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New treatment option for Pain
Official title Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT07191067
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- 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.
You likely can't join if
- 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;
See the full eligibility criteria
- 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.
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Daphne, Alabama, United States
- Upland, California, United States
- Chapel Hill, North Carolina, United States
- Medford, Oregon, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Daphne, Alabama, United States; Upland, California, United States; Chapel Hill, North Carolina, United States; Medford, Oregon, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.