Powered Impaction and Broaching in Elderly Total Hip Arthroplasty
Demonstrating the Effect of Powered Broaching and Impaction in Direct Anterior Total Hip Arthroplasty. A Multi-centre Comparison of Patients 70 Years and Older
Studieoversigt
Status
Detaljeret beskrivelse
Preparation of the femoral canal and acetabulum impaction have traditionally been accomplished with the use of a mallet and manual instruments. During manual broaching or impaction, force is transmitted with each mallet strike, which distributes horizontal forces to cortical bone. Excessive force and malalignment of instruments can lead to intraoperative fractures, or unrecognized fractures contributing to early failure of the total hip arthroplasty (THA). This risk can be elevated in direct anterior (DA) THA when exposure is compromised due to the minimally invasiveness of the approach. The advent of powered broaching devices which provide a consistent force and are more ergonomic, now provide an alternative to manual techniques. Despite its proposed benefits, it has yet to achieve widespread adoption.
The study aims to assess whether the use of a powered broaching device (KINCISE2) has an impact on intraoperative or early postoperative femoral or acetabular fractures in patients 70 years or older, when compared to traditional manual techniques in DA THA. Patients will be subgrouped based on femoral/acetabular bone quality/morphology. Secondary outcomes measured will consist of femoral canal fil, femoral version and acetabular cup-floor gap and gait analysis measures via markerless motion capture. Surgical efficiency will be measured via operative time, broaching/impaction time and surgical stress via biometric monitoring. PROMs will be measured via the short form Hip disability and Osteoarthritis Outcome Score (HOOS-Jr). Surgeons can use a standard OR table vs. a specialized traction table (HANA) and may use fluoroscopy or no intraoperative imaging.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Jhase Sniderman
- Telefonnummer: 9029323130
- E-mail: jhase.sniderman@nshealth.ca
Studiesteder
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Manitoba
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Winnipeg, Manitoba, Canada, R2K 2M9
- Concordia Joint Replacement Group / Concordia Hospital
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Kontakt:
- Trevor Gascoyne
- Telefonnummer: (204) 926-1200
- E-mail: tgascoyne@orthoinno.com
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H1C3
- Nova Scotia Health
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Kontakt:
- Jhase Sniderman
- Telefonnummer: 9029323130
- E-mail: jhasesniderman@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Patients 70 years or older undergoing total hip replacement
Exclusion Criteria:
- Unable to undergo the informed consent process
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Total Hip Replacement
Standard direct anterior total hip replacement
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Total hip replacement without automatic impaction and broaching
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Eksperimentel: Total Hip Replacement with KINCISE2
Standard direct anterior total hip replacement with KINCISE2
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Total hip replacement with the use of an automatic impaction and broaching device
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Periprosthetic fracture
Tidsramme: 90 days
|
Intraoperative or early postoperative femoral/acetabular fractures in patients 70 years or older, when compared to traditional manual techniques in DA THA.
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90 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Gait analysis
Tidsramme: 90 days
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Preoperative and postoperative markerless motion capture at 3 months - gait speed, gait symmetry, cadence, step length, stance-time symmetry and hip flexion extension
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90 days
|
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Image based implant positioning
Tidsramme: 7 days
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Measured via femoral canal fill, femoral version, acetabular floor-cup gap on postoperative CT scan
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7 days
|
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Surgical efficiency
Tidsramme: 1 day
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Measured via operative time (minutes), broaching time (minutes), impaction time (minutes)
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1 day
|
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Surgical stress as measured by heart rate
Tidsramme: 1 day
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Measured via biometric assessment with wearable technology by the surgeon (Heart rate - beats per minute)
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1 day
|
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Surgical stress as measured by respiratory rate
Tidsramme: 1 day
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Measured via biometric assessment with wearable technology by the surgeon (respiratory rate - breaths/minute)
|
1 day
|
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Patient reported outcome measure
Tidsramme: 90 days
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HOOS-JR (Hip Osteoarthritis Outcome Score - Joint Replacement).
Scale is 0-100, with zero the worst possible hip problem and 100 being no hip problem.
|
90 days
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DPS-Joints-2026-009
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- CSR
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