Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06903767

Automated V Manual Impactor Study

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Total Hip Arthroplasty (THA) Impaction Physiological Strain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated Impaction (HAMMR)

Device

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.

Manual Malleting

Device

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.

Primary outcomes

  1. Physiological strain in the surgeon

    Time frame: 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 outcomes

  1. Patient Adverse Events

    Time frame: 6 weeks

    Patient adverse events such as periprosthetic fractures intra- or postoperatively, intraoperative soft tissue injury, etc. will be recorded intra or postoperatively.

  2. F-NRS

    Time frame: 1 day

    We will assess the Fatigue numeric rating scale (F-NRS) of surgeons after each case via survey.

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Collaborators

  • Orthopedic + Fracture Specialists, Portland, OR
  • UCLA Health - Santa Monica Medical Center
  • University of Virginia

Registry information

Official study title

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?

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2025
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.