- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03260699
Economic and Functional Impact of Peri-Operative Bracing for Primary Total Knee Arthroplasty (TKA)
24. September 2019 aktualisiert von: Carlos Higuera-Rueda, The Cleveland Clinic
To Determine the Economic and Functional Impact of Peri-Operative Extension Assist Pneumatic Bracing for Primary Total Knee Arthroplasty (TKA) Non-Inferiority Trial
While bracing has been shown to be beneficial for patients with osteoarthritis (OA) in terms of function and strength, whether these unloader braces are also similarly beneficial after total knee arthroplasty (TKA) surgery needs to be examined.
Therefore the investigators questioned whether wearing a brace that has previously been shown to increase strength and function in OA patients can also increase strength and function in patients after TKA.
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
9
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Ohio
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Cleveland, Ohio, Vereinigte Staaten, 44195
- Cleveland Clinic
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
50 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
Age: 50 years or older
Exclusion Criteria:
- BMI > 40
- Radiographic deformity of greater than 10 degrees
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Kein Eingriff: Control group
Subjects will receive two out-patient physical therapy (PT) visits per week for 2 weeks, followed by additional PT visits at clinician's discretion after TKA.
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Experimental: Bracing group
Subjects will be fitted with the Ongoing Care Solutions, Inc (OCSI) Rehabilitator brace prior to surgery.
This brace will be worn for 6 weeks before surgery.
The brace will be worn again after surgery ~10 days after surgery or when staples are removed until the end of the study.
Participants will also have two PT visits per week for 2 weeks, followed by additional PT visits at clinician's discretion.
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Guardian Brace features the innovative Rehabilitator™ line of gait correcting, leg strengthening braces.
Rehabilitator™ Knee Braces are clinically proven to reduce UNBRACED pain, strengthen the affected leg, and significantly improve function after only 90 days of brace wear.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Physical Therapy Visits
Zeitfenster: Total number of visits from date of surgery to 12 weeks after surgery
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Investigators will monitor the total number of physical therapy visits that was necessary to return to normal function between the control and bracing group and how it relates to overall cost.
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Total number of visits from date of surgery to 12 weeks after surgery
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Visual Analog Scale (VAS) for Pain (0-10 Scale)
Zeitfenster: Change from baseline to 12 weeks after surgery
|
Visual Analog Scale is a a pain scale assessment instrument that has been widely used to allow adult patients to report their pain level in musculoskeletal research studies.
It is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 two ends representing the extremes of measurements with 0 point representing no pain and 10 representing the worst pain a patient may have had.
Therefore, starting from zero point, increasing numbers demonstrate worse pain.
Patient can pick a point on the scale that they believe represent their pain level at a given moment.
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Change from baseline to 12 weeks after surgery
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Timed up and go Test (Timed Measurement)
Zeitfenster: Change from baseline to 12 weeks after surgery
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Used to assess a person's mobility and balance.
It is measured in time units (seconds or minutes) using a stopwatch by a study personnel.
To perform, the patient sits back in a standard arm chair and a line 3 meters, or 10 feet away on the floor is identified.
At the investigator mark, the stopwatch is started and the patient is asked to stand up from chair, walk to the end of the line and come back to his chair at normal pace.
The results is the time in seconds needed for the patient to perform the test (getting up from chair and coming back to it as timed by the investigator's stopwatch)
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Change from baseline to 12 weeks after surgery
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Timed Stair Climb (Timed Measurement Over Fixed Distance)
Zeitfenster: Change from baseline to 12 weeks after surgery
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Used to assess a person's mobility and balance
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Change from baseline to 12 weeks after surgery
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One-leg Stance Time (Timed Measurement)
Zeitfenster: Change from baseline to 12 weeks after surgery
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Used to assess a person's balance.
Performed with eyes open and arms on hips.
The patient is asked to stand unassisted on one leg and is timed in seconds (using stopwatch) from the time one foot is flexed off the floor to the time when it touches the ground or the standing leg or an arm leaves the hips.
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Change from baseline to 12 weeks after surgery
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6 Minute Walk Test (Distance Measurement)
Zeitfenster: Change from baseline to 12 weeks after surgery
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Used to assess a person's endurance and aerobic capacity.
The score of the test is distance a patient walks in 6 minutes.
Longer distances walked by the patient in 6 minutes correlates with better performance.
Distance is measured using distance measuring wheel.
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Change from baseline to 12 weeks after surgery
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Knee Society Score Questionnaire
Zeitfenster: Change from baseline to 12 weeks after surgery
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Clinical outcome questionnaire developed by the consensus of the Knee Society.
It comprises, a "Knee score" and a "Functional score."
The Knee score assesses pain, stability, and range of motion.
A maximum score of 100 is achieved by a painless, well-aligned knee with 125° range of motion, with neither anteroposterior nor mediolateral instability.
Deductions are made for flexion contracture, extension lag, and malalignment.
The Functional score assesses walking distance and stair climbing.
A maximum score of 100 is assigned to individuals who can walk unlimited distances and can climb up and down stairs normally.
Deductions are made for use of a walking stick or crutches.
Therefore, higher scores correlate with better function and outcome.
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Change from baseline to 12 weeks after surgery
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Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.) Questionnaires
Zeitfenster: Change from baseline to 12 weeks after surgery
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Clinical outcome questionnaire that measure joint-specific pain and physical function.
It has seven questions that focus on three categories: joint pain, stiffness, and function, in daily living.
Raw scores are added up (range 0-28) and converted to an interval score (0-100) using an interval table.
The interval score represents a patients total joint disability where 0 corresponds to total joint disability and 100 perfect joint health.
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Change from baseline to 12 weeks after surgery
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Hospital for Special Surgery (HSS) Score (0-100 Scale)
Zeitfenster: Change from baseline to 12 weeks after surgery
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Clinical outcome assessment tool.
It is based on a total of 100 points.
The score is divided into seven categories, which include pain, function, range of motion, muscle strength, flexion deformity, instability, and subtractions.
The knee is initially given a score of 0, and additions or subtractions are made according to specific criteria.
The higher the score, the better the outcome.
Approximately 50% of the score is based on a patient interview and the remaining on physical exam.
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Change from baseline to 12 weeks after surgery
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Type of Pain Medication Used
Zeitfenster: Change from baseline to 12 weeks after surgery
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Investigators will monitor the medical record for types of pain medications used.
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Change from baseline to 12 weeks after surgery
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Amount of Pain Medication Used
Zeitfenster: Change from baseline to 12 weeks after surgery
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Investigators will monitor the medical record for the amount of pain medication used
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Change from baseline to 12 weeks after surgery
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienstuhl: Spindler Kurt, MD, Department Chair
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
5. Oktober 2017
Primärer Abschluss (Tatsächlich)
1. Januar 2018
Studienabschluss (Tatsächlich)
1. Januar 2018
Studienanmeldedaten
Zuerst eingereicht
10. Juli 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
21. August 2017
Zuerst gepostet (Tatsächlich)
24. August 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
9. Oktober 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
24. September 2019
Zuletzt verifiziert
1. September 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SHB-OCSI007
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Ja
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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