- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03996707
Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery
Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery: A Prospective Analysis
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Pennsylvania
-
Clairton, Pennsylvania, Spojené státy, 15025
- Steel Valley Orthopaedic and Sports Medicine
-
Pittsburgh, Pennsylvania, Spojené státy, 15224
- The Foot & Ankle Institute/Western Pennsylvania Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Jiný: Immediate protected weight-bearing
|
Immediate protected weight bearing in a CAM walking boot following foot & ankle surgery
Ostatní jména:
|
Jiný: Traditional non weight bearing
Strict non-weight-bearing
|
Strict non weight bearing for 6 weeks following foot & ankle surgery
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Ryan L. McMillen, DPM, FACFAS, Steel Valley Orthopaedic & Sports Medicine
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 2019-124JH
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Weight Bearing
-
Damascus UniversityDokončenoOnemocnění kloubů | Komplikace artroplastiky | Artritida kolenaSyrská Arabská republika
-
DePuy InternationalUkončeno
-
Encore Medical, L.P.DokončenoOsteoartróza | Avaskulární nekróza | Posttraumatická artritida | Zánětlivá tkáňová porucha | Sekundární artritidaSpojené státy
-
Yale UniversityDokončenoHmotnost, tělo | Trauma, psychologické | ŠikanováníSpojené státy
-
Milton S. Hershey Medical CenterZatím nenabírámeOnemocnění jater | NASH - nealkoholická steatohepatitida | NASH
-
University of RochesterDokončenoObezita | NadváhaSpojené státy
-
University of AlbertaCanadian Institutes of Health Research (CIHR); Alberta Health services; Alberta...Dokončeno
-
ReShape LifesciencesAktivní, ne náborObezita, morbidníSpojené státy
-
California Polytechnic State University-San Luis...DokončenoZtráta váhySpojené státy
-
University of California, San FranciscoDokončenoKojení | Kojení, exkluzivní | Krmení, láhev | Morbidita;PerinatálníSpojené státy