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NCT Number: NCT07747831

Powered Impaction and Broaching in Elderly Total Hip Arthroplasty

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.

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Key information

Conditions

Hip Arthroplasty Replacement Gait Biomechanics Surgeon Physiologic Stress

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Concordia Joint Replacement Group / Concordia Hospital, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 70 years or older undergoing total hip replacement

Exclusion criteria

  • Unable to undergo the informed consent process

Treatment and study plan

Total Hip Replacement with Automatic impaction and broaching device

Procedure

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

Total hip replacement

Procedure

Total hip replacement without automatic impaction and broaching

Primary outcomes

  1. Incidence of Periprosthetic fracture

    Time frame: 90 days

    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)

Secondary outcomes

  1. Gait analysis

    Time frame: 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

  2. Image based implant positioning

    Time frame: 7 days

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

  3. Surgical efficiency

    Time frame: 1 day

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

  4. Surgical stress as measured by heart rate

    Time frame: 1 day

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

  5. Surgical stress as measured by respiratory rate

    Time frame: 1 day

    Measured via biometric assessment with wearable technology by the surgeon (respiratory rate - breaths/minute)

  6. Patient reported outcome measure

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jhase Sniderman

CONTACT

[email protected]

9029323130

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • DePuy Synthes

Registry information

Official study title

Demonstrating the Effect of Powered Broaching and Impaction in Direct Anterior Total Hip Arthroplasty. A Multi-centre Comparison of Patients 70 Years and Older

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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