Hip OANCT07883395
Post-Market Clinical Follow-up of Intra-Articular Hyaluronic Acid in Hip Osteoarthritis
An observational study of Hip OA, run by Meiji Pharma Spain S.A. at 4 sites in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hip OA
- How many people
- 40 participants
- Where
- 4 sitesSpain
- Study dates
- 29 Jan 2026to Apr 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult outpatients (>40 years) with symptomatic hip osteoarthritis (Kellgren-Lawrence II-III) receiving intra-articular hyaluronic acid.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitario de La Princesa
Madrid
Dr. J Del Río, +34 915 202 282, juliandel.rio@salud.madrid.org
- Recruiting
Hospital Universitario de La Princesa
Madrid
Dr. MJ Arriaza, +34 915 20 22 00, mariajose.arriaza@salud.madrid.org
- Recruiting
QuironSalud. Hospital Juan Bravo
Madrid
Dr. J Del Río, +34 910 687 999, julian.delrio@quironsalud.es
- Not yet recruiting
Hospital Provincial Nuestra Señora de Gracia
Zaragoza
Dr. A Santamaría, +34 976 44 00 22, asantamariato@salud.aragon.es
About this study
Official title: 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.
- Conditions
- Hip OA
- Keywords
- hip osteoarthritis, hyaluronic acid, intraarticular injection, Viscosupplementation
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid (HA) | Patients with hip osteoarthritis treated with HA under real-world clinical practice conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in self-reported hip pain severityu as measured by Visual Analog Scale (VAS) Pain Score at 12 months
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.
Measured: Baseline (pre-treatment), 3 months and 12 months post-treatment
Secondary outcomes (4)
Change from Baseline in hip osteoarthritis symptoms as measured by WOMAC Osteoarthritis Index Total Score
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.
Measured: Baseline, Month 3, and Month 12
Change from Baseline in hip joint function as measured by Modified Harris Hip Score (mHHS)
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.
Measured: 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)
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.
Measured: Baseline and Month 12
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percentage of participants experiencing adverse events and serious adverse events related or unrelated to intra-articular hyaluronic acid treatment throughout the follow-up period.
Measured: From baseline up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start29 Jan 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meiji Pharma Spain S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Quironsalud, Hospital Provincial Nuestra Señora de Gracia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883395
- Sponsor's protocol ID
- MPS-ADAP/03
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No