I-ONE therapy in patients undergoing total knee arthroplasty

ISRCTN ISRCTN10526056
DOI https://doi.org/10.1186/ISRCTN10526056
Secondary identifying numbers 001
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

Study designProspective randomised controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleI-ONE therapy in patients undergoing total knee arthroplasty: Prospective and randomised study with a control group
Study acronymIKA
Study objectivesTotal 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) studiedKnee arthritis
InterventionPatients 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 typeOther
Primary outcome measurePain 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 measures1. 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 study start date01/01/2008
Completion date30/06/2010

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsfrom 1 to 30
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2008
Date of final enrolment30/06/2010

Locations

Countries of recruitment

  • Italy

Study participating centre

Piazza Giulio Cesare, 11-Bari
Bari
70124
Italy

Sponsor information

IGEA (Italy)
Industry

Via Parmenide, 10/A
Carpi
41012
Italy

Website http://www.igea.it/
ROR logo "ROR" https://ror.org/01bws2668

Funders

Funder type

University/education

University of Bari (Italy)

No information available

IGEA (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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