Condition category
Musculoskeletal Diseases
Date applied
29/10/2010
Date assigned
04/11/2010
Last edited
18/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Biagio Moretti

ORCID ID

Contact details

Piazza Giulio Cesare
11-Bari
Bari
70124
Italy

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

http://www.igea.it/

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

  1. 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.

Additional files

Editorial Notes