Condition category
Musculoskeletal Diseases
Date applied
15/02/2013
Date assigned
27/02/2013
Last edited
05/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paolo Adravanti

ORCID ID

Contact details

Piazza Maestri 5
Parma
43100
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v.01_2013

Study information

Scientific title

Evaluation of I-ONE therapy in patients undergoing total knee arthoplasty: a prospective randomised controlled group trial

Acronym

PITTKA

Study hypothesis

Total knee arthroplasty (TKA) is often associated with a severe local inflammatory reaction which, unless controlled, leads to persistent pain up to one year after surgery. Standard and accelerated rehabilitation protocols are currently being implemented after TKA, but no consensus exists regarding the long-term effects. Biophysical stimulation with pulsed electromagnetic fields (PEMFs) has been demonstrated to exert an anti-inflammatory effect, to promote early functional recovery and to maintain a positive long-term effect in patients undergoing joint arthroscopy.

Ethics approval

The IRB of the Clinic "Città di Parma" (italy) approved the protocol in January 2008.

Study design

Prospective randomised controlled group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please contact segreteria@paoloadravanti.com to request a patient information sheet

Condition

Knee osteoarthritis

Intervention

Patients who satisfy inclusion criteria, receiving a cemented postero-stabilized (PS) TKA with patella resurfacing, randomised in two groups:
1. Experimental group: standard rehabilitation protocol + I-ONE therapy, post-surgery (within one week), 4 hours/day for 60 days
2. Control group: standard rehabilitation protocol

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Pain, measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain) at baseline, 1, 2, 6 and 36 months.

Secondary outcome measures

1. Knee Society Score, involving a clinical evaluation, Knee Score (that assesses pain, range of motion, stability, contracture in bending, active extension deficit, alignment) and a functional one, Functional Score (that examines autonomy in walking, climbing stairs, use of stick or frame), both with values from 0 to 100.
2. Functional evaluation scale SF-36, that evaluates the patient with 36 questions, 10 of which one physical activity, 4 on role limitations due to physical health, 3 on role limitations correlated to emotional state, 2 on physical pain, 5 on perception of state of general health, 4 on vitality, 2 on social activities, 5 on mental health and 1 on change in state of health.
3. Joint swelling: A scale, with scores from 1 to 40, to quantify the presence of joint swelling evaluated by the operator on palpation by balloting the knee.
4. Monitoring of assumption of NSAIDs at all follow-ups

All outcomes assessed at 1, 2, and 6 months.

5. Pain and functional outcomes (modified from KSS) at 36 months

Overall trial start date

01/02/2008

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female patients aged between 60 and 85 years
2. Presenting with an advanced state of knee OA and scheduled for TKA, with varus or valgus deformity not exceeding 20° or 15°, respectively, and with a flexion contracture of less than 15°.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

From 1 to 33

Participant exclusion criteria

1. Previous surgery to the same knee
2. Omolateral hip prosthesis
3. Body Mass Index (BMI; Kg/m2) >30
4. Rheumatoid arthritis
5. Autoimmune diseases
6. Systemic diseases
7. Cancer and the use of steroids

Recruitment start date

01/02/2008

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Italy

Trial participating centre

Piazza Maestri 5
Parma
43100
Italy

Sponsor information

Organisation

IGEA S.p.A (Italy)

Sponsor details

Via Parmenide
10/A
Carpi
41012
Italy
s.setti@igeamedical.com

Sponsor type

Industry

Website

http://www.igeamedical.com

Funders

Funder type

Industry

Funder name

IGEA (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes