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
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Jhase Sniderman
- Telefonnummer: 9029323130
- E-post: jhase.sniderman@nshealth.ca
Studieorter
-
-
Manitoba
-
Winnipeg, Manitoba, Kanada, R2K 2M9
- Concordia Joint Replacement Group / Concordia Hospital
-
Kontakt:
- Trevor Gascoyne
- Telefonnummer: (204) 926-1200
- E-post: tgascoyne@orthoinno.com
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-
Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H1C3
- Nova Scotia Health
-
Kontakt:
- Jhase Sniderman
- Telefonnummer: 9029323130
- E-post: jhasesniderman@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Patients 70 years or older undergoing total hip replacement
Exclusion Criteria:
- Unable to undergo the informed consent process
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Total Hip Replacement
Standard direct anterior total hip replacement
|
Total hip replacement without automatic impaction and broaching
|
|
Experimentell: Total Hip Replacement with KINCISE2
Standard direct anterior total hip replacement with KINCISE2
|
Total hip replacement with the use of an automatic impaction and broaching device
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of Periprosthetic fracture
Tidsram: 90 days
|
Intraoperative or early postoperative femoral/acetabular fractures in patients 70 years or older, when compared to traditional manual techniques in DA THA.
|
90 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Gait analysis
Tidsram: 90 days
|
Preoperative and postoperative markerless motion capture at 3 months - gait speed, gait symmetry, cadence, step length, stance-time symmetry and hip flexion extension
|
90 days
|
|
Image based implant positioning
Tidsram: 7 days
|
Measured via femoral canal fill, femoral version, acetabular floor-cup gap on postoperative CT scan
|
7 days
|
|
Surgical efficiency
Tidsram: 1 day
|
Measured via operative time (minutes), broaching time (minutes), impaction time (minutes)
|
1 day
|
|
Surgical stress as measured by heart rate
Tidsram: 1 day
|
Measured via biometric assessment with wearable technology by the surgeon (Heart rate - beats per minute)
|
1 day
|
|
Surgical stress as measured by respiratory rate
Tidsram: 1 day
|
Measured via biometric assessment with wearable technology by the surgeon (respiratory rate - breaths/minute)
|
1 day
|
|
Patient reported outcome measure
Tidsram: 90 days
|
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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DPS-Joints-2026-009
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- CSR
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