PainNOVABLOC-TKANCT07191067
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
A study testing Percutaneous radiofrequency electrical nerve stimulation and Non-therapeutic stimulation in people with Pain, run by Synaptrix, Inc. at 5 sites in United States.
Trial summary
Multi-center, randomized, blinded, sham-controlled study to determin the safety and efficacy of the NOVABLOC system on post-operative pain in patients undergoing TKA procedures. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Percutaneous radiofrequency electrical nerve stimulation and Non-therapeutic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Sep 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant females age ≥ 21 years of age;
- Has an underlying diagnosis of osteoarthritis indicated for a primary unilateral TKA according to established treatment guidelines;
- Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI);
- Able and willing to comply with all trial tests, procedures, assessments, and follow-up visits for up to 45 days.
- Able to read and understand instructions and information presented in English.
Who cannot join
- Chronic opioid use (average ≥ 30 oral morphine equivalents / day) ≤ thirty (30) days of the TKA procedure;
- Extended-release or long-acting opioid (e.g. buprenorphine, Morphine ER, etc.) use ≤ thirty (30) days of the TKA procedure;
- History of substance abuse or misuse;
- History of significant cardiac disease (e.g. ejection fraction ≤ 50%; coronary intervention ≤ six (6) months; significant valvular abnormalities);
- Prior radiofrequency ablation or cryotherapy for pain on the operative knee;
- Prior TKA on the operative knee;
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- BMI > 40;
- History of neurological, neuromuscular or neuropathic disease that would confound the study results, including chronic pain conditions;
- Have an active implanted biomedical device (such as cardiac pacemaker, insulin pump, pain stimulator, implantable cardioverter defibrillator) or cochlear [ear] stimulator);
- History of hip or knee dislocation or bone fractures on the operative leg;
- Sepsis or systemic infectious illness; local infection of skin or subcutaneous tissues where procedural access is required including thigh, hip or groin;
- Concomitant medical or psychiatric illness that could compromise evaluation or treatment, including anxiety (GAD-7 score >10) or depression (PHQ-9 score >15);
- Pregnant, actively planning a pregnancy or breast-feeding a child;
- Uncontrolled diabetes (A1C > 7.5%);
- History of bleeding disorder;
- Participating in another clinical trial/investigation within 45 days prior to signing informed consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of North Carolina
Chapel Hill, North Carolina, 27517
Alabama Orthopedic Sports Medicine & Baldwin County Surgery Center
Daphne, Alabama, 36526
Southern Oregon Orthopedics
Medford, Oregon, 97504
Virginia Mason Medical Center
Seattle, Washington, 98101
UBMD Orthopedics and Sports Medicine
Williamsville, New York, 14221
About this study
Official title: A Multi-Center Two-Arm, Randomized, Blinded, Sham-Controlled Trial to Determine the Safety and Efficacy of the NOVABLOC System on Postoperative Pain, Functional Recovery and Opioid Use in Patients Undergoing Primary Total Knee Arthroplasty
Multi-center, randomized, blinded, sham-controlled study to determin the safety and efficacy of the NOVABLOC system on post-operative pain in patients undergoing TKA procedures.
- Conditions
- Pain
- Being tested
- Percutaneous radiofrequency electrical nerve stimulation, Non-therapeutic stimulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous radiofrequency electrical nerve stimulationDevice
Percutaneous radiofrequency electrical nerve stimulation will be applied to the femoral and sciatic nerves prior to TKA.
Non-therapeutic stimulationDevice
Electrical square wave stimulation performed to mimic the duration of the active arm and mimic the procedure for blinding purposes.
| Study group | Role | What they receive |
|---|---|---|
| NOVABLOC Stimulation | Active comparator | Subjects will receive NOVABLOC stimulation prior to their TKA Receives: Device: Percutaneous radiofrequency electrical nerve stimulation |
| Sham Stimulation | Sham comparator | Subject will receive sham non-therapeutic stimulation Receives: Device: Non-therapeutic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worst Pain at Day 10
The worst pain felt by each subject at day 10 after the TKA procedure (as measured by question 3 on the BPI)
Measured: 10 days post-TKA
Secondary outcomes (1)
Total morphine equivalents used
Total morphine equivalents used cumulatively through Day 5
Measured: 5 days post-TKA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start30 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synaptrix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191067
- Sponsor's protocol ID
- 1-25-001
- Acronym
- NOVABLOC-TKA
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Two-Arm, Randomized, Blinded, Sham-Controlled Trial to Determine the Safety and Efficacy of the NOVABLOC System on Postoperative Pain, Functional Recovery and Opioid Use in Patients Undergoing Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07191067
- Acronym / sponsor ID
- NOVABLOC-TKA / 1-25-001
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Synaptrix, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 24 Sep 2025 (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.
Multi-center, randomized, blinded, sham-controlled study to determin the safety and efficacy of the NOVABLOC system on post-operative pain in patients undergoing TKA procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOVABLOC Stimulation | Active comparator | Device: Percutaneous radiofrequency electrical nerve stimulationSubjects will receive NOVABLOC stimulation prior to their TKA |
| Sham Stimulation | Sham comparator | Device: Non-therapeutic stimulationSubject will receive sham non-therapeutic stimulation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or non-pregnant females age ≥ 21 years of age;
- Has an underlying diagnosis of osteoarthritis indicated for a primary unilateral TKA according to established treatment guidelines;
- Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI);
- Able and willing to comply with all trial tests, procedures, assessments, and follow-up visits for up to 45 days.
- Able to read and understand instructions and information presented in English.
Key exclusion criteria (16 listed)
- Chronic opioid use (average ≥ 30 oral morphine equivalents / day) ≤ thirty (30) days of the TKA procedure;
- Extended-release or long-acting opioid (e.g. buprenorphine, Morphine ER, etc.) use ≤ thirty (30) days of the TKA procedure;
- History of substance abuse or misuse;
- History of significant cardiac disease (e.g. ejection fraction ≤ 50%; coronary intervention ≤ six (6) months; significant valvular abnormalities);
- Prior radiofrequency ablation or cryotherapy for pain on the operative knee;
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 |
|---|---|---|
| Percutaneous radiofrequency electrical nerve stimulationPercutaneous radiofrequency electrical nerve stimulation will be applied to the femoral and sciatic nerves prior to TKA. | Device | NOVABLOC Stimulation |
| Non-therapeutic stimulationElectrical square wave stimulation performed to mimic the duration of the active arm and mimic the procedure for blinding purposes. | Device | Sham Stimulation |
Primary outcome
Worst Pain at Day 10
Time frame: 10 days post-TKA
The worst pain felt by each subject at day 10 after the TKA procedure (as measured by question 3 on the BPI)
1 secondary outcome
Total morphine equivalents used
Time frame: 5 days post-TKA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous radiofrequency electrical nerve stimulation and Non-therapeutic stimulation in people with Pain, run by Synaptrix, Inc. at 5 sites 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 5 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Worst Pain at Day 10 (time frame: 10 days post-TKA). 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 26 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.