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ISRCTN
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ISRCTN98459871
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DOI
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10.1186/ISRCTN98459871
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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PITTKA (Post-operative I-One Therapy Total Knee Arthoplasty): Evaluation of I-ONE therapy in patients undergoing total knee arthoplasty
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Scientific title
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Evaluation of I-ONE therapy in patients undergoing total knee arthoplasty: a prospective randomised controlled group trial
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Acronym
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PITTKA
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Serial number at source
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v.01_2013
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Study hypothesis
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Total knee arthroplasty (TKA) is often associated with a severe local inflammatory reaction which, unless controlled, leads to persistent pain up to one year after surgery. Standard and accelerated rehabilitation protocols are currently being implemented after TKA, but no consensus exists regarding the long-term effects. Biophysical stimulation with pulsed electromagnetic fields (PEMFs) has been demonstrated to exert an anti-inflammatory effect, to promote early functional recovery and to maintain a positive long-term effect in patients undergoing joint arthroscopy.
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Lay summary
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Lay summary under review 1
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Ethics approval
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The IRB of the Clinic "Città di Parma" (italy) approved the protocol in January 2008.
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Study design
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Prospective randomised controlled group trial
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Countries of recruitment
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Italy
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Disease/condition/study domain
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Knee osteoarthritis
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Participants - inclusion criteria
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1. Male and female patients aged between 60 and 85 years
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°.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/02/2008
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Anticipated end date
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31/12/2012
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please contact segreteria@paoloadravanti.com to request a patient information sheet
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Target number of participants
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From 1 to 33
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Interventions
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Patients who satisfy inclusion criteria, receiving a cemented postero-stabilized (PS) TKA with patella resurfacing, randomised in two groups:
1. Experimental group: standard rehabilitation protocol + I-ONE therapy, post-surgery (within one week), 4 hours/day for 60 days
2. Control group: standard rehabilitation protocol
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Primary outcome measure(s)
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Pain, measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain) at baseline, 1, 2, 6 and 36 months.
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Secondary outcome measure(s)
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1. Knee Society Score, 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 assessed at 1, 2, and 6 months.
5. Pain and functional outcomes (modified from KSS) at 36 months
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Sources of funding
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IGEA (Italy)
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Trial website
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Publications
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Contact name
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Dr
Paolo
Adravanti
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Address
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Piazza Maestri 5
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City/town
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Parma
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Zip/Postcode
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43100
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Country
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Italy
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Sponsor
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IGEA S.p.A (Italy)
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Address
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Via Parmenide, 10/A
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City/town
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Carpi
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Zip/Postcode
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41012
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Country
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Italy
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Email
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s.setti@igeamedical.com
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Sponsor website:
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http://www.igeamedical.com
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Date applied
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15/02/2013
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Last edited
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27/02/2013
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Date ISRCTN assigned
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27/02/2013
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