Automated V Manual Impactor Study

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Rothman Institute Orthopaedics
Study ID
NCT06903767
Status
Enrolling By Invitation

Conditions

  • Impaction
  • Physiological Strain
  • Total Hip Arthroplasty (THA)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Mar 25, 2025
Status verified
Mar 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Manual Malleting Group
    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.
  • Active Comparator: Automated Impaction HAMMR Group
    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.

Primary Outcome Measure

Physiological strain in the surgeon [ Time Frame: 1 day ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rothman Orthopaedic InstitutePhiladelphiaPennsylvania19107-

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