Knee OsteoarthritisNCT07202390
Intraarticular Gold Microparticles for Knee Osteoarthritis
A study testing 20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid. and Intervention in people with Knee Osteoarthritis, run by Northern Orthopaedic Division, Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- 20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid. and Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intraarticular Gold Microparticles for Knee Osteoarthritis. A Randomized 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.
Read the detailed description
To test the superiority of metallic gold microparticles over a placebo, 240 patients will be included in a randomized, double-blind, controlled trial. This process will take place over a period of 1-2 years. The study will follow the CONSORT Guidelines and comply with the Danish Data Protection Agency. The investigators will handle all data in an electronic form, including demographics and all outcome measures. The investigators will use an electronic Case Report Form (CRF). The management of data will be handled according to the Danish Data Protection Agency's guidelines. The host for data will be physically located at Aalborg University Research Data host, and at North Denmark Region, q-drive host, and follow the Guidelines from The Danish Protection Agency. The schedule for randomization will be randomly generated using a computer before the initiation of the trial. The medical doctor will be blind to group allocation and will not be involved in providing the metallic gold microparticles or placebo. The participants and the medical doctor performing follow-up will be blind to group allocation.
All patients will receive either intra-articular metallic gold microparticles and HA or HA alone. With the use of 2 cc syringe, the investigators will perform intra-articular injection using the standard approach for knee puncture and injection. For intervention, 20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the joint using 2 mL hyaluronic acid. For control, 2 mL of hyaluronic acid will be injected into the joint. A centralized computer-generated randomization will allocate to either 2 cc of hyaluronic acid with or without 20 mg metallic gold microparticles.
At the end of the trial, the patients in the control group will receive the intervention treatment with metallic gold microparticles.
- Conditions
- Knee Osteoarthritis
- Being tested
- 20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid., Intervention
- Keywords
- Intraarticular gold; knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid.Other
20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid.
InterventionOther
20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid.
| Study group | Role | What they receive |
|---|---|---|
| Intraarticular gold microprarticles plus hyaluronic acid | Experimental | 20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid. Receives: Other: 20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid.; Other: Intervention |
| Intraarticular hyaluronic acid | Placebo comparator | 2 mL hyaluronic acid will be injected into the knee joint Receives: Other: 20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid.; Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (4)
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).
Measured: 1 year
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).
Measured: 1 year
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
Measured: 1 yar
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Sten Rasmussen, MD, PhD, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202390
- Sponsor's protocol ID
- GAIN XVI Knee RCT
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the publication of the study:
Publications
Barfod KW, Blond L, Mikkelsen RK, Bagge J, Holmich LR, Kallemose T, Troelsen A, Holmich P. Treatment of knee osteoarthritis with a single injection of autologous micro-fragmented adipose tissue is not superior to a placebo saline injection: a blinded randomised controlled trial with 2-year follow-up. Br J Sports Med. 2025 Aug 26;59(17):1219-1227. doi: 10.1136/bjsports-2024-108732.
PubMed 40101939Kim KI, Kim MS, Kim JH. Intra-articular Injection of Autologous Adipose-Derived Stem Cells or Stromal Vascular Fractions: Are They Effective for Patients With Knee Osteoarthritis? A Systematic Review With Meta-analysis of Randomized Controlled Trials. Am J Sports Med. 2023 Mar;51(3):837-848. doi: 10.1177/03635465211053893. Epub 2022 Jan 12.
PubMed 35019764Peck J, Slovek A, Miro P, Vij N, Traube B, Lee C, Berger AA, Kassem H, Kaye AD, Sherman WF, Abd-Elsayed A. A Comprehensive Review of Viscosupplementation in Osteoarthritis of the Knee. Orthop Rev (Pavia). 2021 Jul 10;13(2):25549. doi: 10.52965/001c.25549. eCollection 2021.
PubMed 34745480Pereira TV, Juni P, Saadat P, Xing D, Yao L, Bobos P, Agarwal A, Hincapie CA, da Costa BR. Viscosupplementation for knee osteoarthritis: systematic review and meta-analysis. BMJ. 2022 Jul 6;378:e069722. doi: 10.1136/bmj-2022-069722.
PubMed 36333100Richard MJ, Driban JB, McAlindon TE. Pharmaceutical treatment of osteoarthritis. Osteoarthritis Cartilage. 2023 Apr;31(4):458-466. doi: 10.1016/j.joca.2022.11.005. Epub 2022 Nov 19.
PubMed 36414224Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.
