Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

20. september 2021 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Fot- og ankelkirurgi

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

Fase

Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Pennsylvania
  - Clairton, Pennsylvania, Forente stater, 15025
    - Steel Valley Orthopaedic and Sports Medicine
  - Pittsburgh, Pennsylvania, Forente stater, 15224
    - The Foot & Ankle Institute/Western Pennsylvania Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 89 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Ingen (Open Label)

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Annen: Immediate protected weight-bearing	Annen: Weight Bearing Immediate protected weight bearing in a CAM walking boot following foot & ankle surgery Andre navn: Tidlig vektbæring
Annen: Traditional non weight bearing Strict non-weight-bearing	Annen: Strict non-weight bearing Strict non weight bearing for 6 weeks following foot & ankle surgery Andre navn: Non-weight bearing

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

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

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. juli 2019

Primær fullføring (Faktiske)

15. juli 2021

Studiet fullført (Faktiske)

15. juli 2021

Datoer for studieregistrering

Først innsendt

22. mai 2019

Først innsendt som oppfylte QC-kriteriene

21. juni 2019

Først lagt ut (Faktiske)

25. juni 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. september 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. september 2021

Sist bekreftet

1. september 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

2019-124JH

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Weight Bearing

University of Pittsburgh

Fullført

Vektbærende status Post-hofteartroskopi

Acetabulær labral tåre | Hip Impingement Syndrome

Forente stater
Hvidovre University Hospital
Zimmer Biomet

Ukjent

NexGen Gender Fixed Bearing Knee Versus NexGen Legacy Knee Posterior Stabilized (LPS) - Flex Fixed Bearing Knee: En studie som sammenligner to forskjellige kneproteser

Total kneartroplastikk

Danmark
University of California, San Francisco

Tilbaketrukket

Laparoscopic Sleeve Gastrectomy Plus Weight Watchers vs Weight Watchers Alene i undertjente minoritetskvinner

Sykelig fedme

Forente stater
DePuy International

Avsluttet

PFC Sigma Fixed and Mobile Knee Study

Artrose, kne

Storbritannia
Zimmer Biomet

Fullført

Prospektiv multisenter postgodkjenningsstudie av LPS-Flex Mobile Bearing Knee

Artrose | Traumatisk leddgikt | Avaskulær nekrose av femoralkondylen | Moderat Varus | Valgus | Fleksjonsdeformiteter

Forente stater
University of Rochester

Fullført

Deaf Weight Wise 2.0: En sunn livsstilsintervensjon med døve voksne som er overvektige eller overvektige (DWW2)

Overvekt | Overvektig

Forente stater
University of Pennsylvania
WW International Inc

Fullført

Nevrokognitive fordeler med et vektkontrollprogram

Overvekt og fedme

Forente stater
University of Rochester

Fullført

Studie av en sunn livsstilsintervensjon for døve voksne som er overvektige eller overvektige (DWW)

Overvekt | Overvektig

Forente stater
University of North Carolina, Chapel Hill
Weight Watchers International

Fullført

Evaluering av et kommersielt program for vekttap og helseresultater

Overvekt og fedme

Forente stater
The Cleveland Clinic
Abdominal Core Health Quality Collaborative

Fullført

Kortsiktige resultater av tungvekt versus middels vekt syntetisk netting i en retrospektiv kohort av reparasjoner av rent og kontaminert retromuskulær ventral brokk

Brokk, Ventral | Insisjonell brokk

Forente stater

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