weeks follow-up. Over the 24-week follow-up period following cryoneurolysis treatment, 19 participants reported a total of 42 adverse events. Of these, 2 were deemed to be unrelated to the intervention, 4 unlikely related, 18 possibly related, 14 probably related and 5 definitely related. The most frequently reported adverse events were index ankle arthralgia and paraesthesia. There were no serious adverse events.

Additional Information

Neil Segal, MD

University of Kansas Medical Center

Phone: 9135740961

Email: segal-research@kumc.edu

Results disclosure agreements

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