Post-Market Clinical Follow-up of Intra-Articular Hyaluronic Acid in Hip Osteoarthritis
Clinical Follow-up Study of Patients With Hip Osteoarthritis Treated With Intra-Articular Hyaluronic Acid
The study population consists of approximately 40 adult outpatients aged 40 years or older with symptomatic hip osteoarthritis of at least 1 year of clinical evolution, treated with intra-articular hyaluronic acid in routine clinical practice within the Traumatology and Rehabilitation departments of participating hospitals in Spain.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
-
-
-
Madrid, Spanien
- Rekruttering
- Hospital Universitario de La Princesa
-
Kontakt:
- Dr. J Del Río
- Telefonnummer: +34 915 202 282
- E-mail: juliandel.rio@salud.madrid.org
-
Kontakt:
- Dr. MJ Arriaza
- Telefonnummer: +34 915 20 22 00
- E-mail: mariajose.arriaza@salud.madrid.org
-
Madrid, Spanien
- Rekruttering
- QuironSalud. Hospital Juan Bravo
-
Kontakt:
- Dr. J Del Río
- Telefonnummer: +34 910 687 999
- E-mail: julian.delrio@quironsalud.es
-
Zaragoza, Spanien
- Rekruttering
- Hospital Provincial Nuestra Señora de Gracia
-
Kontakt:
- Dr. A Santamaría
- Telefonnummer: +34 976 44 00 22
- E-mail: asantamariato@salud.aragon.es
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Adult outpatients (>40 years) with symptomatic hip osteoarthritis (Kellgren-Lawrence II-III) receiving intra-articular hyaluronic acid.
Beskrivelse
Inclusion Criteria:
- Age: >40 years at the time of study inclusion
- Preserved gait capability, with or without assistive devices
- Symptomatic hip arthropathy with a disease evolution of at least 1 year.
- Radiographic Kellgren-Lawrence grade II-III documented within the 12 months prior to study entry
- Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score >15
- Patient currently receiving intra-articular hyaluronic acid treatment within 3 months prior to study inclusion
Exclusion Criteria:
- Refusal to provide written informed consent
- Females who are pregnant, breastfeeding, or not using effective contraception
- Body Mass Index (BMI) ≥ 30 kg/m²
- Presence of other chronic or autoimmune diseases that could interfere with clinical evaluation
- History of hypersensitivity or allergy to hyaluronic acid or its derivatives
- Prior administration of intra-articular platelet-rich plasma (PRP) or intra-articular corticosteroids within 3 months, or intra-articular hyaluronic acid within 6 months prior to study entry
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Hyaluronic acid (HA)
Patients with hip osteoarthritis treated with HA under real-world clinical practice conditions |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in self-reported hip pain severityu as measured by Visual Analog Scale (VAS) Pain Score at 12 months
Tidsramme: Baseline (pre-treatment), 3 months and 12 months post-treatment
|
Assessment of patient-reported hip pain severity on a VAS, consisting of a 100mm horizontal line ranging from 0 mm (no pain) to 100 mm (worst imaginable pain). Higher scores indicate greater pain intensity; a negative change score reflects pain reduction. |
Baseline (pre-treatment), 3 months and 12 months post-treatment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in hip osteoarthritis symptoms as measured by WOMAC Osteoarthritis Index Total Score
Tidsramme: Baseline, Month 3, and Month 12
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) evaluating hip pain, stiffness, and physical function. Total score ranges from 0 to 96 points, where higher scores indicate worse symptom severity and greater physical disability. |
Baseline, Month 3, and Month 12
|
|
Change from Baseline in hip joint function as measured by Modified Harris Hip Score (mHHS)
Tidsramme: Baseline, Month 3, and Month 12
|
Clinician- and patient-assessed standardized scale evaluating hip joint pain, gait, daily activities, and range of motion. Total score ranges from 0 to 100 points, where higher scores indicate superior hip joint function. |
Baseline, Month 3, and Month 12
|
|
Change from Baseline in health-related quality of life as measured by the 12-Item Short Form Health Survey (SF-12)
Tidsramme: Baseline and Month 12
|
Assessment of physical and mental health-related quality of life dimensions using the 12-Item Short Form Health Survey (SF-12). Standardized scores range from 0 to 100 points, where higher scores represent better health-related quality of life. |
Baseline and Month 12
|
|
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: From baseline up to Month 12
|
Percentage of participants experiencing adverse events and serious adverse events related or unrelated to intra-articular hyaluronic acid treatment throughout the follow-up period. |
From baseline up to Month 12
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MPS-ADAP/03
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .