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Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery

20. September 2021 aktualisiert von: Ryan McMillen, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery: A Prospective Analysis

The primary objective of this study is to determine whether immediate weight-bearing following foot and ankle surgery provides similar or superior results to the traditional non-weight-bearing post-operative course, while reducing the disuse atrophy and length of rehabilitation necessary to recover during the transition to weight-bearing following an extended course of non-weight-bearing. This will be done by way of clinical follow-up, serial radiographs and/or other appropriate imaging modalities, and patient reported outcomes by way of AOFAS and SF-36 surveys.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The study is a randomized 1:1, controlled trial, prospective in nature, where participants undergoing foot and ankle surgery will be randomly placed into one of two groups; an immediate weight-bearing group or a non-weight-bearing group. The patients will be randomly placed into the study group and control group if they meet all eligibility criteria.

This study will be conducted at 5 investigative clinic sites; West Penn Hospital, Forbes Regional Hospital, Jefferson Regional Hospital, Bethel Park Surgery Center, and Monroeville Surgery. Recruitment will stop when a minimum of 230 subjects are consented.

The study duration will require 7 visits to the clinic plus a surgery day therefore will require a pre-surgical visit/screening, surgery procedural day and six outpatient post-operative visits to the clinics. The entire follow up period will occur over 2 years.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

5

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Pennsylvania
      • Clairton, Pennsylvania, Vereinigte Staaten, 15025
        • Steel Valley Orthopaedic and Sports Medicine
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15224
        • The Foot & Ankle Institute/Western Pennsylvania Hospital

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

18 Jahre bis 89 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  1. Males or females age 18 to 89 years
  2. Undergoing foot and ankle surgery
  3. Must be able to read and understand English and consent for themselves

Exclusion Criteria:

  1. Diagnosed peripheral neuropathy
  2. Diagnosed peripheral vascular disease
  3. Documented infection to the surgical extremity
  4. Previous surgery to the surgical limb
  5. Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease which would predispose patients to poor healing and/or non-union
  6. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

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: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: Immediate protected weight-bearing
Sonstiges: Weight Bearing
Immediate protected weight bearing in a CAM walking boot following foot & ankle surgery
Andere Namen:
  • Frühe Gewichtsbelastung
Sonstiges: Traditional non weight bearing
Strict non-weight-bearing
Sonstiges: Strict non-weight bearing
Strict non weight bearing for 6 weeks following foot & ankle surgery
Andere Namen:
  • Non-weight bearing

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
Zeitfenster: Both Arms: Screening
American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy
Both Arms: Screening
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
Zeitfenster: Both Arms: Post-operative 6-8 weeks
American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy
Both Arms: Post-operative 6-8 weeks
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
Zeitfenster: Both Arms: Post-operative 3 month
American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy
Both Arms: Post-operative 3 month
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
Zeitfenster: Both Arms: Post-operative 12 month
American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy
Both Arms: Post-operative 12 month
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
Zeitfenster: Both Arms: Post-operative 24 month
American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy
Both Arms: Post-operative 24 month
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
Zeitfenster: Both Arms: Screening
36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy
Both Arms: Screening
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
Zeitfenster: Both Arms: Post-operative 6-8 weeks
36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy
Both Arms: Post-operative 6-8 weeks
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
Zeitfenster: Both Arms: Post-operative 3 month
36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy
Both Arms: Post-operative 3 month
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
Zeitfenster: Both Arms: Post-operative 12 month
36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy
Both Arms: Post-operative 12 month
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
Zeitfenster: Both Arms: Post-operative 24 month
36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy
Both Arms: Post-operative 24 month

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Zeitfenster: Both arms: Screening
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Screening
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Zeitfenster: Both arms: Post-operative 2-3 weeks
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Post-operative 2-3 weeks
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Zeitfenster: Both arms: Post-operative 6-8 weeks
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Post-operative 6-8 weeks
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Zeitfenster: Both arms: Post-operative 3 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Post-operative 3 month
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Zeitfenster: Both arms: Post-operative 6 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Post-operative 6 month
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Zeitfenster: Both arms: Post-operative 12 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Post-operative 12 month
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Zeitfenster: Both arms: Post-operative 24 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Post-operative 24 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Zeitfenster: Both arms: Screening
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Screening
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Zeitfenster: Both arms: Post-operative 2-3 weeks
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Post-operative 2-3 weeks
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Zeitfenster: Both arms: Post-operative 6-8 weeks
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Post-operative 6-8 weeks
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Zeitfenster: Both arms: Post-operative 3 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Post-operative 3 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Zeitfenster: Both arms: Post-operative 6 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Post-operative 6 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Zeitfenster: Both arms: Post-operative 12 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Post-operative 12 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Zeitfenster: Both arms: Post-operative 24 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Post-operative 24 month

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Ermittler

  • Hauptermittler: Ryan L. McMillen, DPM, FACFAS, Steel Valley Orthopaedic & Sports Medicine

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)

29. Juli 2019

Primärer Abschluss (Tatsächlich)

15. Juli 2021

Studienabschluss (Tatsächlich)

15. Juli 2021

Studienanmeldedaten

Zuerst eingereicht

22. Mai 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Juni 2019

Zuerst gepostet (Tatsächlich)

25. Juni 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. September 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. September 2021

Zuletzt verifiziert

1. September 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 2019-124JH

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Principal Investigator and Co-Investigators are part of the Allegheny Health Network and will have complete access to all data for the purpose of publication at study completion. No other outside entities are involved in this research study.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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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