Ankle OsteoarthritisNCT03567187
Cryoneurolysis for Improvements in Pain, ADL and QOL in Patients With Ankle Osteoarthritis
A study testing iovera in people with Ankle Osteoarthritis, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This will be an open-label trial to describe the effects of cryoneurolysis with iovera° on symptom relief in patients with painful Kellgren-Lawrence (KL) grade 2-4 ankle osteoarthritis (OA). The Foot and Ankle Outcome Score (FAOS) subscales will be used to assess outcomes at 6, 12 and 24 weeks after treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Osteoarthritis
- What is being tested?
- iovera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2018to 28 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in an institutional review board-approved informed consent process, culminating in providing written consent.
- Willingness and ability to comply with the study procedures, visit schedules and ability to follow verbal and written instructions.
- Male or female over 18 years of age.
- Currently Kellgren-Lawrence (KL) Grade 2, 3 or 4 in the ankle based on X-ray (weight-bearing mortise views with 20° internal rotation) or weight-bearing CT scan of the ankles.
- Limited by unilateral ankle pain, rated on a Numerical Rating Scale for pain severity as ≥5 on most days over the last month.
- Foot and ankle outcome score (FAOS) of < 75 in at least 1 category.
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- Body mass index (BMI) ≤ 50 kg/m2
- Ambulatory
- Willingness to abstain from the use of protocol-restricted medications during the study and also willing to abstain from use of analgesics other than acetaminophen 1 week prior to beginning of the study.
- Has undergone at least one prior conservative osteoarthritis treatment (e.g. physical therapy, analgesics).
Who cannot join
- Baseline knee, hip, spine or other limitations that affect walking ability to a greater extent than the ankle.
- Cryoglobulinemia, paroxysmal cold hemoglobinuria, Raynaud's disease, cold urticaria.
- Clinical signs or symptoms of active or recurrent infection in the index ankle joint or overlying skin.
- Intra-articular, intravenous or intramuscular corticosteroid (investigational or marketed) within 3 months of screening
- Oral corticosteroids (investigational or marketed) within 2 weeks of screening (unless on a chronic stable dose for ≥3 months prior to enrollment).
- Women who are pregnant (due to potential for the change in body mass and distribution to alter ankle symptoms over the period of follow-up).
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- Any condition other than OA of the ankle joint which, in the opinion of the investigators, affects their ability to ambulate to a sufficient degree to interfere with the assessment of the safety and treatment effects of the study injection.
- Arthroscopy or open surgery of the ankle joint within 6 months of screening.
- Planned/anticipated surgery of the index ankle joint during the 6-month study period.
- Any clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening which, in the opinion of the investigator, could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study injection.
- Skin breakdown at the ankle joint where the injection is planned to take place.
- Participated in any investigational drug or device trial within 30 days prior to screening or concurrent participation in another research study that could complicate interpretation of the findings of either study.
- Current consumption of more than 14 alcoholic drinks per week.
- Patients with diffuse pain conditions (Complex pain - diffuse or confounding pain, fibromyalgia, etc.).
- Known altered nerve anatomy or physiology (e.g. neuropathy) at the target, such as due to a congenital, traumatic or surgical cause.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Cryoneurolysis for Improvements in Pain, Activities of Daily Living and Quality of Life in Patients With Ankle Osteoarthritis
This will be an open-label trial to describe the effects of cryoneurolysis with iovera° on symptom relief in patients with painful Kellgren-Lawrence (KL) grade 2-4 ankle osteoarthritis (OA). The Foot and Ankle Outcome Score (FAOS) subscales will be used to assess outcomes at 6, 12 and 24 weeks after treatment.
Read the detailed description
The aim of this study is to assess clinically significant long-term symptomatic relief with cryoneurolysis in people with unilateral ankle osteoarthritis (OA). The investigators will treat 1) the Superficial Fibular Nerve (SFN), Sural Nerve (SN) and Saphenous Nerve and/or 2) the Deep Fibular Nerve (DFN) with cryoneurolysis using the iovera° device. The primary study endpoint, clinically significant improvement in pain 12 weeks after each treatment, will be assessed using the FAOS pain subscale. If a participant is a non-responder (<20% improvement in pain within the 12 weeks following baseline), then the other treatment will be offered (e.g. if start with superficial group, then offer the DFN).
The secondary outcomes will be improvement in quality of life (FAOS-QoL), activities of daily living (FAOS-ADL) and Numerical Rating Scale (NRS) for pain.
The tertiary outcome will be improvement in physical performance measures (40m fast-paced walking test, standing balance test).
