Automated V Manual Impactor Study

NCT06903767 | Enrolling By Invitation FDA Device

• 1 other identifier: JLON1384286
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty (THA); Impaction; Physiological Strain

Outcome Measures

Primary Outcomes (1)

• Physiological strain in the surgeon

  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.

  1 day

Secondary Outcomes (2)

• Patient Adverse Events

  6 weeks

• F-NRS

  1 day

Study Arms (2)

Manual Malleting Group

ACTIVE COMPARATOR

For cases that are randomized to the manual malleting group, surgeons will utilize a manual mallet to perform impaction during total hip arthroplasty while wearing the Hexoskin shirt.

Device: Manual Malleting

Automated Impaction HAMMR Group

ACTIVE COMPARATOR

For cases that are randomized to the automated impaction HAMMR group, surgeons will utilize an automated impaction device to perform impaction during total hip arthroplasty while wearing the Hexoskin shirt.

Device: Automated Impaction (HAMMR)

Interventions

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.

Automated Impaction HAMMR Group

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.

Manual Malleting Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead
• UCLA Health - Santa Monica Medical Center: collaborator
• University of Virginia: collaborator
• Orthopedic + Fracture Specialists, Portland, OR: collaborator

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Study Officials

• Camilo Restrepo, MD

  Rothman Orthopaedic Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Trials

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: March 25, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

US (1)