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
Scientific
Piazza Giulio Cesare, 11-Bari
Bari
70124
Italy
Study information
| Study design | Prospective randomised controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 01/01/2008 |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | from 1 to 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
70124
Italy
Sponsor information
IGEA (Italy)
Industry
Industry
Via Parmenide, 10/A
Carpi
41012
Italy
| Website | http://www.igea.it/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
