Automated V Manual Impactor Study

Rothman Institute Orthopaedics

Status: Invitation-only

Conditions: Impaction; Physiological Strain; Total Hip Arthroplasty (THA)

Treatments: Device: Manual Malleting; Device: Automated Impaction (HAMMR)

Study type: Interventional

Funder types: Other

Identifiers

NCT06903767

JLON1384286

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Manual Malleting Group

Active Comparator group

Description:

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.

Treatment:

Device: Manual Malleting

Automated Impaction HAMMR Group

Active Comparator group

Description:

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.

Treatment:

Device: Automated Impaction (HAMMR)