I-ONE therapy for pain relief after total knee replacement
Multicenter Prospective Observational Study in Patients With Painful Total Knee Replacement and I-one Therapy
University Hospital of Ferrara · NCT06330454
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 |
|---|---|
| Enrollment | 237 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital of Ferrara (other) |
| Locations | 7 sites (Bologna, BO and 6 other locations) |
| Trial ID | NCT06330454 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with pain due to mechanical issues, previous knee infections, or systemic inflammatory diseases may not benefit from this therapy.
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 performed: While the specific application of I-ONE therapy is novel, similar biophysical stimulation approaches have shown promise in managing post-surgical inflammation and pain.
Eligibility criteria
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 this trial is running
Bologna, BO and 6 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Knee Pain Swelling