一次足関節置換術における Integra® Cadence™ Total Ankle System の長期フォローアップ
2026年6月17日 更新者：Smith & Nephew, Inc.
この研究では、原発性関節炎患者（例：
変性疾患）、二次性関節炎（例：
距骨の少なくとも 2/3 が保存されている場合、心的外傷後、無血管性壊死)、および足関節の全身性関節炎 (例:
関節リウマチ、ヘモクロマトーシス）
調査の概要
研究の種類
観察的
入学 (実際)
65
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Carlisle、イギリス、CA2 7HY
- North Cumbria University Hospitals
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Toronto、カナダ、M5C 1R6
- St. Michael's Hospital
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Barcelona、スペイン、08024
- Clinica Nostra Senhora del Remei
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Tours、フランス、37044
- CHRU Tours
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Ghent、ベルギー、9000
- Universitair Ziekenhuis Gent
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Woluwe-St-Lambert、ベルギー、B-1200
- Foot and Ankle Institute
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
足首全置換術を必要とする足首関節炎の患者
説明
包含基準:
次の場合に被験者が含まれます。
- 外科医による一次足関節全置換術 (TAR) の資格があり、次のいずれかの診断を受けている: 変性疾患）、二次性関節炎（例： 距骨の少なくとも 2/3 が保存されている場合、心的外傷後、無血管性壊死)、または足関節の全身性関節炎 (例: 関節リウマチ、ヘモクロマトーシス）。
- 製品の適応症に基づき、変形、安定性、骨の質、軟組織エンベロープ、および神経血管の状態を考慮した上で、研究外科医による Cadence™ Total Ankle System による TAR に適しています。
- -インフォームドコンセント（または情報レターとデータ転送承認フォーム、該当する場合）に記載されているように、予定されたフォローアップ訪問、評価、およびアンケートを完了する意思があり、完了することができます。
除外基準:
次の場合、被験者は研究から除外されます。
- 病的肥満である（ボディマス指数（BMI）> 40または35～40のBMIで定義され、体重が原因または体重によって悪化する重大な医学的問題がある）。
- 患肢を危険にさらす可能性のある次の状態のいずれかを持っています: くるぶし運動を伴う足首関節固定術、重度の神経学的 (シャルコー関節症) または血管疾患、筋肉組織の喪失または神経筋障害。
- -人工関節に影響を与える可能性のある活動的な局所/全身感染症があるか、最近の感染歴があります。
- 適切な創傷治癒を損なう可能性のある状態を持っている (例: 軟部組織エンベロープが悪い)。
- 骨の質を損なう可能性のある代謝障害または疾患がある（例： 関節拘縮など）、生理学的または解剖学的異常、および/または悪性腫瘍/局所骨腫瘍。
- 神経筋の状態が不十分である（例えば、以前の麻痺、重度の神経障害）。
- 1 つまたは複数の埋め込み材料に対して既知の過敏症またはアレルギー反応がある。
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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Integra Cadence トータルアンクルシステム
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Primary Ankle Arthroplasty
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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 |
|---|---|---|
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Implant Survivorship at 2 Years
時間枠：2 years
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Implant survivorship determined by the percentage of participants with survival of the device.
Successful device survival was defined as absence of device removal or revision.
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2 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Implant Survivorship at 5 Years and 10 Years
時間枠：5 years and 10 years
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Implant survivorship at 5 years and 10 years was determined by the percentage of participants with device survival.
Survivorship was measured using a Kaplan-Meier survival estimate with survival defined as absence of device removal or revision.
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5 years and 10 years
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Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility
時間枠：Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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The PROMIS - Physical Function and Mobility score consisted of 15 components on a 5-point Likert scale.
Responses were combined to produce a score that ranged from 0 to 100 where higher values represented higher mobility (i.e., a higher score was a better outcome).
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Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Subscale
時間枠：Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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The Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Subscale scored 21 components on a 5-point Likert scale.
Score totals ranged from 0 to 84 and were transformed to percentage scores with 100 representing no dysfunction (i.e., a higher score was a better outcome).
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Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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Visual Analogue Scale (VAS) Pain Score: Resting
時間枠：Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years
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A Visual Analogue Scale (VAS) assessment was used to rate ankle pain while resting.
The participant would indicate the level of pain by placing a vertical mark on a 100mm scale.
Scores ranged from 0 to 100 with higher scores indicating a higher level of pain (i.e., a higher score was a worse outcome).
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Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years
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Visual Analogue Scale (VAS) Pain Score: Activity
時間枠：Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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A Visual Analogue Scale (VAS) assessment was used to rate ankle pain while during activity.
The participant would indicate the level of pain by placing a vertical mark on a 100mm scale.
Scores ranged from 0 to 100 with higher scores indicating a higher level of pain (i.e., a higher score was a worse outcome).
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Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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Short Form-36 Version 2 Health Survey (SF-36v2): Physical Functioning
時間枠：Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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The SF-36v2 Health Survey is composed of 36 questions across 8 domains.
The Physical Functioning domain focused on limitations in daily activities like running, climbing stairs, bending, or walking.
