Osteo Arthritis KneeNCT03818022
Pain Control With Pre-operative Cryoneurolysis Following TKA
A study testing Cryoneurolysis (Iovera) in people with Osteo Arthritis Knee, run by Fondren Orthopedic Group L.L.P. at 1 site in United States.
Trial summary
The purpose of this study is to assess the potential benefit of preoperative cryoneurolysis in postoperative pain management of total knee arthroplasty patients over current pain management protocol. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Cryoneurolysis (Iovera)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any patient scheduled for primary total knee arthroplasty(TKA)
Who cannot join
- Bilateral TKA (patients routinely receive spinal anesthesia)
- Minors
- Patients reporting a history of Raynaud's disease
- Patients with an open and/or infected wound on surgical knee
- Patients who are taking opioids during the pre-operative period due to knee pain
- Patients who cannot return for the cryoneurolysis treatment 7 days prior to surgery or post-operative clinical visits
Show all 9Show fewer
- Patients whose insurance would deny payment for the cryoneurolysis treatment
- Pregnant patients
- Patients unable to speak and read English
Trial locations and contacts
1 site in 1 country.
United States1 site
Fondren Orthopedic Group, L.L.P.
Houston, Texas, 77030
About this study
Official title: Effectiveness of Preoperative Cryoneurolysis (Iovera) for Postoperative Pain Control in Total Knee Arthroplasty
The purpose of this study is to assess the potential benefit of preoperative cryoneurolysis in postoperative pain management of total knee arthroplasty patients over current pain management protocol.
Read the detailed description
Cryoneurolysis, is a novel technique that can yield temporary blockade of superficial sensory nerves, generating immediate and meaningful relief of pain.The technique generates an axonotmesis of the targeted peripheral nerves by percutaneously applying low temperatures (-100 °C to -20 °C). Wallerian degeneration is produced whereby the axons and the myelin sheath are damaged but the endoneurium, perineurium and epineurium remain intact. Therefore, permanent damage to the nerve is avoided as it retains its regenerative properties. With regards to the knee, the infrapatellar branch of the saphenous nerve (IPBSN), a sensory branch serving both the inferior and anterior portion of the knee capsule and the antero-medial skin of the knee is the prime target for the procedure.
Your participation in this study requires that you allow the radiology department of Texas Orthopedic Hospital to administer Cryoneurolysis using the Iovera device with the functional smart tip approximately 1 week prior to total knee arthroplasty surgery. A highly localized cold zone is created via the Joule-Thompson effect as nitrous oxide enters the needles. Nothing is injected into the body and the nitrous oxide gas is vented safely out of the handpiece. Cryoneurolysis is administered following local anesthesia.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Cryoneurolysis (Iovera)
- Keywords
- knee, joint replacement, total knee, cryoneurolysis, Iovera, TKA, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoneurolysis (Iovera)Procedure or surgery
Cryoneurolysis performed by radiology department 1 week prior to total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients receiving Cryoneurolysis (Iovera) prior to total knee arthroplasty Receives: Procedure: Cryoneurolysis (Iovera) |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Veterans Rand-12 (VR-12)
VR-12 is a 12 item questionnaire that measures health related quality of life. Scores range from 0 to 100 with 50 being an average score and higher scores representing better health related quality of life.
Measured: up to 3 months
Knee Injury and Osteoarthritis Outcomes Survey (KOOS Jr)
KOOS Jr. is a short questionnaire that evaluates knee pain and function. Scores range from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
Measured: up to 3 months
Secondary outcomes (4)
Number of subject with an adverse effect from treatment
Any complication during treatment will be recorded.
Measured: up to 3 months
Range of motion
During clinical office visits, your ability to bend and straighten your knee will be recorded.
Measured: up to 3 months
Knee function
During clinical office visits, your ability to perform daily activities with regards to your knee will be recorded.
Measured: up to 3 months
Knee swelling
The amount of swelling in your knee will be recorded.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 Feb 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Lost interest in study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondren Orthopedic Group L.L.P.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818022
- Sponsor's protocol ID
- TOH180
- Status last verified
- Feb 2024
- First submitted
- 9 Jan 2019
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Preoperative Cryoneurolysis (Iovera) for Postoperative Pain Control in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03818022
- Acronym / sponsor ID
- TOH180
- Conditions
- Osteo Arthritis Knee
- Keywords
- knee, joint replacement, total knee, cryoneurolysis, Iovera, TKA, pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lost interest in study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondren Orthopedic Group L.L.P.University, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the potential benefit of preoperative cryoneurolysis in postoperative pain management of total knee arthroplasty patients over current pain management protocol.
Detailed description
Cryoneurolysis, is a novel technique that can yield temporary blockade of superficial sensory nerves, generating immediate and meaningful relief of pain.The technique generates an axonotmesis of the targeted peripheral nerves by percutaneously applying low temperatures (-100 °C to -20 °C). Wallerian degeneration is produced whereby the axons and the myelin sheath are damaged but the endoneurium, perineurium and epineurium remain intact. Therefore, permanent damage to the nerve is avoided as it retains its regenerative properties. With regards to the knee, the infrapatellar branch of the saphenous nerve (IPBSN), a sensory branch serving both the inferior and anterior portion of the knee capsule and the antero-medial skin of the knee is the prime target for the procedure.
Your participation in this study requires that you allow the radiology department of Texas Orthopedic Hospital to administer Cryoneurolysis using the Iovera device with the functional smart tip approximately 1 week prior to total knee arthroplasty surgery. A highly localized cold zone is created via the Joule-Thompson effect as nitrous oxide enters the needles. Nothing is injected into the body and the nitrous oxide gas is vented safely out of the handpiece. Cryoneurolysis is administered following local anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Cryoneurolysis (Iovera)Patients receiving Cryoneurolysis (Iovera) prior to total knee arthroplasty |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any patient scheduled for primary total knee arthroplasty(TKA)
Key exclusion criteria (9 listed)
- Bilateral TKA (patients routinely receive spinal anesthesia)
- Minors
- Patients reporting a history of Raynaud's disease
- Patients with an open and/or infected wound on surgical knee
- Patients who are taking opioids during the pre-operative period due to knee pain
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 |
|---|---|---|
| Cryoneurolysis (Iovera)Cryoneurolysis performed by radiology department 1 week prior to total knee arthroplasty | Procedure or surgery | Experimental |
Primary outcome
Veterans Rand-12 (VR-12)
Time frame: up to 3 months
VR-12 is a 12 item questionnaire that measures health related quality of life. Scores range from 0 to 100 with 50 being an average score and higher scores representing better health related quality of life.
Knee Injury and Osteoarthritis Outcomes Survey (KOOS Jr)
Time frame: up to 3 months
KOOS Jr. is a short questionnaire that evaluates knee pain and function. Scores range from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
4 secondary outcomes
Number of subject with an adverse effect from treatment
Time frame: up to 3 months
Range of motion
Time frame: up to 3 months
Knee function
Time frame: up to 3 months
Knee swelling
Time frame: up to 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoneurolysis (Iovera) in people with Osteo Arthritis Knee, run by Fondren Orthopedic Group L.L.P. 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 1 inclusion and 9 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: withdrawn, as of the sponsor's last update on 23 Feb 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Veterans Rand-12 (VR-12) (time frame: up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.