Hip Arthroplasty ReplacementNCT07747831
Powered Impaction and Broaching in Elderly Total Hip Arthroplasty
A study testing Total Hip Replacement with Automatic impaction and broaching device and Total Hip Replacement in people with Hip Arthroplasty Replacement and Gait Biomechanics, run by Nova Scotia Health Authority at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Arthroplasty Replacement, Gait Biomechanics, Surgeon Physiologic Stress
- What is being tested?
- Total Hip Replacement with Automatic impaction and broaching device and Total Hip Replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Oct 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients 70 years or older undergoing total hip replacement
Who cannot join
- Unable to undergo the informed consent process
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
Nova Scotia Health
Halifax, Nova Scotia, B3H1C3
Jhase Sniderman, 9029323130, jhasesniderman@gmail.com
Concordia Joint Replacement Group / Concordia Hospital
Winnipeg, Manitoba, R2K 2M9
Trevor Gascoyne, (204) 926-1200, tgascoyne@orthoinno.com
About this study
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
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.
Read the 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.
- Being tested
- Total Hip Replacement with Automatic impaction and broaching device, Total Hip Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip Replacement with Automatic impaction and broaching deviceProcedure or surgery
Total hip replacement with the use of an automatic impaction and broaching device
Total Hip ReplacementProcedure or surgery
Total hip replacement without automatic impaction and broaching
| Study group | Role | What they receive |
|---|---|---|
| Total Hip Replacement | Active comparator | Standard direct anterior total hip replacement Receives: Procedure: Total Hip Replacement |
| Total Hip Replacement with KINCISE2 | Experimental | Standard direct anterior total hip replacement with KINCISE2 Receives: Procedure: Total Hip Replacement with Automatic impaction and broaching device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 90 days
Secondary outcomes (6)
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
Measured: 90 days
Image based implant positioning
Measured via femoral canal fill, femoral version, acetabular floor-cup gap on postoperative CT scan
Measured: 7 days
Surgical efficiency
Measured via operative time (minutes), broaching time (minutes), impaction time (minutes)
Measured: 1 day
Surgical stress as measured by heart rate
Measured via biometric assessment with wearable technology by the surgeon (Heart rate - beats per minute)
Measured: 1 day
Surgical stress as measured by respiratory rate
Measured via biometric assessment with wearable technology by the surgeon (respiratory rate - breaths/minute)
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip Arthroplasty ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes
- Responsible party
- Principal investigator, Jhase Sniderman, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747831
- Sponsor's protocol ID
- DPS-Joints-2026-009
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol, analysis plan and results can be shared.
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.
PubMed 40339939
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07747831
- Acronym / sponsor ID
- DPS-Joints-2026-009
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- DePuy Synthes
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Hip Replacement | Active comparator | Procedure: Total Hip ReplacementStandard direct anterior total hip replacement |
| Total Hip Replacement with KINCISE2 | Experimental | Procedure: Total Hip Replacement with Automatic impaction and broaching deviceStandard direct anterior total hip replacement with KINCISE2 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients 70 years or older undergoing total hip replacement
Key exclusion criteria (1 listed)
- Unable to undergo the informed consent process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Hip Replacement with Automatic impaction and broaching deviceTotal hip replacement with the use of an automatic impaction and broaching device | Procedure or surgery | Total Hip Replacement with KINCISE2 |
| Total Hip ReplacementTotal hip replacement without automatic impaction and broaching | Procedure or surgery | Total Hip Replacement |
Primary outcome
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)
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Background: PubMed 40339939Kutzer 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.
- Individual participant dataSharing planned: Yes. Protocol, analysis plan and results can be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Hip Replacement with Automatic impaction and broaching device and Total Hip Replacement in people with Hip Arthroplasty Replacement and Gait Biomechanics, run by Nova Scotia Health Authority at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jhase Sniderman (9029323130, jhase.sniderman@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Periprosthetic fracture (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07747831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.