PubMed 31278997Altman RD, Devji T, Bhandari M, Fierlinger A, Niazi F, Christensen R. Clinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments: A systematic review and meta-analysis of randomized trials. Semin Arthritis Rheum. 2016 Oct;46(2):151-159. doi: 10.1016/j.semarthrit.2016.04.003. Epub 2016 Apr 27.
PubMed 27238876Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8.
PubMed 23299850Bellamy N, Campbell J, Robinson V, Gee T, Bourne R, Wells G. Intraarticular corticosteroid for treatment of osteoarthritis of the knee. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005328. doi: 10.1002/14651858.CD005328.pub2.
PubMed 16625636Chavda S, Rabbani SA, Wadhwa T. Role and Effectiveness of Intra-articular Injection of Hyaluronic Acid in the Treatment of Knee Osteoarthritis: A Systematic Review. Cureus. 2022 Apr 26;14(4):e24503. doi: 10.7759/cureus.24503. eCollection 2022 Apr.
PubMed 35651409Bhandari M, Bannuru RR, Babins EM, Martel-Pelletier J, Khan M, Raynauld JP, Frankovich R, Mcleod D, Devji T, Phillips M, Schemitsch EH, Pelletier JP. Intra-articular hyaluronic acid in the treatment of knee osteoarthritis: a Canadian evidence-based perspective. Ther Adv Musculoskelet Dis. 2017 Sep;9(9):231-246. doi: 10.1177/1759720X17729641. Epub 2017 Sep 12.
PubMed 28932293Concoff A, Sancheti P, Niazi F, Shaw P, Rosen J. The efficacy of multiple versus single hyaluronic acid injections: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2017 Dec 21;18(1):542. doi: 10.1186/s12891-017-1897-2.
PubMed 29268731Skou ST, Rasmussen S, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Roos EM. The efficacy of 12 weeks non-surgical treatment for patients not eligible for total knee replacement: a randomized controlled trial with 1-year follow-up. Osteoarthritis Cartilage. 2015 Sep;23(9):1465-75. doi: 10.1016/j.joca.2015.04.021. Epub 2015 Apr 30.
PubMed 25937024Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Rasmussen S. A Randomized, Controlled Trial of Total Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1597-606. doi: 10.1056/NEJMoa1505467.
PubMed 26488691Zhang Z, Hu Z, Zhao D, Huang H, Liang Y, Mao B. Arthroscopic surgery is not superior to conservative treatment in knee osteoarthritis: a systematic review and meta-analysis of randomized controlled trails. BMC Musculoskelet Disord. 2024 Sep 5;25(1):712. doi: 10.1186/s12891-024-07813-3.
PubMed 39237972
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraarticular Gold Microparticles for Knee Osteoarthritis. A Randomized Trial
- ClinicalTrials.gov ID
- NCT07202390
- Acronym / sponsor ID
- GAIN XVI Knee RCT
- Conditions
- Knee Osteoarthritis
- Keywords
- Intraarticular gold; knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To test the superiority of metallic gold microparticles over a placebo, 240 patients will be included in a randomized, double-blind, controlled trial. This process will take place over a period of 1-2 years. The study will follow the CONSORT Guidelines and comply with the Danish Data Protection Agency. The investigators will handle all data in an electronic form, including demographics and all outcome measures. The investigators will use an electronic Case Report Form (CRF). The management of data will be handled according to the Danish Data Protection Agency's guidelines. The host for data will be physically located at Aalborg University Research Data host, and at North Denmark Region, q-drive host, and follow the Guidelines from The Danish Protection Agency. The schedule for randomization will be randomly generated using a computer before the initiation of the trial. The medical doctor will be blind to group allocation and will not be involved in providing the metallic gold microparticles or placebo. The participants and the medical doctor performing follow-up will be blind to group allocation.
All patients will receive either intra-articular metallic gold microparticles and HA or HA alone. With the use of 2 cc syringe, the investigators will perform intra-articular injection using the standard approach for knee puncture and injection. For intervention, 20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the joint using 2 mL hyaluronic acid. For control, 2 mL of hyaluronic acid will be injected into the joint. A centralized computer-generated randomization will allocate to either 2 cc of hyaluronic acid with or without 20 mg metallic gold microparticles.
