Intraarticular Gold Microparticles for Hip Osteoarthritis

Osteoarthritis, Hip Clinical Trial

Official title:

Intraarticular Gold Microparticles for Hip Osteoarthritis - a 2-year Follow-up Pilot Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06186115
• Other study ID #: ArthroGold-6
• Status: Not yet recruiting
• Start date: March 4, 2024
• Est. completion date: May 1, 2024

Study information

• Verified date: January 2024
• Source: Northern Orthopaedic Division, Denmark
• Contact: Sten Rasmussen, MD PhD
• Phone: +4525520462
• Email: sten[@]dcm.aau.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• exclusion criteria were 1) malignancy, 2) active infection and antibiotic treatment, 3) active treatment with steroids, biological or other anti-rheumatic medication, 4) history of chronic pain condition, 5) inability to comply with the protocol, and 6) inadequacy in written and spoken national language.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Combination Product:
• Gold
Intra articular

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg	Region Northern Jutland

Sponsors (2)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark	Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PainDetect	The secondary outcome measure PainDetect questionnaire (PDQ) comprises three major components, gradation of pain, pain course pattern, and radiating pain. Seven questions evaluate the gradation of pain. The patient scored each question using a 0 to 5 score with 0 = never, 1 = hardly noticed, 2 = slightly, 3 = moderately, 4 = strongly and 5 = very strongly. There is one question evaluating pain course patterns. Patients select from one of four pictures indicating which pattern best describes their course of pain. Each picture has a unique score of 0, -1, or +1 (2 pictures have this score possible). One question evaluates radiating pain with a yes (score of +2) or no (score of 0) response option. PDQ is scored from 0 to 38, with total scores < 13 considered to represent nociceptive pain, 13-18 possible neuropathic pain, and > 18 representing neuropathic pain.	2 year

External Links

•   Sten Rasmussen