Automated V Manual Impactor Study

Launched by ROTHMAN INSTITUTE ORTHOPAEDICS · Mar 25, 2025

Keywords

ClinConnect Summary

This study is testing two ways to insert a hip implant during total hip replacement: a powered automated impactor (HAMMR) versus the traditional manual mallet method. Researchers want to know if the two methods affect the surgeon’s physical effort, measured with a wearable Hexoskin vest that tracks heart rate, breathing, and energy use during the operation. It is a randomized, multicenter trial, meaning cases are assigned to one method by chance and data come from several participating centers.

Adults 18 and older who are getting a first-time, elective total hip replacement with compatible implants can be eligible. Exclusions include surgeons with certain health problems or those doing non-elective or revision hip surgeries, and other standard exclusions (cognitive capacity to consent, pregnancy, etc.). Each participating surgeon is planned to contribute about 50 THA surgeries—25 with HAMMR and 25 with manual malleting—at sites like the Rothman Institute and partner centers. Participants will be followed for about 6 weeks after surgery to monitor for any adverse events, and surgeons will complete a fatigue survey after each case. The trial is open-label (no masking), and enrollment began in March 2025 with completion targeted for March 2026.

Gender

ALL

Eligibility criteria

• 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