Automated V Manual Impactor Study

NCT ID: NCT06903767

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-25

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Total Hip Arthroplasty (THA) Impaction Physiological Strain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Manual Malleting

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Automated Impaction (HAMMR)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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UCLA Health - Santa Monica Medical Center

UNKNOWN

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role collaborator

Orthopedic + Fracture Specialists, Portland, OR

OTHER

Sponsor Role collaborator

Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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tnicholson

Director of Clinical Trials

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Camilo Restrepo, MD

Role: STUDY_DIRECTOR

Rothman Orthopaedic Institute

Locations

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Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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JLON1384286

Identifier Type: -

Identifier Source: org_study_id

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