At the end of the trial, the patients in the control group will receive the intervention treatment with metallic gold microparticles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraarticular gold microprarticles plus hyaluronic acid | Experimental | Other: 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. |
| Intraarticular hyaluronic acid | Placebo comparator | Other: 20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid., Other: Intervention2 mL hyaluronic acid will be injected into the knee joint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid.20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid. | Other | Intraarticular gold microprarticles plus hyaluronic acid, Intraarticular hyaluronic acid |
| Intervention20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid. | Other | Intraarticular gold microprarticles plus hyaluronic acid, Intraarticular hyaluronic acid |
Primary outcome
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 frame: 1 year
Time to event
4 secondary outcomes
The PainDetect questionnaire
Time frame: 1 year
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 1 year
The quality of life score EQ-5D-5L
Time frame: 1 yar
Proteomic analysis of synovial fluid and serum
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Background: PubMed 40101939Barfod KW, Blond L, Mikkelsen RK, Bagge J, Holmich LR, Kallemose T, Troelsen A, Holmich P. Treatment of knee osteoarthritis with a single injection of autologous micro-fragmented adipose tissue is not superior to a placebo saline injection: a blinded randomised controlled trial with 2-year follow-up. Br J Sports Med. 2025 Aug 26;59(17):1219-1227. doi: 10.1136/bjsports-2024-108732.
- Background: PubMed 35019764Kim KI, Kim MS, Kim JH. Intra-articular Injection of Autologous Adipose-Derived Stem Cells or Stromal Vascular Fractions: Are They Effective for Patients With Knee Osteoarthritis? A Systematic Review With Meta-analysis of Randomized Controlled Trials. Am J Sports Med. 2023 Mar;51(3):837-848. doi: 10.1177/03635465211053893. Epub 2022 Jan 12.
- Background: PubMed 34745480Peck J, Slovek A, Miro P, Vij N, Traube B, Lee C, Berger AA, Kassem H, Kaye AD, Sherman WF, Abd-Elsayed A. A Comprehensive Review of Viscosupplementation in Osteoarthritis of the Knee. Orthop Rev (Pavia). 2021 Jul 10;13(2):25549. doi: 10.52965/001c.25549. eCollection 2021.
- Background: PubMed 36333100Pereira TV, Juni P, Saadat P, Xing D, Yao L, Bobos P, Agarwal A, Hincapie CA, da Costa BR. Viscosupplementation for knee osteoarthritis: systematic review and meta-analysis. BMJ. 2022 Jul 6;378:e069722. doi: 10.1136/bmj-2022-069722.
- Background: PubMed 36414224Richard MJ, Driban JB, McAlindon TE. Pharmaceutical treatment of osteoarthritis. Osteoarthritis Cartilage. 2023 Apr;31(4):458-466. doi: 10.1016/j.joca.2022.11.005. Epub 2022 Nov 19.
- Background: PubMed 31278997Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.
- Background: PubMed 27238876Altman RD, Devji T, Bhandari M, Fierlinger A, Niazi F, Christensen R. Clinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments: A systematic review and meta-analysis of randomized trials. Semin Arthritis Rheum. 2016 Oct;46(2):151-159. doi: 10.1016/j.semarthrit.2016.04.003. Epub 2016 Apr 27.
- Background: PubMed 23299850Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8.
- Background: PubMed 16625636Bellamy N, Campbell J, Robinson V, Gee T, Bourne R, Wells G. Intraarticular corticosteroid for treatment of osteoarthritis of the knee. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005328. doi: 10.1002/14651858.CD005328.pub2.
- Background: PubMed 35651409Chavda S, Rabbani SA, Wadhwa T. Role and Effectiveness of Intra-articular Injection of Hyaluronic Acid in the Treatment of Knee Osteoarthritis: A Systematic Review. Cureus. 2022 Apr 26;14(4):e24503. doi: 10.7759/cureus.24503. eCollection 2022 Apr.
- Background: PubMed 28932293Bhandari M, Bannuru RR, Babins EM, Martel-Pelletier J, Khan M, Raynauld JP, Frankovich R, Mcleod D, Devji T, Phillips M, Schemitsch EH, Pelletier JP. Intra-articular hyaluronic acid in the treatment of knee osteoarthritis: a Canadian evidence-based perspective. Ther Adv Musculoskelet Dis. 2017 Sep;9(9):231-246. doi: 10.1177/1759720X17729641. Epub 2017 Sep 12.
- Background: PubMed 29268731Concoff A, Sancheti P, Niazi F, Shaw P, Rosen J. The efficacy of multiple versus single hyaluronic acid injections: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2017 Dec 21;18(1):542. doi: 10.1186/s12891-017-1897-2.
- Individual participant dataSharing planned: Yes. After the publication of the study:
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing 20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid. and Intervention in people with Knee Osteoarthritis, run by Northern Orthopaedic Division, Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sten Rasmussen, M.D., M.B.A., Ph.D. (25520462 ext. +45, sten@dcm.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07202390, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.