Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
001
Study information
Scientific title
I-ONE therapy in patients undergoing total knee arthroplasty: Prospective and randomised study with a control group
Acronym
IKA
Study hypothesis
Total knee arthroplasty (TKA) is often accompanied by a severe inflammatory reaction which, unless controlled, leads to persistent pain up to a year after surgery. Biophysical stimulation with I-ONE therapy has demonstrated to protect articular joint from catabolic activity of pro-inflammatory cytokines.
The aim of this study was to evaluate if patients undergoing TKA could benefit from I-ONE therapy, leading to early control of inflammation and relief of pain resulting in early and complete return to daily activities.
Ethics approval
The local ethics committee of the General Hospital of Bari approved in December 2007
Study design
Prospective randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Knee arthritis
Intervention
Patients undergoing total knee arthroplasty will be randomised to receive either
1. I-ONE therapy, post-surgery, 4 hours/day for 60 days
2. Treatment as usual
The total duration of follow up will be 1 year
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Pain assessed by Visual Analogue Scale (VAS):
A 10 cm horizontal line corresponding to a scale evaluating the pain, where the left end stands for complete absence of pain and the right end the maximum possible pain or unbearable pain.
All outcomes will be assessed at 1, 2, 6 and 12 months.
Secondary outcome measures
1. Knee Society forms, 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 will be assessed at 1, 2, 6 and 12 months.
Overall trial start date
01/01/2008
Overall trial end date
30/06/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Either sex, aged ≥ 60 and < 85
2. Presenting an advanced state of knee arthritis and scheduled for prosthetic replacement
3. Misalignment in varus/valgus respectively not exceeding 20° and 15° and deformity in bending less than 15°
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
from 1 to 30
Participant exclusion criteria
1. Patients who had undergone previous surgery to the same knee or had been operated on for hip prosthesis
2. Patients with BMI >30 Kg/m2
3. Patients with pathological processes such as
3.1. rheumatoid arthritis
3.2. autoimmune conditions
3.3. systemic diseases
3.4. tumours
Recruitment start date
01/01/2008
Recruitment end date
30/06/2010
Locations
Countries of recruitment
Italy
Trial participating centre
Piazza Giulio Cesare, 11-Bari
Bari
70124
Italy
Sponsor information
Organisation
IGEA (Italy)
Sponsor details
Via Parmenide
10/A
Carpi
41012
Italy
Sponsor type
Industry
Website
Funders
Funder type
University/education
Funder name
University of Bari (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22672794
Publication citations
-
Results
Moretti B, Notarnicola A, Moretti L, Setti S, De Terlizzi F, Pesce V, Patella V, I-ONE therapy in patients undergoing total knee arthroplasty: a prospective, randomized and controlled study., BMC Musculoskelet Disord, 2012, 13, 88, doi: 10.1186/1471-2474-13-88.