- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02717299
Making Sense Out of Total Knee Sensor Assisted Technology: A Randomized Control Trial
30. april 2020 opdateret af: TriHealth Inc.
The purpose of this study is to compare the patient reported outcome measures of total knee replacement patients who received intra operative sensor guided technique for soft tissue balancing to a group of patients who receive surgeon guided soft tissue balancing.
Studieoversigt
Detaljeret beskrivelse
This study will compare a group of total knee arthroplasty patients who receive sensor guidance technology for soft tissue balancing intra operatively to a group of patients who receive surgeon guided soft tissue balancing.
Patients will be randomized to either the experimental group with the sensor guided technology or the control group which is the surgeon guided technique and current standard of care.
All patients will have the sensor placed intra operatively so that measurements can be captured and recorded however, the measurements for the patients who are not in the sensor guided group will not be revealed to the surgeon.
The information will be gathered for post enrollment data analysis only.
The patients measurements in the sensor guided group will be revealed to the surgeon and the surgeon will use this information in order to help guide soft tissue balancing for optimal alignment intra operatively.
Patients will be followed for 1 year post operatively.
Patient reported outcomes measures such as KSS, KOOS, PROMIS PF CAT, EQ-5D and UCLA activity will be collected preoperatively and at 3 months, 6 months, and 12 months.
Post-operative Likert scale patient satisfaction scores will also be collected.
All outcomes will be scored and compared to determine significance.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
78
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45220
- Good Samarian Hospital
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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:
- Patients undergoing primary unilateral total knee arthroplasty for osteoarthritis, avascular necrosis, inflammatory arthropathy, or post traumatic arthritis.
- Patients able to understand study intent, and agree to study participation.
- Patients receiving Smith and Nephew Journey II total knee implant system.
Exclusion Criteria:
- Patients with previous ipsilateral knee ligament surgery.
- Patients with orthopaedic and medical co-morbidities that would thwart postoperative recovery such as extra-articular pathology with referred pain to the knee (spinal stenosis, neuropathy, ipsilateral hip disease), severe knee deformity.
- Untreated Osteoarthritis
- BMI > 40
- ASA class > III
- History of drug or alcohol abuse
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 |
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Eksperimentel: Sensor Guided Tissue Balancing
Patients in this group will have the Verasense trial sensor device inserted, and the data collected electronically.
The surgeon will use this data to intraoperatively align the knee according to the indications of the data.
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Verasense will collect balancing data on all patients in this trial.
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Placebo komparator: Surgeon Guided Tissue Balancing
Patients in this group will have the Verasense trial sensor device inserted, and the data collected electronically.
The computer displaying the data will be turned away from the surgeon, so that he is not able to use the sensor data, and must balance the knee with feel and visual estimation of balance.
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Verasense will collect balancing data on all patients in this trial.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Patient Satisfaction
Tidsramme: Surgery to 12 months post-operative
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Overall Patient Satisfaction will be reported through various surveys.
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Surgery to 12 months post-operative
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mark Snyder, MD, TriHealth Inc.
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)
1. november 2015
Primær færdiggørelse (Faktiske)
1. april 2019
Studieafslutning (Forventet)
8. april 2021
Datoer for studieregistrering
Først indsendt
15. marts 2016
Først indsendt, der opfyldte QC-kriterier
22. marts 2016
Først opslået (Skøn)
23. marts 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. maj 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. april 2020
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 15-053
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Yes, Orthosensor receives the data collected.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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