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PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome

18. april 2022 opdateret af: Michael Fredericson, MD

Utilizing Platelet-Rich Plasma as an Adjuvant to Carpal Tunnel Release for Severe Carpal Tunnel Syndrome

This study assesses the potential benefit of adjuvant platelet-rich plasma (PRP) with carpal tunnel release (CTR) for patients with severe carpal tunnel syndrome (CTS). CTR is a rather common procedure performed and seems to be quite effective for those with moderate CTS, but a number of patients with severe CTS do not have quite the same response post-CTR. The investigators will recruit patients who fall into the severe CTS category and compare CTR with and without adjuvant PRP to see if PRP can improve outcomes of this common surgery.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  1. Study team recruits patients with severe CTS who meet inclusion and exclusion criteria in an outpatient hand surgery clinic. Patients will be consented by the research team if the patient agrees to participate in the research study.
  2. This will be a single blinded study, and participants will have an equal chance to be placed in either group. Participants will be randomized using permuted block randomization predetermined by our dedicated orthopedic biostatistician into two study groups: those that undergo CTR with adjuvant intra-operative PRP and those that undergo CTR without adjuvant PRP. All participants will have a pre-operative electromyography/nerve conduction study (EMG/NCS).
  3. Primary outcome measures (BCTQ and grip strength), and secondary outcome measures (PROMIS; 2 point discrimination - thumb, index finger and middle finger; key pinch; 3 finger pinch; and EMG/NCS results) will be collected and stored in REDCap at initial visit. BCTQ and PROMIS will actually be available online for patient to complete at the patient's convenience.
  4. Patients will undergo CTR with or without adjuvant PRP (based on assigned study group). Patients will not know which group the subject is in (single blinded).
  5. BCTQ and PROMIS will be collected online at 3 months, 6 months, and 12 months post-operatively. EMG/NCS will only be performed preoperatively and at 12 months post-operatively in the Sports Medicine clinic. At these visits, the investigators will also collect data on 2 point discrimination, grip strength, key pinch, and 3 finger pinch.
  6. The investigators will store data in REDCap.
  7. Data will be analyzed with the assistance of our biostatistician, and results will be written up.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

46

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • California
      • Redwood City, California, Forenede Stater, 94063
        • Rekruttering
        • Stanford University
        • Kontakt:
        • Kontakt:
          • Anne Kuwabara, M.D.
        • Ledende efterforsker:
          • Michael Fredericson, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Adult age 18 years and up.
  2. Diagnosed with severe CTS based on EMG/NCS, meaning those with evidence of axonal loss (absent or low amplitude median sensory nerve action potential and/or absent or low amplitude median motor nerve action potential and/or evidence of abnormal spontaneous activity, reduced recruitment, or motor unit action potential changes on needle EMG of median innervated muscles).

Exclusion Criteria:

  1. Younger than age 18 years (minor status).
  2. Diagnosed with concomitant peripheral neuropathy.
  3. Previous CTR on the affected side.
  4. Have contraindications to PRP (platelet dysfunction syndrome, critical thrombocytopenia, hemodynamic instability, septicemia, local infection at site of procedure, consistent use of NSAIDs within 48 hours of procedure, steroid injection at treatment site within 1 month, systemic use of steroids within 2 weeks, tobacco use, recent fever or illness, or cancer).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: CTR with PRP
Carpal tunnel release with adjuvant platelet-rich plasma.
Enhed: Carpal Tunnel Release with Platelet-Rich Plasma
CTR is performed with adjuvant PRP placed intra-operatively.
Placebo komparator: CTR without PRP
Carpal tunnel release without adjuvant platelet-rich plasma.
Procedure: Carpal Tunnel Release without Platelet-Rich Plasma
CTR is performed without adjuvant PRP placed intra-operatively.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Boston Carpal Tunnel Questionnaire
Tidsramme: up to 1 month pre-op
Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.
up to 1 month pre-op
Boston Carpal Tunnel Questionnaire
Tidsramme: 3 months post-op
Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.
3 months post-op
Boston Carpal Tunnel Questionnaire
Tidsramme: 6 months post-op
Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.
6 months post-op
Boston Carpal Tunnel Questionnaire
Tidsramme: 12 months post-op
Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.
12 months post-op
Grip Strength
Tidsramme: up to 1 month pre-op
Measured with a dynamometer.
up to 1 month pre-op
Grip Strength
Tidsramme: 12 months post-op
Measured with a dynamometer.
12 months post-op

