Intraarticular Gold Microparticles for Knee Osteoarthritis

NCT07202390 | Not Yet Recruiting DMC

• 1 other identifier: GAIN XVI Knee RCT
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Knee Osteoarthritis

Keywords

Intraarticular gold; knee osteoarthritis

Outcome Measures

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

  1 year

Secondary Outcomes (4)

• The PainDetect questionnaire

  1 year

• The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  1 year

• The quality of life score EQ-5D-5L

  1 yar

• Proteomic analysis of synovial fluid and serum

  8 weeks

Study Arms (2)

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.

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

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

Interventions

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.

Intraarticular gold microprarticles plus hyaluronic acid; Intraarticular hyaluronic acid

Intervention OTHER

20 mg metallic gold microparticles (72.000 particles, 20-40 µm) will be injected into the knee joint using 2 mL hyaluronic acid.

Intraarticular gold microprarticles plus hyaluronic acid; Intraarticular hyaluronic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Orthopaedic Division, Denmark: lead
• Aalborg University: collaborator

Related Publications (25)

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MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid; Methods

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Investigative Techniques

Central Study Contacts

Sten Rasmussen, M.D., M.B.A., Ph.D.

CONTACT

25520462; sten@dcm.aau.dk

Allan Stensballe, cand.scient., Ph.D.

CONTACT

61608786; as@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: October 1, 2025
• Study Start: February 1, 2026
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2029
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: February 2029