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Powered Impaction and Broaching in Elderly Total Hip Arthroplasty

No phase Interventional Hip Arthroplasty Replacement Gait Biomechanics Surgeon Physiologic Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Total Hip Replacement with Automatic impaction and broaching device, Total Hip Replacement.
Who it may be relevant to
Registry conditions: Hip Arthroplasty Replacement, Gait Biomechanics, Surgeon Physiologic Stress. Basic parameters: from 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

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.

Interventions

  • Procedure Total Hip Replacement with Automatic impaction and broaching device
    Total hip replacement with the use of an automatic impaction and broaching device
  • Procedure Total Hip Replacement
    Total hip replacement without automatic impaction and broaching

Primary outcome measures

  • Incidence of Periprosthetic fracture [Time frame: 90 days]
Secondary outcome measures (6)
  • Gait analysis [Time frame: 90 days]
  • Image based implant positioning [Time frame: 7 days]
  • Surgical efficiency [Time frame: 1 day]
  • Surgical stress as measured by heart rate [Time frame: 1 day]
  • Surgical stress as measured by respiratory rate [Time frame: 1 day]
  • Patient reported outcome measure [Time frame: 90 days]

Eligibility criteria

Inclusion criteria

  • Patients 70 years or older undergoing total hip replacement

Exclusion criteria

  • Unable to undergo the informed consent process

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 2 centers
  • Concordia Joint Replacement Group / Concordia Hospital — Winnipeg
  • Nova Scotia Health — Halifax

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. PMID 40339939

Identifiers

NCT: NCT07747831 · DPS-Joints-2026-009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