Intraarticular Gold Microparticles for Hip Osteoarthritis

NCT ID: NCT06186115

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-04

Study Completion Date

2024-05-01

Brief Summary

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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.

Detailed Description

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A cohort of 20 patients, aged ≥ 18 years, with pain ≥ 3 months, and Kellgren-Lawrence OA grade 2-4, will beincluded. Metallic gold 20 mg, 72.000 pieces, 20-40 µ-meter (Berlock-Micro-Implants, HumanGoldInject) (1) were injected into the hip joint using hyaluronic acid as the carrier. In total, we treated 24 hip joints. The primary outcome was the Western Ontario and McMaster Universities Arthritis Index (WOMAC).

Conditions

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Osteoarthritis, Hip

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Gold

Intra articular

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Hyaluronic acid

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role collaborator

Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Sten Rasmussen, MD, PhD

Professor Head of Department of Clinical Medicine, Aalborg University, Denmark

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sten Rasmussen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Northern ODD

Locations

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Aalborg University Hospital

Aalborg, Region Northern Jutland, Denmark

Site Status

Countries

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Denmark

Central Contacts

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Sten Rasmussen, MD PhD

Role: CONTACT

+4525520462

References

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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.

Reference Type BACKGROUND
PMID: 35076138 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36864314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36921973 (View on PubMed)

Related Links

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Other Identifiers

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ArthroGold-6

Identifier Type: -

Identifier Source: org_study_id

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