Intraarticular Gold Microparticles for Hip Osteoarthritis

NCT06186115 | Unknown DMC

• 1 other identifier: ArthroGold-6
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In a pilot study, the investigators recently showed that intraarticular metallic gold microparticles reduce knee osteoarthritis pain for up to two years and found associated significant proteomic changes in serum and synovial fluid within eight weeks. This study aim to evaluate the outcome after intra-articular injection of gold microparticles for hip osteoarthritis.

Conditions

Osteoarthritis, Hip

Keywords

Hip osteoarthritis; Intra articular gold; Outcome

Outcome Measures

Primary Outcomes (1)

• WOMAC

  Western Ontario and McMaster Universities Arthritis Index, sub-scores for pain, stiffness, and function, containing 24 questions: 5 pain questions, two stiffness questions, and 17 physical function questions.

  2 year

Secondary Outcomes (1)

• PainDetect

  2 year

Interventions

Gold COMBINATION_PRODUCT

Intra articular

Also known as: Hyaluronic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Radiographically confirmed moderate hip OA .

You may qualify if:

• confirmed moderate hip OA (Kellgren-Lawrence grade ≥ 2), pain for more than 3 months, and maximal pain intensity VAS (Visual Analogue Scale, 0-10) ≥ 5 during the last week

Sponsors & Collaborators

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

Study Sites (1)

Aalborg University Hospital

Aalborg, Region Northern Jutland, 9000, Denmark

Location

Related Publications (3)

• Rasmussen S, Kjaer Petersen K, Kristiansen MK, Skallerup J, Aboo C, Thomsen ME, Skjoldemose E, Jorgensen NK, Stensballe A, Arendt-Nielsen L. Gold micro-particles for knee osteoarthritis. Eur J Pain. 2022 Apr;26(4):811-824. doi: 10.1002/ejp.1909. Epub 2022 Feb 1.

  PMID: 35076138 BACKGROUND

• Danscher G, Rasmussen S. nanoGold and microGold inhibit autoimmune inflammation: a review. Histochem Cell Biol. 2023 Mar;159(3):225-232. doi: 10.1007/s00418-023-02182-9. Epub 2023 Mar 2.

  PMID: 36864314 BACKGROUND

• Rasmussen S, Frederickson C, Danscher G. Inhibition of Local Inflammation by Implanted Gold: A Narrative Review of the History and Use of Gold. J Rheumatol. 2023 May;50(5):704-705. doi: 10.3899/jrheum.221150. Epub 2023 Mar 15. No abstract available.

  PMID: 36921973 BACKGROUND

Related Links

• Sten Rasmussen

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Gold; Hyaluronic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Sten Rasmussen, MD PhD

  Northern ODD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sten Rasmussen, MD PhD

CONTACT

+4525520462; sten@dcm.aau.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Head of Department of Clinical Medicine, Aalborg University, Denmark

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: December 29, 2023
• Study Start: March 4, 2024
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Available after publication
• Access Criteria: Will be available at VBN Aalborg University

Locations

DK (1)