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Measured vs Navigated Techniques in Total Hip Arthroplasty

25. mai 2022 oppdatert av: Ottawa Hospital Research Institute

Accuracy in aChieving Optimum reconstrUction: Measured- vs. Navigation- Techniques in Hip Arthroplasty

Accurate reconstruction of the native hip parameters following total hip arthroplasty is associated with improved outcome. In order to improve ability for optimum reconstruction, 3-D templating software can be utilized that provide detailed information regarding native anatomy. In order to achieve reconstruction within acceptable parameters as per pre-operative plan, some surgeons propose the use of intra-operative devices that measure component orientation and joint reconstruction ("Measured-THA"), whilst others propose the use of navigation tools ("Navigation-THA). Both techniques have shown superiority compared to the most commonly used "freehand" technique, but no prior study has assessed for superiority between these 2 techniques. Furthermore, to-date assessment of post-operative reconstruction has not been tested in detail as post-THA assessments are based on radiographs which provide incomplete, 2-dimensional, assessments and are lacking the important axial plane reconstruction parameters. The aims of this prospective, randomized, trial are to 1. appraise the ability to achieve the pre-operative 3-D plan (as per FormusLab) through a comparison of pre-op plan to post-operative reconstruction; 2. compare ability to accurately reconstruct hip following THA between "navigated-" (IntelliJoint®) and "measured-" techniques; and in doing so it will also 3. assess the accuracy of the intra-operative assessments of reconstruction through a comparison of objective (i.e. measured) intra-operative assessments with the post-operative reconstructions achieved.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Isabel Horton
  • Telefonnummer: 73032 613-737-8899
  • E-post: ihorton@ohri.ca

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

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients who are signed for a THA for primary or secondary osteoarthritis without overt deformity that would require revision type implants and with good enough bone quality to be listed for uncemented component implantation.

Exclusion Criteria:

  • Secondary OA due to Dysplasia (Hartofilakidis >1)
  • Avascular necrosis of the hip with destruction of joint structure
  • Sequelae of Pediatric deformity with abnormal anatomy
  • Cemented fixation of femur or acetabulum
  • Previous arthroplasty-type procedure
  • Previous septic arthritis of the hip

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Measured Technique
Patients in this group will have pre-operative planning done using the measured technique.
Fremgangsmåte: Measured Technique
Manual intra-operative checks and tools are used to aid in component placement during surgery.
Eksperimentell: Navigated Technique
Patients in this group will have pre-operative planning done using the navigated technique.
Fremgangsmåte: Navigated Technique
IntelliJoint® navigation is an imageless-based navigation system that utilizes a miniature infrared camera and microelectronics to measure hip center of rotation, acetabular inclination and version, leg length, and offset. The device provides accurate real-time data on implant positioning to aid in placement of the components during surgery.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Pain Assessment - Oxford Hip Score
Tidsramme: once pre-operatively and once one-year post-operatively
The Oxford Hip Score will be given to patients to assess subjective measures of hip pain. Scores for each question from 0 to 4 with 4 being the best outcome. This method, when summed, produces overall scores running from 0 to 48 with 48 being the best outcome
once pre-operatively and once one-year post-operatively
Change in mobility, self-care, usual activities, pain/discomfort and anxiety/depression- EuroQol
Tidsramme: once pre-operatively and once one-year post-operatively

the EuroQol (EQ-5D-5L) will be given to patients to assess subjective measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
once pre-operatively and once one-year post-operatively
Change in physical, mental, and social health- PROMIS Global-10
Tidsramme: once pre-operatively and once one-year post-operatively
the PROMIS Global-10 will be given to patients to assess subjective measures of physical, mental and social health. It is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. Higher scores indicate worse physical and mental health
once pre-operatively and once one-year post-operatively
Adverse Events
Tidsramme: 90 days post-operatively

Serious adverse events will be monitored. This includes:

  • Wound complication
  • Dislocation
  • Fracture
  • Infection
  • Re-operation
  • Revision surgery
90 days post-operatively

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Accuracy of reconstruction (in mm)
Tidsramme: post-operatively (within one week post-operatively)

A measure (in mm) of how close the planned to actual reconstruction using the aforementioned reconstruction parameters. This will be assessed using:

  • Acetabular component orientation

  • Accuracy of acetabular component orientation

    o Accuracy of femoral version restoration

  • Combined version of arthroplasty in degrees

    • Accuracy of combined version restoration

  • Femoral Offset in mm

    o Accuracy of achieving femoral offset

  • Acetabular offset in mm

    o Accuracy of achieving acetabular offset

  • Total offset in mm

    o Accuracy of achieving total offset

  • Leg Length in mm o Accuracy of achieving leg length
post-operatively (within one week post-operatively)
Comparison of margin of error
Tidsramme: Through study completion, an average of 1 year
This outcome will measure what the margin of error is between intra-operatively measured values and those determined from the post-operative CT scan. This will be done using statistical analysis of data for patients in both study arms.
Through study completion, an average of 1 year
Accuracy of reconstruction on outcome
Tidsramme: Through study completion, an average of 1 year
This outcome measure will assess the accuracy of reconstruction correlate with outcome (adverse events and PROMs). This will be done by analyzing accuracy as depicted by the variables in outcome measure 5, and how these measures of accuracy correlate to patient reported outcome measure scores and rates of adverse events
Through study completion, an average of 1 year
Accuracy of reconstruction (in degrees)
Tidsramme: post-operatively (within one week post-operatively)

A measure (in degrees) of how close the planned to actual reconstruction using the aforementioned reconstruction parameters. This will be assessed using:

Acetabular component orientation (Radiographic inclination/anteversion in degrees as per Murray)

  • Accuracy of acetabular component orientation (i.e. deviation from target - aim for deviation of < ±5˚)

    ● Femoral Component Version in degrees

  • Accuracy of femoral version restoration (aim for version difference to be less than ±5˚ from pre-operative plan)

    ● Combined version of arthroplasty in degrees

  • Accuracy of combined version restoration (sum of acetabular and femoral version; aim for combined version to be less than ±10˚ from pre-operative plan)
post-operatively (within one week post-operatively)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ottawa Hospital Research Institute

Samarbeidspartnere

FormusLab

Etterforskere

  • Hovedetterforsker: George Grammatopoulos, MD, The Ottawa Hospital

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

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 (Forventet)

1. juli 2022

Primær fullføring (Forventet)

1. juli 2024

Studiet fullført (Forventet)

1. september 2024

Datoer for studieregistrering

Først innsendt

10. desember 2021

Først innsendt som oppfylte QC-kriteriene

25. mai 2022

Først lagt ut (Faktiske)

26. mai 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. mai 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. mai 2022

Sist bekreftet

1. mai 2022

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 3390

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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