Total Knee Arthroplasty: Functional and Clinical Outcomes
28. dubna 2017 aktualizováno: Duke University
Clinical and Functional Outcomes Following Total Knee Replacement Using Two Different Implants
The purpose of this study is to assess the differences in functional and patient reported outcomes between total knee replacement (TKA) implants.
In addition, this work will examine the correlation between functional assessments and patient reported outcomes following surgery.
All subjects will complete assessments preoperatively, 4-6 weeks following TKA and then one year following TKA.
Subjects will complete a series of patient reported outcomes as well as a series of functional outcomes at each of the time points of interest.
The analysis will include a repeated measures design to determine differences between groups across time as well as correlations between the functional and patient reported outcomes.
This work will hopefully determine the importance of using objective functional outcomes following TKA as well as determining the need for patient assessments out to one year following surgery.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
The number differences in subjects analyzed from baseline to 6 weeks to 52 weeks are due to the fact that we did not use the 6 week time point in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making.
Therefore the patients used in the final analysis were those subjects who were able to and completed the assessment at pre-op and 1 year post-op which is how we get to the 20 subjects per group.
Typ studie
Intervenční
Zápis (Aktuální)
60
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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North Carolina
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Durham, North Carolina, Spojené státy, 27710
- Duke University Medical Center
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 85 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Patients requiring primary total knee replacement
- Patients willing and able to comply with the follow-up visits and evaluations
- Patients willing to sign informed consent approved by the Institutional Review Board
Exclusion Criteria:
- Patients with inflammatory arthritis
- Patients with diabetic neuropathy
- Patients unable to ambulate without the use of an assistive device prior to surgery
- Patients unable to stand in single limb stance on each foot prior to surgery.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Stryker
Subjects will be receiving the Stryker Triathlon total knee replacement
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Aktivní komparátor: Zimmer
Subjects will be receiving a Zimmer NexGen total knee replacement
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement
Časové okno: Baseline (Pre-Operative) to 6 weeks following total knee replacement
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The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid.
The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform.
The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.
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Baseline (Pre-Operative) to 6 weeks following total knee replacement
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Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement
Časové okno: Baseline (Pre-Operative) to 52 weeks following total knee replacement
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The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid.
The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform.
The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.
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Baseline (Pre-Operative) to 52 weeks following total knee replacement
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement.
Časové okno: Baseline and 52 weeks following total knee replacement
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Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.
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Baseline and 52 weeks following total knee replacement
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Walking Speed at 6 Weeks Following Total Knee Replacement.
Časové okno: 6 weeks following total knee replacement
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Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.
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6 weeks following total knee replacement
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement.
Časové okno: Baseline and 52 weeks following total knee replacement
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The UCLA activity score is a validated patient reported outcome of overall physical activity.
Results on a scale of 1 to 10, 1 is "Wholly Inactive, dependent on others, and can not leave residence" and 10 is "Regularly participates in impact sports".
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Baseline and 52 weeks following total knee replacement
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University of California, Los Angeles (UCLA) Activity Score at 6 Weeks Following Total Knee Replacement.
Časové okno: 6 weeks following total knee replacement
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The UCLA activity score is a validated patient reported outcome of overall physical activity.
Results on a scale of 1 to 10, 1 is "Wholly Inactive, dependent on others, and can not leave residence" and 10 is "Regularly participates in impact sports".
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6 weeks following total knee replacement
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Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement.
Časové okno: Baseline (Pre-Operative) and 52 weeks following total knee replacement
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The KOOS is a standardized and validated patient outcome score that assesses functional limitation in patient with knee problems.
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL).
The previous week is the time period considered when answering the questions.
Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
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Baseline (Pre-Operative) and 52 weeks following total knee replacement
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Change in Forgotten Joint Score (FJS) From 6 Weeks to 52 Weeks Following Total Knee Replacement.
Časové okno: 6 weeks and 52 weeks following total knee replacement
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The FJS is a patient reported measure of how bothersome the total joint replacement is for them, how much it affects daily activity and how much they are aware of the implant.
The FJS is a 12-question survey regarding functional outcome, pain, stability, daily living, activity and sport.
Scoring is from 0 to 4 with 0 as the best outcome; a low score means high satisfaction.
Not all questions must be answered to score, all responses are summed and the total is divided by number of completed items multiplied by 25, with the final result subtracted from 100.
The score range is from 0 to 100 with the highest score of 100 indicating the best outcome (the joint is completely "forgotten") and 0 indicating the worst outcome.
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6 weeks and 52 weeks following total knee replacement
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Knee Society Score (KSS)
Časové okno: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
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The KSS is a patient reported measure of knee function that is specific to patients who are scheduled to receive or have previously had a total knee replacement.
This outcome measures both patient reported pain and function changes from prior to surgery through recovery.
The score range is from 0 to 100.
The highest score of 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability.
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Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
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Sit to Stand Time
Časové okno: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
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The sit to stand test requires patients to stand up and sit down as many times as possible in 10 seconds from a standard arm chair.
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Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
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Timed Get up and go
Časové okno: Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
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The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.
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Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Samuel S Wellman, MD, Duke University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. února 2013
Primární dokončení (Aktuální)
26. února 2016
Dokončení studie (Aktuální)
26. února 2016
Termíny zápisu do studia
První předloženo
12. března 2013
První předloženo, které splnilo kritéria kontroly kvality
12. března 2013
První zveřejněno (Odhad)
14. března 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
2. června 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
28. dubna 2017
Naposledy ověřeno
1. dubna 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Pro00043737
- 193447 (Jiné číslo grantu/financování: Stryker)
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