Scores ranged from 0 to 100 with lower scores indicating greater physical disability (i.e., a higher score was a better outcome).
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Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Physical Health
時間枠：Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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The SF-36v2 Health Survey is composed of 36 questions across 8 domains.
The Role Limitations Due to Physical Health domain focused on limitations in work or other regular daily activities as a result of their physical health.
Scores ranged from 0 to 100 with lower scores indicating greater limitation (i.e., a higher score was a better outcome).
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Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Emotional Problems
時間枠：Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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The SF-36v2 Health Survey is composed of 36 questions across 8 domains.
The Role Limitations Due to Emotional Problems domain focused on limitations in work or other regular daily activities as a result of any emotional problems such as feeling depressed or anxious.
Scores ranged from 0 to 100 with lower scores indicating greater limitation (i.e., a higher score was a better outcome).
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Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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Short Form-36 Version 2 Health Survey (SF-36v2): Energy/Fatigue
時間枠：Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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The SF-36v2 Health Survey is composed of 36 questions across 8 domains.
The Energy/Fatigue domain focused on feelings of energy, tiredness, and being worn out over the past four weeks.
Scores ranged from 0 to 100 with lower scores indicating less energy and more fatigue (i.e., a higher score was a better outcome).
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Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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Short Form-36 Version 2 Health Survey (SF-36v2): Emotional Well-being
時間枠：Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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The SF-36v2 Health Survey is composed of 36 questions across 8 domains.
The Emotional Well-being domain focused on feelings of their mental health over the past four weeks.
Scores ranged from 0 to 100 with lower scores indicating poor emotional well-being (i.e., a higher score was a better outcome).
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Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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Short Form-36 Version 2 Health Survey (SF-36v2): Social Functioning
時間枠：Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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The SF-36v2 Health Survey is composed of 36 questions across 8 domains.
The Social Functioning domain focused on how physical health or emotional problems interfered with their social activities (like visiting with friends, relatives, etc.).
Scores ranged from 0 to 100 with lower scores indicating greater disfunction (i.e., a higher score was a better outcome).
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Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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Short Form-36 Version 2 Health Survey (SF-36v2): Pain
時間枠：Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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The SF-36v2 Health Survey is composed of 36 questions across 8 domains.
The Pain domain focused on how much pain affected daily activities over the last four weeks.
Scores ranged from 0 to 100 with lower scores indicating more pain (i.e., a higher score was a better outcome).
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Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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Short Form-36 Version 2 Health Survey (SF-36v2): General Health
時間枠：Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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The SF-36v2 Health Survey is composed of 36 questions across 8 domains.
The General Health domain focused on perception of overall health and health change over time.
Scores ranged from 0 to 100 with lower scores indicating worse health (i.e., a higher score was a better outcome).
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Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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Short Form-36 Version 2 Health Survey (SF-36v2): Physical Component Score
時間枠：Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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The SF-36v2 Health Survey is composed of 36 questions across 8 domains.
The Physical Component score combined scores from the Physical Functioning, Role Limitations Due to Physical Health, Pain, and General Health domains.
Scores ranged from 0 to 100 with lower scores indicating worse physical health (i.e., a higher score was a better outcome).
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Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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Short Form-36 Version 2 Health Survey (SF-36v2): Mental Component Score
時間枠：Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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The SF-36v2 Health Survey is composed of 36 questions across 8 domains.
The Physical Component score combined scores from the Role Limitations Due to Emotional Problems, Energy/Fatigue, Emotional Well-being, and Social Functioning domains.
Scores ranged from 0 to 100 with lower scores indicating worse mental health (i.e., a higher score was a better outcome).
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Baseline, 3 months, 6 months, 1 year, 2 years, 5 years
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Radiographic Success
時間枠：6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years
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The number of participants with radiographic success were categorized as either 'Fail' or 'Success'. Success was defined as absence of implant radiolucency, subsidence, tilting, and/or migration with failure specifically defined as occurring if:
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6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years
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Radiographic Assessment: Ankle Dorsiflexion and Plantarflexion Range of Motion
時間枠：Baseline, 1 year, 2 years
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Range of motion measurements for ankle dorsiflexion and ankle plantarflexion in degrees were derived from radiographs in positions of maximum plantarflexion and dorsiflexion.
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Baseline, 1 year, 2 years
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Radiographic Assessment: Tibiotalar Range of Motion
時間枠：Baseline, 1 year, 2 years
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Range of motion measurements were derived from radiographs in positions of maximum plantarflexion and dorsiflexion.
Tibiotalar range of motion in degrees was calculated as the difference between the ankle dorsiflexion and ankle plantarflexion angles.
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Baseline, 1 year, 2 years
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年9月18日
一次修了 (実際)
2023年9月6日
研究の完了 (実際)
2023年9月6日
試験登録日
最初に提出
2017年8月8日
QC基準を満たした最初の提出物
2017年8月8日
最初の投稿 (実際)
2017年8月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月22日
QC基準を満たした最後の更新が送信されました
2026年6月17日
最終確認日
2024年12月1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。