Intraarticular Gold Microparticles for Knee Osteoarthritis
ConditionKnee Osteoarthritis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthern Orthopaedic Division, Denmark
About this trial
The investigators have shown in three pilot studies that intra-articular metallic gold microparticles can reduce knee osteoarthritis pain for up to two years. These results are noteworthy considering the growing number of older adults who suffer from osteoarthritis pain, which contributes to increased demand on healthcare resources. Demonstrating effective treatment could alleviate this burden for a significant portion of the aging population.
The specific aim is to evaluate whether intra-articular metallic gold microparticles are superior to placebo in reducing the need for additional treatment in patients with knee osteoarthritis within one year. The investigators will test the hypothesis that intra-articular metallic gold microparticles reduce subsequent treatment events by more than 50% compared to placebo during this period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
more than 6 months of knee pain without efficacy on pain of conservative treatment, radiographic knee osteoarthritis according to Kellgren-Lawrence grade 1-4, and age ≥18years
Disqualifiers
malalignment, indication for knee replacement surgery, malignancy, active infection and antibiotic treatment, active treatment with steroids, biological or other anti-Rheumatic medication, inability to comply with the protocol, inadequacy in the written and spoken national language
Trial design
Design model
Factorial
Treatments tested in this trial
20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid.
Other intervention20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid.
Intervention
Other intervention20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Intraarticular gold microprarticles plus hyaluronic acidExperimental treatment 2 interventions
Group B: Intraarticular hyaluronic acidPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
The primary outcome is any additional treatment event such as, re-referral, intra-articular injection, arthroscopy or any knee replacement surgery within 1 year.
Time to event
Time frame
1 yearSecondary outcomes
1
The PainDetect questionnaire
The PainDetect questionnaire (Freynhagen et al., 2006) includes three components: gradation of pain, pain course pattern, and radiating pain. Gradation is measured by seven patient-scored questions on a 0 to 5 scale (0 = never; 5 = very strongly). Pain course pattern is assessed with one question where patients select one of four images, each representing a specific score (0, -1, or +1; two images may score +1). Radiating pain is determined by a yes (score +2) or no (score 0) response. Total scores span from -1 (no pain symptoms) to 38 (severe pain symptoms).
Time frame
1 year2
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The WOMAC questionnaire includes 24 questions: 5 for pain, 2 for stiffness, and 17 for physical function, each scored on a 5-point scale from 0 (none) to 4 (extreme). The summarized score span from 0 (no symptoms) to 96 (severe symptoms).
Time frame
1 year3
The quality of life score EQ-5D-5L
The EQ-5D-5L (33) consists of two parts, a descriptive system and the EQ VAS. The descriptive system measures five dimensions of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the five dimensions can be combined in a 5-digit code that describes the respondent's health state profile; for instance, 21111 means slight problems in the mobility dimension and no problems in any of the other dimensions. The EQ VAS records the respondent's overall current health on a vertical visual analogue scale from 0 to 100, where "0" is "The best health you can imagine" and 100 "The worst health you can imagine
Time frame
1 yar4
Proteomic analysis of synovial fluid and serum
The analyses of the proteomic primary raw data output from synovial fluid and serum obtained before and 8 weeks after treatment in both arms will be searched against spectral databases generated by fractionated pooled samples using human reference proteome database in Biognosys Spectronaut (Schaab et al., 2012) and using statistical analysis (Koh et al., 2019). Quantitative proteome analysis of synovial and serum samples will be accomplished by discovery proteomics using DIA-PASEF (Meier et al., 2020). Functional association of significantly regulated proteins in synovial fluid and serum with gene ontology and function will be asessed by Metascape.
Time frame
8 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Northern Orthopaedic Division, Denmark
Lead sponsor
Aalborg University Hospital
Sponsor institution
Aalborg University
Collaborator
Source ClinicalTrials.gov
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