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Automated V Manual Impactor Study

NCT06903767 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-04-01

No results posted yet for this study

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

Interventions

DEVICE

Automated 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.

DEVICE

Manual 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.

Sponsors & Collaborators

  • UCLA Health - Santa Monica Medical Center

    collaborator UNKNOWN

  • University of Virginia

    collaborator OTHER

  • Orthopedic + Fracture Specialists, Portland, OR

    collaborator OTHER

  • Rothman Institute Orthopaedics

    lead OTHER

Principal Investigators

  • Camilo Restrepo, MD · Rothman Orthopaedic Institute

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-25
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06903767 on ClinicalTrials.gov