I-ONE therapy in patients undergoing total knee arthroplasty

ISRCTN	ISRCTN10526056
DOI	https://doi.org/10.1186/ISRCTN10526056
Protocol serial number	001
Sponsor	IGEA (Italy)
Funders	University of Bari (Italy), IGEA (Italy)

Submission date: 29/10/2010
Registration date: 04/11/2010
Last edited: 18/03/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Biagio Moretti
Scientific

Piazza Giulio Cesare, 11-Bari
Bari
70124
Italy

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	I-ONE therapy in patients undergoing total knee arthroplasty: Prospective and randomised study with a control group
Study acronym	IKA
Study objectives	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(s)	The local ethics committee of the General Hospital of Bari approved in December 2007
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/06/2010

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	30
Key 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°
Key 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
Date of first enrolment	01/01/2008
Date of final enrolment	30/06/2010

Locations

Countries of recruitment

Italy

Study participating centre

Piazza Giulio Cesare, 11-Bari

Bari
70124
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	06/06/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes