Multicenter Prospective Observational Study in Patients With Painful Total Knee Replacement and I-one Therapy

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Policlinico di Bari
RECRUITING
Bari
IRCCS Istituto Ortopedico Rizzoli
RECRUITING
Bologna
Poliambulanza Brescia
RECRUITING
Brescia
Ospedale Sacro Cuore Don Calabria Negrar Verona
RECRUITING
Negrar
Policlinico San Matteo Pavia
RECRUITING
Pavia
Ospedale Santo Spirito in Sassia/Ospedale San Filippo Neri Roma
RECRUITING
Roma
Ospedale Mauriziano Torino
RECRUITING
Torino
Contact Information
Primary
Leo Massari, MD
msl@unife.it
+390532239797
Time Frame
Start Date: 2020-10-22
Estimated Completion Date: 2025-10-21
Participants
Target number of participants: 237
Treatments
Painfull TKA
Pulsed electromagnetic field therapy
Related Therapeutic Areas
Sponsors
Leads: University Hospital of Ferrara

This content was sourced from clinicaltrials.gov