Osteoarthritis, Hip
Conditions
Keywords
Hip osteoarthritis, Intra articular gold, Outcome
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, 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).
Interventions
COMBINATION_PRODUCTGold
Intra articular
Sponsors
Aalborg University Hospital
Northern Orthopaedic Division, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC | 2 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PainDetect | 2 year | 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. |
Countries
Denmark
Contacts
Primary ContactSten Rasmussen, MD PhD
Outcome results
None listed