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
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Todellinen)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Pennsylvania
-
Clairton, Pennsylvania, Yhdysvallat, 15025
- Steel Valley Orthopaedic and Sports Medicine
-
Pittsburgh, Pennsylvania, Yhdysvallat, 15224
- The Foot & Ankle Institute/Western Pennsylvania Hospital
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
|
Muut: Immediate protected weight-bearing
|
Immediate protected weight bearing in a CAM walking boot following foot & ankle surgery
Muut nimet:
|
|
Muut: Traditional non weight bearing
Strict non-weight-bearing
|
Strict non weight bearing for 6 weeks following foot & ankle surgery
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Tutkijat
Tutkijat
- Päätutkija: Ryan L. McMillen, DPM, FACFAS, Steel Valley Orthopaedic & Sports Medicine
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Ensisijainen valmistuminen
Opintojen valmistuminen (Todellinen)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- 2019-124JH
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Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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