I-ONE therapy in patients undergoing total knee arthroplasty

Completed

Conditions: Knee arthritis
Musculoskeletal Diseases
Gonarthrosis [arthrosis of knee]

Registration Number: ISRCTN10526056

Lead Sponsor: IGEA (Italy)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain assessed by Visual Analogue Scale (VAS):<br>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.<br><br>All outcomes will be assessed at 1, 2, 6 and 12 months.

Secondary Outcome Measures

Name	Time	Method
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.<br>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.<br>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.<br>4. Monitoring of assumption of NSAIDs at all follow-ups<br><br>All outcomes will be assessed at 1, 2, 6 and 12 months.