Painful Total Knee Replacement (TKA) and I-one Therapy

NCT06330454 | Recruiting

• 1 other identifier: 483/2020/Disp/AOUFe
• Study Type: observational
• Target: 237
• Locations: 1 country
• Sites: 7

Brief Summary

Arthroplasty operations are very frequent and their number is constantly increasing. The success of prosthetic surgery is linked to surgical factors (prosthesis type, prosthesis design, prosthesis material, surgical hand) and 'biological' factors (inflammation, pain, oedema, impingement). It is well known that important functional limitations may result mainly from an overreaction involving the peri-articular tissues. This is particularly true after total knee arthroplasty (TKA) surgery, during which a large part of the bone tissue and part of the peri-articular tissues (joint capsule, ligaments, synovium) are dislodged or removed. In the days following arthroplasty operations, the presence of a strong local inflammatory component is associated with pain and functional limitation, which usually resolves within a few months; however, it can sometimes take longer, and sometimes result in a chronic, albeit modest, inflammatory condition that lasts for years. There is still a percentage of 11-25% of patients who remain not completely satisfied with the result achieved with prosthetic surgery . Baker et al. state that 19.8% of patients experience pain one year after arthroplasty . Beswick et al. report that many patients (10-34%) continue to experience significant pain and functional limitation after arthroplasty even years later.

Conditions

Knee Pain Swelling

Outcome Measures

Primary Outcomes (1)

• Evaluate pain resolution after treatment with I-ONE® therapy in patients with painful TKA at least 1 month after surgery.

  Visual analogue scales (VAS, 0 is the minimum and 10 is maximum values) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid classification of symptom severity and disease control.

  baseline, 30 days, 60 days, 180 days, 1 year, 2 years

Secondary Outcomes (2)

• reduced NSAID intake

  baseline, 30 days, 60 days, 180 days, 1 year, 2 years

• improved recovery of joint function

  baseline, 30 days, 60 days, 180 days, 1 year, 2 years

Study Arms (1)

Painfull TKA

Pulsed electromagnetic field therapy

Device: I-ONE

Interventions

I-ONE DEVICE

Pulsed Electromagnetic fields joint therapy

Painfull TKA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

outpatients, orthopaedic clinic

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (7)

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 Officials

• Leo Massari, MD

  Azienda Ospedaliera-Universitaria Arcispedale S. Anna di Ferrara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leo Massari, MD

CONTACT

+390532239797; msl@unife.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: October 22, 2020
• Primary Completion: October 21, 2025
• Study Completion: October 21, 2025
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

IT (7)