- Conditions
- Ankle Osteoarthritis
- Being tested
- iovera
- Keywords
- Cryoneurolysis, iovera, Superficial nerves treatment, Deep Fibular Nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ioveraDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Iovera | Experimental | 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. Receives: Device: iovera |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAOS - PAIN
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.
Measured: Change between baseline/screening and 12-weeks following treatment
Secondary outcomes (11)
NRS Pain Over Prior 7 Days
The Numeric Rating Scale (NRS) is a numeric scale to rates the pain from 0 (no pain) to 10 (worst pain).
Measured: change between baseline/screening and 6-weeks following treatment
FAOS - ADL(Activity of Daily Living)
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.
Measured: change between baseline/screening and 12-weeks following treatment
FAOS - ADL(Activity of Daily Living)
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.
Measured: change between baseline/screening and 6-weeks following treatment
FAOS - ADL(Activity of Daily Living)
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.
Measured: change between baseline/screening and 24-weeks following treatment
FAOS-QoL(Quality of Life)
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.
Measured: change between baseline/screening and 12-weeks following treatment
FAOS-QoL(Quality of Life)
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.
Measured: change between baseline/screening and 6-weeks following treatment
FAOS-QoL(Quality of Life)
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.
Measured: change between baseline/screening and 24-weeks following treatment
FAOS - PAIN
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.
Measured: change between baseline/screening and 6-weeks following treatment
FAOS - PAIN
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.
Measured: change between baseline/screening and 24-weeks following treatment
NRS Pain Over Prior 7 Days
The Numeric Rating Scale (NRS) is a numeric scale to rates the pain from 0 (no pain) to 10 (worst pain).
Measured: change between baseline/screening and 24-weeks following treatment
NRS Pain Over Prior 7 Days
The Numeric Rating Scale (NRS) is a numeric scale to rates the pain from 0 (no pain) to 10 (worst pain).
Measured: change between baseline/screening and 12-weeks following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start3 Jul 2018
- Primary completion28 Jan 2021
- Study completion28 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Ankle OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Segal, MD, MS, University of Kansas Medical Center
- Investigators
- Neil A Segal, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567187
- Sponsor's protocol ID
- STUDY00142298
- Status last verified
- May 2024
- First submitted
- 12 Jun 2018
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ward ST, Williams PL, Purkayastha S. Intra-articular corticosteroid injections in the foot and ankle: a prospective 1-year follow-up investigation. J Foot Ankle Surg. 2008 Mar-Apr;47(2):138-44. doi: 10.1053/j.jfas.2007.12.007.
PubMed 18312921Valderrabano V, Horisberger M, Russell I, Dougall H, Hintermann B. Etiology of ankle osteoarthritis. Clin Orthop Relat Res. 2009 Jul;467(7):1800-6. doi: 10.1007/s11999-008-0543-6. Epub 2008 Oct 2.
PubMed 18830791Repetto I, Biti B, Cerruti P, Trentini R, Felli L. Conservative Treatment of Ankle Osteoarthritis: Can Platelet-Rich Plasma Effectively Postpone Surgery? J Foot Ankle Surg. 2017 Mar-Apr;56(2):362-365. doi: 10.1053/j.jfas.2016.11.015.
PubMed 28231968Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60.
PubMed 16880882Evans PJ, Lloyd JW, Green CJ. Cryoanalgesia: the response to alterations in freeze cycle and temperature. Br J Anaesth. 1981 Nov;53(11):1121-7. doi: 10.1093/bja/53.11.1121.
PubMed 7326160Golightly YM, Devellis RF, Nelson AE, Hannan MT, Lohmander LS, Renner JB, Jordan JM. Psychometric properties of the foot and ankle outcome score in a community-based study of adults with and without osteoarthritis. Arthritis Care Res (Hoboken). 2014 Mar;66(3):395-403. doi: 10.1002/acr.22162.
PubMed 24023029Mani SB, Do H, Vulcano E, Hogan MV, Lyman S, Deland JT, Ellis SJ. Evaluation of the foot and ankle outcome score in patients with osteoarthritis of the ankle. Bone Joint J. 2015 May;97-B(5):662-7. doi: 10.1302/0301-620X.97B5.33940.
PubMed 25922461Holzer N, Salvo D, Marijnissen AC, Vincken KL, Ahmad AC, Serra E, Hoffmeyer P, Stern R, Lubbeke A, Assal M. Radiographic evaluation of posttraumatic osteoarthritis of the ankle: the Kellgren-Lawrence scale is reliable and correlates with clinical symptoms. Osteoarthritis Cartilage. 2015 Mar;23(3):363-9. doi: 10.1016/j.joca.2014.11.010. Epub 2014 Nov 15.
