NCT07747831

Brief 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. It also will investigate surgeon efficiency and how patients walk after surgery.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
26mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

August 5, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 23, 2026

Last Update Submit

August 3, 2026

Conditions

Gait BiomechanicsSurgeon Physiologic StressHip Arthroplasty Replacement

Outcome Measures

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)

    90 days

Secondary Outcomes (6)

  • Gait analysis

    90 days

  • Image based implant positioning

    7 days

  • Surgical efficiency

    1 day

  • Surgical stress as measured by heart rate

    1 day

  • Surgical stress as measured by respiratory rate

    1 day

  • +1 more secondary outcomes

Study Arms (2)

Total Hip Replacement

ACTIVE COMPARATOR

Standard direct anterior total hip replacement

Procedure: Total Hip Replacement

Total Hip Replacement with KINCISE2

EXPERIMENTAL

Standard direct anterior total hip replacement with KINCISE2

Procedure: Total Hip Replacement with Automatic impaction and broaching device

Interventions

Total Hip Replacement with Automatic impaction and broaching devicePROCEDURE

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

Total Hip Replacement with KINCISE2
Total Hip ReplacementPROCEDURE

Total hip replacement without automatic impaction and broaching

Total Hip Replacement

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients 70 years or older undergoing total hip replacement

You may not qualify if:

  • Unable to undergo the informed consent process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Concordia Joint Replacement Group / Concordia Hospital

Winnipeg, Manitoba, R2K 2M9, Canada

Location

Nova Scotia Health

Halifax, Nova Scotia, B3H1C3, Canada

Location

Related Publications (1)

  • 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: 40339939BACKGROUND

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Central Study Contacts

Jhase Sniderman

CONTACT

9029323130jhase.sniderman@nshealth.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

July 23, 2026

First Posted

August 5, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

August 5, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

Protocol, analysis plan and results can be shared.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
December 2028 until July 2029
Access Criteria
Researchers from academic centers
More information

Locations

CA(2)