I-ONE therapy in patients undergoing total knee arthroplasty

I-ONE therapy in patients undergoing total knee arthroplasty: Prospective and randomised study with a control group

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10526056

Enrollment

Registered

2010-11-04

Start date

2008-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee arthritis Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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°

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026