PubMed 25463444Roos EM, Brandsson S, Karlsson J. Validation of the foot and ankle outcome score for ankle ligament reconstruction. Foot Ankle Int. 2001 Oct;22(10):788-94. doi: 10.1177/107110070102201004.
PubMed 11642530Hunt KJ, Hurwit D. Use of patient-reported outcome measures in foot and ankle research. J Bone Joint Surg Am. 2013 Aug 21;95(16):e118(1-9). doi: 10.2106/JBJS.L.01476.
PubMed 23965711Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.
PubMed 23680877McDaniel G, Renner JB, Sloane R, Kraus VB. Association of knee and ankle osteoarthritis with physical performance. Osteoarthritis Cartilage. 2011 Jun;19(6):634-8. doi: 10.1016/j.joca.2011.01.016. Epub 2011 Feb 19.
PubMed 21310252Radnovich R, Scott D, Patel AT, Olson R, Dasa V, Segal N, Lane NE, Shrock K, Naranjo J, Darr K, Surowitz R, Choo J, Valadie A, Harrell R, Wei N, Metyas S. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1247-1256. doi: 10.1016/j.joca.2017.03.006. Epub 2017 Mar 20.
PubMed 28336454
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoneurolysis for Improvements in Pain, Activities of Daily Living and Quality of Life in Patients With Ankle Osteoarthritis
- ClinicalTrials.gov ID
- NCT03567187
- Acronym / sponsor ID
- STUDY00142298
- Conditions
- Ankle Osteoarthritis
- Keywords
- Cryoneurolysis, iovera, Superficial nerves treatment, Deep Fibular Nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 28 Jan 2021 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 25 Jun 2018 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be an open-label trial to describe the effects of cryoneurolysis with iovera° on symptom relief in patients with painful Kellgren-Lawrence (KL) grade 2-4 ankle osteoarthritis (OA). The Foot and Ankle Outcome Score (FAOS) subscales will be used to assess outcomes at 6, 12 and 24 weeks after treatment.
Detailed description
The aim of this study is to assess clinically significant long-term symptomatic relief with cryoneurolysis in people with unilateral ankle osteoarthritis (OA). The investigators will treat 1) the Superficial Fibular Nerve (SFN), Sural Nerve (SN) and Saphenous Nerve and/or 2) the Deep Fibular Nerve (DFN) with cryoneurolysis using the iovera° device. The primary study endpoint, clinically significant improvement in pain 12 weeks after each treatment, will be assessed using the FAOS pain subscale. If a participant is a non-responder (<20% improvement in pain within the 12 weeks following baseline), then the other treatment will be offered (e.g. if start with superficial group, then offer the DFN).
The secondary outcomes will be improvement in quality of life (FAOS-QoL), activities of daily living (FAOS-ADL) and Numerical Rating Scale (NRS) for pain.
The tertiary outcome will be improvement in physical performance measures (40m fast-paced walking test, standing balance test).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iovera | Experimental | Device: ioveraThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participation in an institutional review board-approved informed consent process, culminating in providing written consent.
- Willingness and ability to comply with the study procedures, visit schedules and ability to follow verbal and written instructions.
- Male or female over 18 years of age.
- Currently Kellgren-Lawrence (KL) Grade 2, 3 or 4 in the ankle based on X-ray (weight-bearing mortise views with 20° internal rotation) or weight-bearing CT scan of the ankles.
- Limited by unilateral ankle pain, rated on a Numerical Rating Scale for pain severity as ≥5 on most days over the last month.
Key exclusion criteria (15 listed)
- Baseline knee, hip, spine or other limitations that affect walking ability to a greater extent than the ankle.
- Cryoglobulinemia, paroxysmal cold hemoglobinuria, Raynaud's disease, cold urticaria.
- Clinical signs or symptoms of active or recurrent infection in the index ankle joint or overlying skin.
- Intra-articular, intravenous or intramuscular corticosteroid (investigational or marketed) within 3 months of screening
- Oral corticosteroids (investigational or marketed) within 2 weeks of screening (unless on a chronic stable dose for ≥3 months prior to enrollment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ioveraThe 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. | Device | Iovera |
Primary outcome
FAOS - PAIN
Time frame: Change between baseline/screening and 12-weeks following 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.
