Knee osteoarthritis (OA). Osteoarthritis (OA) is a debilitating disease which mostly affects people over 60 years of age. It is known to be within the top 10 contributors to years lived with disability worldwide1. The increasing number of patients with symptomatic OA in an ageing population will continue to place an increasingly larger economic burden on global healthcare systems. The knee is a common location for the disease, causing pain, stiffness and problems with sleep and daily activities.
Conditions
Interventions
Trade Name: Depo-Medrone
Product Name: Depo-Medrone
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: METHYLPREDNISOLONE
Other descriptive name: METHYLPREDNISOLONE ACETA
Sponsors
Beacon Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for inclusion, each subject must meet each of the following criteria at Screening (Visit 1) and must continue to fulfil these criteria at Baseline (Visit 2): - Age over 30 years - Mean VAS pain score of >40 of 100 (worst possible pain) over the course of 7 days during the previous month - OA diagnosed by the American College of Rheumatology criteria - Grade 1-3 radiographic OA as defined by the Kellgren-Lawrence classification - Unilateral symptoms - Patient is able to complete trial procedures and complete informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 135 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Knee instability during physical examination (grade II or III) - Pre-treatment VAS pain score of 10 degrees of valgus or varus deviation) - Bilateral symptomatic lesions - Current use of anticoagulant medications or NSAIDs used in the 5 days before blood donation - Recent intra-articular injection of corticosteroids and prior treatment with HA or PRP in the past 6 months - Symptomatic osteoarthritis in the contralateral knee - Allergy/sensitivity to study medications or their ingredients - Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the initial treatment period - Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements - Known history of, or documented positive hepatitis B or C or HIV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the KNiT trial is to evaluate and compare the effectiveness of three injection treatments as a treatment to reduce symptoms in knee osteoarthritis: 1. corticosteroid (CS) 2. platelet-rich plasma (PRP) 3. PRP+hyaluronic acid (PRP+HA) The primary objective of the KNiT trial is to evaluate the effectiveness of the injection treatments to reduce patient reported symptoms, including pain and disability caused by the knee osteoarthritis. This will be assessed using a knee-specific patient reported outcome measure (PROM), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee score.;Secondary Objective: The secondary objective of the KNiT trial is to evaluate the injection treatments can specifically reduce pain, improve quality-of-life and delay the need for surgical treatment (e.g., knee joint replacement). This will be assessed using the EuroQol EQ-5D-5L health related quality-of-life score, and by reporting reasons for drop-out during the study period.;Primary end point(s): WOMAC score: the WOMAC knee score is a 33-question, patient reported, functional outcome measure consisting of 3 domains (Pain: 9 questions; Symptoms & Stiffness: 7 questions; Function daily living: 17 questions). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The WOMAC knee score has been proven to be a robust, practical clinical and research instrument with good responsiveness and acceptability for assessment of knee related OA symptoms.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - WOMAC score - EQ-5D-5L score: the EQ-5D-5L is a validated, patient self-report outcome measure which examines five domains related to daily activities: mobility, self-care, usual activities, pain and discomfort and anxiety and depression. - VAS score: VAS score is a validated, patient self-report outcome measure which examines pain - Rate of adverse events - Rate of additional treatments (e.g. need for additional injections or surgery);Timepoint(s) of evaluation of this end point: 1, 3 and 12 months | — |
Countries
Ireland
Contacts
Public ContactPrincipal Investigator
Beacon Hospital
Outcome results
None listed