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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Arthroplasty Replacement; Gait Biomechanics; Surgeon Physiologic Stress
• Intervention / Treatment: Procedure: Total Hip Replacement; Procedure: Total Hip Replacement with Automatic impaction and broaching device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jhase Sniderman; Phone Number: 9029323130; Email: jhase.sniderman@nshealth.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2K 2M9
      • Concordia Joint Replacement Group / Concordia Hospital
      • Contact: Trevor Gascoyne; Phone Number: (204) 926-1200; Email: tgascoyne@orthoinno.com
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H1C3
      • Nova Scotia Health
      • Contact: Jhase Sniderman; Phone Number: 9029323130; Email: jhasesniderman@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients 70 years or older undergoing total hip replacement

Exclusion Criteria:

• Unable to undergo the informed consent process

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Total Hip Replacement; Standard direct anterior total hip replacement	Procedure: Total Hip Replacement; Total hip replacement without automatic impaction and broaching
Experimental: Total Hip Replacement with KINCISE2; Standard direct anterior total hip replacement with KINCISE2	Procedure: Total Hip Replacement with Automatic impaction and broaching device; Total hip replacement with the use of an automatic impaction and broaching device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	90 days
Image based implant positioning	Measured via femoral canal fill, femoral version, acetabular floor-cup gap on postoperative CT scan	7 days
Surgical efficiency	Measured via operative time (minutes), broaching time (minutes), impaction time (minutes)	1 day
Surgical stress as measured by heart rate	Measured via biometric assessment with wearable technology by the surgeon (Heart rate - beats per minute)	1 day
Surgical stress as measured by respiratory rate	Measured via biometric assessment with wearable technology by the surgeon (respiratory rate - breaths/minute)	1 day
Patient reported outcome measure	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

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Collaborators: DePuy Synthes

Publications and helpful links

General Publications

• Kutzer KM, Deckey DG, Florance JM, Rosas S, Mont MA, Seyler TM. Automatic Impactors in Total Hip Arthroplasty: A State-of-the-Art Review. J Arthroplasty. 2026 Jan;41(1):153-160.e1. doi: 10.1016/j.arth.2025.04.077. Epub 2025 May 6.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 23, 2026
• First Submitted That Met QC Criteria: August 3, 2026
• First Posted (Actual): August 5, 2026

Study Record Updates

• Last Update Posted (Actual): August 5, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation; Arthroplasty, Replacement, Hip
• Other Study ID Numbers: DPS-Joints-2026-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Protocol, analysis plan and results can be shared.
• IPD Sharing Time Frame: December 2028 until July 2029
• IPD Sharing Access Criteria: Researchers from academic centers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No