Långtidsuppföljning av Integra® Cadence™ Total Ankel System i primär ankelledsersättning
17 juni 2026 uppdaterad av: Smith & Nephew, Inc.
Denna studie kommer att utvärdera de långsiktiga prestanda- och säkerhetsdata för Cadence™ Total Ankle System (CTAS) när det används för primär artroplastik hos patienter med primär artrit (t.
degenerativ sjukdom), sekundär artrit (t.ex.
posttraumatisk, avaskulär nekros, om minst 2/3 av talus bevaras), och systemisk artrit i fotleden (t.ex.
reumatoid artrit, hemokromatos)
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
65
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ghent, Belgien, 9000
- Universitair Ziekenhuis Gent
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Woluwe-St-Lambert, Belgien, B-1200
- Foot and Ankle Institute
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Tours, Frankrike, 37044
- CHRU Tours
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Toronto, Kanada, M5C 1R6
- St. Michael's Hospital
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Barcelona, Spanien, 08024
- Clinica Nostra Senhora del Remei
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Carlisle, Storbritannien, CA2 7HY
- North Cumbria University Hospitals
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patient med fotledsartrit som kräver total fotledsbyte
Beskrivning
Inklusionskriterier:
Ämnen kommer att inkluderas om han/hon:
- Kvalificerar för primär total fotledsersättning (TAR) per kirurg och har en diagnos på något av följande: primär artrit (t.ex. degenerativ sjukdom), sekundär artrit (t.ex. posttraumatisk, avaskulär nekros, om minst 2/3 av talus bevaras), eller systemisk artrit i fotleden (t.ex. reumatoid artrit, hemokromatos).
- Är lämplig för TAR med Cadence™ Total Ankel System enligt studiekirurgen baserat på produktindikationen och med hänsyn till deformitet, stabilitet, benkvalitet, mjukvävnadshölje och neurovaskulär status.
- Är villig och kapabel att genomföra schemalagda uppföljningsbesök, utvärderingar och frågeformulär enligt beskrivningen i det informerade samtycket (eller informationsbrevet och formuläret för tillstånd för dataöverföring, i tillämpliga fall).
Exklusions kriterier:
Försökspersoner kommer att exkluderas från studien om han/hon:
- Är sjukligt fet (definierad av ett Body Mass Index (BMI) > 40 eller BMI på 35 - 40 med betydande medicinska problem orsakade av eller förvärrat av sin vikt).
- Har ett av följande tillstånd som kan äventyra den drabbade extremiteten: fotledsartrodes med malleolär exeres, allvarlig neurologisk (Charcots artropati) eller vaskulär sjukdom, förlust av muskulatur eller neuromuskulär kompromiss.
- Har en aktiv lokal/systemisk infektion som kan påverka protesleden eller har nyligen haft infektion.
- Har ett tillstånd som kan försämra korrekt sårläkning (t.ex. dåligt mjukdelshölje).
- Har en metabolisk störning eller sjukdom som kan äventyra benkvaliteten (t. arthrogryposis etc.), fysiologiska eller anatomiska anomalier och/eller malignitet/lokala bentumörer.
- Har otillräcklig neuromuskulär status (t.ex. tidigare förlamning, svår neuropati).
- Har en känd känslighet eller allergisk reaktion mot ett eller flera av de implanterade materialen.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Integra Cadence Total Ankel System
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Primary Ankle Arthroplasty
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Implant Survivorship at 2 Years
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Implant Survivorship at 5 Years and 10 Years
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 september 2017
Primärt slutförande (Faktisk)
6 september 2023
Avslutad studie (Faktisk)
6 september 2023
Studieregistreringsdatum
Först inskickad
8 augusti 2017
Först inskickad som uppfyllde QC-kriterierna
8 augusti 2017
Första postat (Faktisk)
11 augusti 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juni 2026
Senast verifierad
1 december 2024
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- T-CTAS-002
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Kliniska prövningar på Reumatoid artrit
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Novartis PharmaceuticalsRekryteringRheumatoid artrit (RA) och Sjögrens sjukdom (SJD)Spanien, Frankrike, Tyskland, Singapore