Evaluation of I-ONE therapy in patients undergoing total knee arthoplasty

Evaluation of I-ONE therapy in patients undergoing total knee arthoplasty: a prospective randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN98459871

Enrollment

Registered

2013-02-27

Start date

2008-02-01

Completion date

Unknown

Last updated

2017-07-03

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

Conditions

Knee osteoarthritis Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]

Interventions

Patients who satisfy inclusion criteria, and receiving a cemented postero-stabilized (PS) TKA with patella resurfacing, are randomised in two groups: 1. Experimental group: standard rehabilitation pro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female patients aged between 60 and 85 2. Presenting with an advanced state of knee OA and scheduled for TKA, with varus or valgus deformity not exceeding 20° or 15°, respectively, and with a flexion contracture of less than 15°

Exclusion criteria

Exclusion criteria: 1. Previous surgery to the same knee 2. Omolateral hip prosthesis 3. Body Mass Index (BMI; kg/m2) >30 4. Rheumatoid arthritis 5. Autoimmune diseases 6. Systemic diseases 7. Cancer and the use of steroids

Design outcomes

Primary

Measure	Time frame
Pain, measured using the Visual Analogue Scale (VAS) at baseline, 1, 2, 6 and 36 months	—

Secondary

Measure	Time frame
1. Knee Society Score, involving a clinical evaluation, Knee Score (which assesses pain, range of motion, stability, contracture in bending, active extension deficit, alignment) and a functional evaluation, Functional Score (which examines autonomy in walking, climbing stairs, use of stick or frame) 2. Functional evaluation scale SF-36, which 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, measured with a scale that quantifies 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 assessed at 1, 2, and 6 months. 5. Pain and functional outcomes (modified from KSS) at 36 months	—

Measure

Time frame

1. Knee Society Score, involving a clinical evaluation, Knee Score (which assesses pain, range of motion, stability, contracture in bending, active extension deficit, alignment) and a functional evaluation, Functional Score (which examines autonomy in walking, climbing stairs, use of stick or frame) 2. Functional evaluation scale SF-36, which 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, measured with a scale that quantifies 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 assessed at 1, 2, and 6 months. 5. Pain and functional outcomes (modified from KSS) at 36 months

—

Countries

Italy

Outcome results

None listed

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