Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

20 september 2021 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

5

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

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 till 89 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Immediate protected weight-bearing
Övrig: Weight Bearing
Immediate protected weight bearing in a CAM walking boot following foot & ankle surgery
Andra namn:
  • Tidig viktbärande
Övrig: Traditional non weight bearing
Strict non-weight-bearing
Övrig: Strict non-weight bearing
Strict non weight bearing for 6 weeks following foot & ankle surgery
Andra namn:
  • Non-weight bearing

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

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

Utredare

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

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)

29 juli 2019

Primärt slutförande (Faktisk)

15 juli 2021

Avslutad studie (Faktisk)

15 juli 2021

Studieregistreringsdatum

Först inskickad

22 maj 2019

Först inskickad som uppfyllde QC-kriterierna

21 juni 2019

Första postat (Faktisk)

25 juni 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 september 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 september 2021

Senast verifierad

1 september 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 2019-124JH

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Weight Bearing

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Sweden

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

Prenumerera