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient-Reported Outcomes Measurement Information System (PROMIS)
Tidsramme: up to 1 month pre-op
Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome.
up to 1 month pre-op
Patient-Reported Outcomes Measurement Information System (PROMIS)
Tidsramme: 3 months post-op
Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome.
3 months post-op
Patient-Reported Outcomes Measurement Information System (PROMIS)
Tidsramme: 6 months post-op
Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome.
6 months post-op
Patient-Reported Outcomes Measurement Information System (PROMIS)
Tidsramme: 12 months post-op
Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome.
12 months post-op
2 Point Discrimination at Thumb
Tidsramme: up to 1 month pre-op
Minimal distance that the patient feels 2 separate points of touch.
up to 1 month pre-op
2 Point Discrimination at Thumb
Tidsramme: 12 months post-op
Minimal distance that the patient feels 2 separate points of touch.
12 months post-op
2 Point Discrimination at Index Finger
Tidsramme: up to 1 month pre-op
Minimal distance that the patient still feels 2 separate points of touch.
up to 1 month pre-op
2 Point Discrimination at Index Finger
Tidsramme: 12 months post-op
Minimal distance that the patient still feels 2 separate points of touch.
12 months post-op
2 Point Discrimination at Middle Finger
Tidsramme: up to 1 month pre-op
Minimal distance that the patient still feels 2 separate points of touch.
up to 1 month pre-op
2 Point Discrimination at Middle Finger
Tidsramme: 12 months post-op
Minimal distance that the patient still feels 2 separate points of touch.
12 months post-op
Key Pinch
Tidsramme: up to 1 month pre-op
Measured with a pinch meter.
up to 1 month pre-op
Key Pinch
Tidsramme: 12 months post-op
Measured with a pinch meter.
12 months post-op
3 Finger Pinch
Tidsramme: up to 1 month pre-op
Measured with a pinch meter.
up to 1 month pre-op
3 Finger Pinch
Tidsramme: 12 months post-op
Measured with a pinch meter.
12 months post-op
Median Motor Latency
Tidsramme: up to 1 month pre-op
From EMG/NCS data.
up to 1 month pre-op
Median Motor Latency
Tidsramme: 12 months post-op
From EMG/NCS data.
12 months post-op
Median Motor Amplitude
Tidsramme: up to 1 month pre-op
From EMG/NCS data.
up to 1 month pre-op
Median Motor Amplitude
Tidsramme: 12 months post-op
From EMG/NCS data.
12 months post-op
Median Sensory Latency
Tidsramme: up to 1 month pre-op
From EMG/NCS data.
up to 1 month pre-op
Median Sensory Latency
Tidsramme: 12 months post-op
From EMG/NCS data.
12 months post-op
Median Sensory Amplitude
Tidsramme: up to 1 month pre-op
From EMG/NCS data.
up to 1 month pre-op
Median Sensory Amplitude
Tidsramme: 12 months post-op
From EMG/NCS data.
12 months post-op
EMG of Abductor Pollicis Brevis
Tidsramme: up to 1 month pre-op
From EMG/NCS data - looking at spontaneous activity.
up to 1 month pre-op
EMG of Abductor Pollicis Brevis
Tidsramme: 12 months post-op
From EMG/NCS data - looking at spontaneous activity.
12 months post-op

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Michael Fredericson, MD

Samarbejdspartnere

Factor Medical

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. oktober 2021

Primær færdiggørelse (Forventet)

31. marts 2023

Studieafslutning (Forventet)

30. juni 2023

Datoer for studieregistrering

Først indsendt

10. marts 2021

Først indsendt, der opfyldte QC-kriterier

19. marts 2021

Først opslået (Faktiske)

23. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 59044

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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