Carpal Tunnel Release Using Ultrasound (CiTRUS)
16. august 2022 oppdatert av: Sonex Health, Inc.
Carpal Tunnel Release Using Ultrasound Patient Experience Registry
The goal of the Carpal Tunnel Release Using Ultrasound registry (CiTRUS Registry) is to collect experience information from patients scheduled to undergo carpal tunnel release surgery with either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without US guidance.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The CiTRUS registry is an observational study designed to better understand the overall patient experience following a carpal tunnel release surgery using either the SX-One MicroKnife with ultrasound guidance or the traditional mini-open technique without ultrasound guidance.
The determination of which surgical technique to uses will be determined by the treating physician and the patient.
The patient registry outcomes are intended to help direct future clinical care, educate patients with carpal tunnel syndrome, and design future research.
Studietype
Observasjonsmessig
Registrering (Faktiske)
411
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Minnesota
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Eagan, Minnesota, Forente stater, 55121
- Sonex Health, Inc.
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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 og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients scheduled to undergo carpal tunnel release surgery using either the SX-One MicroKnife® with ultrasound (US) guidance or the traditional mini-open technique without ultrasound guidance.
Beskrivelse
Inclusion Criteria:
- Scheduled to undergo carpal tunnel release surgery on the right and/or left wrist using either the SX-One MicroKnife with US guidance or the traditional mini-open technique without US guidance
- 18 years of age or older
- Agree to complete questionnaires over a 12-month period
- Valid mobile phone number and email address to receive and answer questions
Exclusion Criteria:
• Age less than 18 years
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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SX-One MicroKnife with ultrasound guidance
Carpal Tunnel Release using the SX-One MicroKnife with ultrasound guidance
|
Carpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms.
The carpal tunnel release surgery will be performed using the SX-One MicroKnife with ultrasound guidance.
Carpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms.
The carpal tunnel release surgery will be performed using the traditional mini-open technique without ultrasound guidance.
|
|
Traditional mini-open technique without ultrasound guidance
Carpal Tunnel Release using the traditional mini-open technique without ultrasound guidance
|
Carpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms.
The carpal tunnel release surgery will be performed using the SX-One MicroKnife with ultrasound guidance.
Carpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms.
The carpal tunnel release surgery will be performed using the traditional mini-open technique without ultrasound guidance.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline Quick Form of the Disabilities of the Shoulder and Hand scores at 12 months
Tidsramme: 12 months
|
To assess the overall patient experience following carpal tunnel release using either the SX-One MicroKnife® with ultrasound (US) guidance or the traditional mini-open technique without ultrasound guidance patients will complete the Quick Form of the Disabilities of the Shoulder and Hand scale.
The Quick Form of the Disabilities of the Shoulder and Hand scale consists of 11 items scored 1-5 with lower scores indicating less symptoms or better function.
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12 months
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Change from baseline Boston Carpal Tunnel Questionnaire scores at 12 months
Tidsramme: 12 months
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To assess the overall patient experience following carpal tunnel release using either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without ultrasound guidance patients will complete the Boston Carpal Tunnel Questionnaire at 12 months.
The Boston Carpal Tunnel Questionnaire consists of two subscales: symptom severity (11 items scored 1-5) and functional status (8 items scored 1-5) with lower scores indicating less symptoms or better function.
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12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient reported time to return to activities
Tidsramme: Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months
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Patient reported time to return to normal activities as measured in days.
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Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Patient reported satisfaction following carpal tunnel release
Tidsramme: 2 weeks, 1,3,6 and 12 months
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Patient reported satisfaction with the carpal tunnel release procedure on a 1-5 scale with higher numbers indicating greater satisfaction.
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2 weeks, 1,3,6 and 12 months
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Patient reported symptom improvement following carpal tunnel release
Tidsramme: 2 weeks, 1,3,6 and 12 months
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Patient reported improvement in symptoms following carpal tunnel release, reported on a 1-5 scale with higher numbers indicating more symptom improvement.
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2 weeks, 1,3,6 and 12 months
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Pain reported pain on numerical pain rating scale
Tidsramme: Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months
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Patient reported pain following carpal tunnel release, reported on an 11-point (0-10) numerical pain rating scale with higher numbers indicating more pain.
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Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Jay Smith, MD, Sonex Health, Inc.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Kamel SI, Freid B, Pomeranz C, Halpern EJ, Nazarian LN. Minimally Invasive Ultrasound-Guided Carpal Tunnel Release Improves Long-Term Clinical Outcomes in Carpal Tunnel Syndrome. AJR Am J Roentgenol. 2021 Aug;217(2):460-468. doi: 10.2214/AJR.20.24383. Epub 2020 Sep 2.
- Chappell CD, Beckman JP, Baird BC, Takke AV. Ultrasound (US) Changes in the Median Nerve Cross-Sectional Area After Microinvasive US-Guided Carpal Tunnel Release. J Ultrasound Med. 2020 Apr;39(4):693-702. doi: 10.1002/jum.15146. Epub 2019 Oct 29.
- Joseph AE, Leiby BM, Beckman JP. Clinical Results of Ultrasound-Guided Carpal Tunnel Release Performed by a Primary Care Sports Medicine Physician. J Ultrasound Med. 2020 Mar;39(3):441-452. doi: 10.1002/jum.15120. Epub 2019 Aug 26.
- Henning PT, Yang L, Awan T, Lueders D, Pourcho AM. Minimally Invasive Ultrasound-Guided Carpal Tunnel Release: Preliminary Clinical Results. J Ultrasound Med. 2018 Nov;37(11):2699-2706. doi: 10.1002/jum.14618. Epub 2018 Apr 2.
- Latzka EW, Henning PT, Pourcho AM. Sonographic Changes After Ultrasound-Guided Release of the Transverse Carpal Ligament: A Case Report. PM R. 2018 Oct;10(10):1125-1129. doi: 10.1016/j.pmrj.2018.02.018. Epub 2018 Mar 6.
- Henning T, Lueders D, Chang K, Yang L. Ultrasound-Guided Carpal Tunnel Release Using Dynamic Expansion of the Transverse Safe Zone in a Patient With Postpolio Syndrome: A Case Report. PM R. 2018 Oct;10(10):1115-1118. doi: 10.1016/j.pmrj.2018.02.016. Epub 2018 Mar 6.
- Leiby BM, Beckman JP, Joseph AE. Long-term Clinical Results of Carpal Tunnel Release Using Ultrasound Guidance. Hand (N Y). 2022 Nov;17(6):1074-1081. doi: 10.1177/1558944720988080. Epub 2021 Jan 29.
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)
2. juli 2021
Primær fullføring (Faktiske)
1. august 2022
Studiet fullført (Faktiske)
15. august 2022
Datoer for studieregistrering
Først innsendt
26. august 2021
Først innsendt som oppfylte QC-kriteriene
26. august 2021
Først lagt ut (Faktiske)
1. september 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. august 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. august 2022
Sist bekreftet
1. august 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CL002
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