Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06186115
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-12-16
Brief Title:
Intraarticular Gold Microparticles for Hip Osteoarthritis
Sponsor:
Northern Orthopaedic Division Denmark
Organization:
Northern Orthopaedic Division Denmark
Study Overview
Official Title:
Intraarticular Gold Microparticles for Hip Osteoarthritis - a 2-year Follow-up Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed 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 72000 pieces 20-40 ยต-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None