I-ONE therapy for pain relief after total knee replacement
Official title: Multicenter Prospective Observational Study in Patients With Painful Total Knee Replacement and I-one Therapy
Run by University Hospital of Ferrara · NCT06330454 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if I-ONE therapy can help reduce pain and swelling in patients who are recovering from total knee replacement surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 237 (estimated) |
| Sponsor | University Hospital of Ferrara Academic / other |
| Locations | 7 sites (Bologna, BO and 6 other locations) |
| Trial ID | NCT06330454 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals who have undergone total knee replacement surgery and are experiencing moderate to severe pain without any signs of infection.
✕Probably not a fit
Patients with pain due to mechanical issues, previous knee infections, or systemic inflammatory diseases may not benefit from this therapy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the effectiveness of I-ONE therapy, a biophysical stimulation treatment, in reducing pain and inflammation in patients who have undergone total knee arthroplasty (TKA). It focuses on patients experiencing significant knee pain and swelling between 30 to 180 days post-surgery. The study aims to evaluate how I-ONE therapy can modulate inflammatory responses and improve functional recovery by targeting pro-inflammatory cytokines in the synovial fluid. By analyzing the relationship between inflammation and recovery, the study seeks to provide insights into new therapeutic strategies for post-operative care.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce chronic pain and improve functional recovery for patients after knee replacement surgery.
How similar studies have gone: While the specific application of I-ONE therapy is novel, similar biophysical stimulation approaches have shown promise in managing post-surgical inflammation and pain.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * informed consent * painful total knee replacement at least 30 ± 3 days post-op up to a maximum of 180 ± 3 days post-op * VAS ≥ 5 * absence of infection Exclusion Criteria: * pain caused by mechanical problems (misalignment, mobilisation, etc.), * the presence of hip prostheses, * previous knee infections, * rheumatoid arthritis * autoimmune diseases * systemic diseases * tumours * major axial deviations * obesity (BMI \> 30 kg/m2).
Where it's running
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IRCCS Istituto Ortopedico Rizzoli
Bologna, Bo, Italy Recruiting -
Poliambulanza Brescia
Brescia, Bs, Italy Recruiting -
Policlinico San Matteo Pavia
Pavia, Pv, Italy Recruiting -
Ospedale Mauriziano Torino
Torino, To, Italy Recruiting -
Ospedale Sacro Cuore Don Calabria Negrar Verona
Negrar, Vr, Italy Recruiting -
Policlinico di Bari
Bari, Italy Recruiting
Show 1 more location
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Ospedale Santo Spirito in Sassia/Ospedale San Filippo Neri Roma
Roma, Italy Recruiting
Study contacts
- Principal investigator: Leo Massari, MD — Azienda Ospedaliera-Universitaria Arcispedale S. Anna di Ferrara
- Study coordinator: Leo Massari, MD
- Email: msl@unife.it
- Phone: +390532239797
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.