Automated V Manual Impactor Study

Do Quantifiable Differences in Physiologic Stress Exist in Surgeons When Comparing the Use of a Powered Femoral Impactor Versus Manual Impaction in Total Hip Arthroplasty?

Status

Enrolling by invitation

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06903767

Enrollment

200

Registered

2025-04-01

Start date

2025-03-25

Completion date

2026-03-31

Last updated

2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaction, Physiological Strain, Total Hip Arthroplasty (THA)

Brief summary

This study investigates the use of an automated impactor device in total hip arthroplasty versus manual malleting method and the physiological strain on the surgeon. This study will be a randomized, prospective, multicenter study involving fellowship-trained arthroplasty surgeons. Each participating surgeon will contribute data from 50 primary, elective THA cases, using the HAMMR powered impactor in 25 cases and manual impaction in 25 cases.

Interventions

DEVICEAutomated Impaction (HAMMR)

For cases that are randomized to the automated impaction HAMMR group, the surgeon will utilize an automated impactor device for impaction of the implant during total hip arthroplasty.

DEVICEManual Malleting

For cases that are randomized to the manual malleting group, the surgeon will utilize a mallet for impaction of the implant during total hip arthroplasty.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Patients undergoing primary elective THAs Participants over the age of 18 Patients with compatible implants

Exclusion criteria

Attending orthopaedic surgeons with pre-existing cardiorespiratory or musculoskeletal conditions Use of cemented or hybrid THA Patients undergoing a conversion or revision THA Patients undergoing a non-elective THA (i.e., for fracture) Participants lacking cognitive capacity to consent Participants who are pregnant

Design outcomes

Primary

Measure	Time frame	Description
Physiological strain in the surgeon	1 day	Through the use of a Hexoskin vest worn by the surgeon, we will measure heart rate, heart rate variability, respiratory rate, minute ventilation, and energy expenditure to determine overall physiological strain on the surgeon during total hip arthroplasty.

Secondary

Measure	Time frame	Description
Patient Adverse Events	6 weeks	Patient adverse events such as periprosthetic fractures intra- or postoperatively, intraoperative soft tissue injury, etc. will be recorded intra or postoperatively.
F-NRS	1 day	We will assess the Fatigue numeric rating scale (F-NRS) of surgeons after each case via survey.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026