Health TrialsbyHealthPanel

Powered Impaction and Broaching in Elderly Total Hip Arthroplasty

ConditionsHip Arthroplasty ReplacementGait BiomechanicsSurgeon Physiologic Stress
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorNova Scotia Health Authority

About this trial

Placing the parts of a hip replacement requires substantial force. This can lead to additional stress on the surgeon as well as the bone. A device was developed to help reduce this stress. This study aims to see whether this device impacts implant positioning and the surrounding bone in patients 70 years and older. It also will investigate surgeon efficiency and how patients walk after surgery.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients 70 years or older undergoing total hip replacement

Disqualifiers

Unable to undergo the informed consent process

Trial design

Design model

Parallel

Treatments tested in this trial

  • Total Hip Replacement with Automatic impaction and broaching device

    Procedure/Surgery

    Total hip replacement with the use of an automatic impaction and broaching device

  • Total Hip Replacement

    Procedure/Surgery

    Total hip replacement without automatic impaction and broaching

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Total Hip ReplacementActive comparator 1 intervention
Group B: Total Hip Replacement with KINCISE2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Periprosthetic fracture

Intraoperative or early postoperative femoral/acetabular fractures in patients 70 years or older, when compared to traditional manual techniques in DA THA. * Measured via intraoperative reporting of fracture by surgeon (Yes/No), the postoperative CT scan by the radiologist (Yes/No) (CT scan performed within 1 week of operation) and by the radiograph at 3 months/90 days by the surgeon (Yes/No) * Outcome end point: 3 months/90 days (i.e. no fracture within 90 days of surgery)

Time frame
90 days

Secondary outcomes

1

Gait analysis

Preoperative and postoperative markerless motion capture at 3 months - gait speed, gait symmetry, cadence, step length, stance-time symmetry and hip flexion extension

Time frame
90 days
2

Image based implant positioning

Measured via femoral canal fill, femoral version, acetabular floor-cup gap on postoperative CT scan

Time frame
7 days
3

Surgical efficiency

Measured via operative time (minutes), broaching time (minutes), impaction time (minutes)

Time frame
1 day
4

Surgical stress as measured by heart rate

Measured via biometric assessment with wearable technology by the surgeon (Heart rate - beats per minute)

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nova Scotia Health Authority

Lead sponsor

DePuy Synthes

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: