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.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究場所
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-
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Madrid、スペイン
- 募集
- Hospital Universitario de La Princesa
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コンタクト：
- Dr. J Del Río
- 電話番号：+34 915 202 282
- メール：juliandel.rio@salud.madrid.org
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コンタクト：
- Dr. MJ Arriaza
- 電話番号：+34 915 20 22 00
- メール：mariajose.arriaza@salud.madrid.org
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Madrid、スペイン
- 募集
- QuironSalud. Hospital Juan Bravo
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コンタクト：
- Dr. J Del Río
- 電話番号：+34 910 687 999
- メール：julian.delrio@quironsalud.es
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Zaragoza、スペイン
- 募集
- Hospital Provincial Nuestra Señora de Gracia
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コンタクト：
- Dr. A Santamaría
- 電話番号：+34 976 44 00 22
- メール：asantamariato@salud.aragon.es
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Adult outpatients (>40 years) with symptomatic hip osteoarthritis (Kellgren-Lawrence II-III) receiving intra-articular hyaluronic acid.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
|---|
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Hyaluronic acid (HA)
Patients with hip osteoarthritis treated with HA under real-world clinical practice conditions |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in self-reported hip pain severityu as measured by Visual Analog Scale (VAS) Pain Score at 12 months
時間枠：Baseline (pre-treatment), 3 months and 12 months post-treatment
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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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in hip osteoarthritis symptoms as measured by WOMAC Osteoarthritis Index Total Score
時間枠：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
|
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Change from Baseline in hip joint function as measured by Modified Harris Hip Score (mHHS)
時間枠：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
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Change from Baseline in health-related quality of life as measured by the 12-Item Short Form Health Survey (SF-12)
時間枠：Baseline and Month 12
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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
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Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：From baseline up to Month 12
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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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。