11 secondary outcomes
NRS Pain Over Prior 7 Days
Time frame: change between baseline/screening and 6-weeks following treatment
FAOS - ADL(Activity of Daily Living)
Time frame: change between baseline/screening and 12-weeks following treatment
FAOS - ADL(Activity of Daily Living)
Time frame: change between baseline/screening and 6-weeks following treatment
FAOS - ADL(Activity of Daily Living)
Time frame: change between baseline/screening and 24-weeks following treatment
FAOS-QoL(Quality of Life)
Time frame: change between baseline/screening and 12-weeks following treatment
FAOS-QoL(Quality of Life)
Time frame: change between baseline/screening and 6-weeks following treatment
FAOS-QoL(Quality of Life)
Time frame: change between baseline/screening and 24-weeks following treatment
FAOS - PAIN
Time frame: change between baseline/screening and 6-weeks following treatment
FAOS - PAIN
Time frame: change between baseline/screening and 24-weeks following treatment
NRS Pain Over Prior 7 Days
Time frame: change between baseline/screening and 24-weeks following treatment
NRS Pain Over Prior 7 Days
Time frame: change between baseline/screening and 12-weeks following treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18312921Ward ST, Williams PL, Purkayastha S. Intra-articular corticosteroid injections in the foot and ankle: a prospective 1-year follow-up investigation. J Foot Ankle Surg. 2008 Mar-Apr;47(2):138-44. doi: 10.1053/j.jfas.2007.12.007.
- Background: PubMed 18830791Valderrabano V, Horisberger M, Russell I, Dougall H, Hintermann B. Etiology of ankle osteoarthritis. Clin Orthop Relat Res. 2009 Jul;467(7):1800-6. doi: 10.1007/s11999-008-0543-6. Epub 2008 Oct 2.
- Background: PubMed 28231968Repetto I, Biti B, Cerruti P, Trentini R, Felli L. Conservative Treatment of Ankle Osteoarthritis: Can Platelet-Rich Plasma Effectively Postpone Surgery? J Foot Ankle Surg. 2017 Mar-Apr;56(2):362-365. doi: 10.1053/j.jfas.2016.11.015.
- Background: PubMed 16880882Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60.
- Background: PubMed 7326160Evans PJ, Lloyd JW, Green CJ. Cryoanalgesia: the response to alterations in freeze cycle and temperature. Br J Anaesth. 1981 Nov;53(11):1121-7. doi: 10.1093/bja/53.11.1121.
- Background: PubMed 24023029Golightly YM, Devellis RF, Nelson AE, Hannan MT, Lohmander LS, Renner JB, Jordan JM. Psychometric properties of the foot and ankle outcome score in a community-based study of adults with and without osteoarthritis. Arthritis Care Res (Hoboken). 2014 Mar;66(3):395-403. doi: 10.1002/acr.22162.
- Background: PubMed 25922461Mani SB, Do H, Vulcano E, Hogan MV, Lyman S, Deland JT, Ellis SJ. Evaluation of the foot and ankle outcome score in patients with osteoarthritis of the ankle. Bone Joint J. 2015 May;97-B(5):662-7. doi: 10.1302/0301-620X.97B5.33940.
- Background: PubMed 25463444Holzer N, Salvo D, Marijnissen AC, Vincken KL, Ahmad AC, Serra E, Hoffmeyer P, Stern R, Lubbeke A, Assal M. Radiographic evaluation of posttraumatic osteoarthritis of the ankle: the Kellgren-Lawrence scale is reliable and correlates with clinical symptoms. Osteoarthritis Cartilage. 2015 Mar;23(3):363-9. doi: 10.1016/j.joca.2014.11.010. Epub 2014 Nov 15.
- Background: PubMed 11642530Roos EM, Brandsson S, Karlsson J. Validation of the foot and ankle outcome score for ankle ligament reconstruction. Foot Ankle Int. 2001 Oct;22(10):788-94. doi: 10.1177/107110070102201004.
- Background: PubMed 23965711Hunt KJ, Hurwit D. Use of patient-reported outcome measures in foot and ankle research. J Bone Joint Surg Am. 2013 Aug 21;95(16):e118(1-9). doi: 10.2106/JBJS.L.01476.
- Background: PubMed 23680877Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.
- Background: PubMed 21310252McDaniel G, Renner JB, Sloane R, Kraus VB. Association of knee and ankle osteoarthritis with physical performance. Osteoarthritis Cartilage. 2011 Jun;19(6):634-8. doi: 10.1016/j.joca.2011.01.016. Epub 2011 Feb 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil A Segal, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iovera in people with Ankle Osteoarthritis, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FAOS - PAIN (time frame: Change between baseline/screening and 12-weeks following treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03567187, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.