An observational study in Osteoarthritis, Hip, sponsored by Northern Orthopaedic Division, Denmark. Not yet recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Northern Orthopaedic Division, Denmark · Observational
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.
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).
641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.
This study's planned enrollment of 20 is below the median of 135 across 158 observational studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Northern Orthopaedic Division, Denmark is the lead sponsor of 61 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Radiographically confirmed moderate hip OA .
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intra articular
Also known as: Hyaluronic acid
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.
Time frame: 2 year
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.
Time frame: 2 year
Plan to share: Yes — After the publication of the study
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Available after publication
Access criteria: Will be available at VBN Aalborg University
Start is estimated for Mar 2024; primary completion for Apr 2024, 0 months later.
Of 52 non-industry observational studies under Osteoarthritis, Hip, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 59. This study's planned 0 months is below that.
Counting every sponsor, half of 81 studies reached it within 53 months; a quarter within 13 and three quarters within 113.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Northern Orthopaedic Division, Denmark