Automated V Manual Impactor Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Automated Impaction (HAMMR), Manual Malleting.
- Who it may be relevant to
- Registry conditions: Total Hip Arthroplasty (THA), Impaction, Physiological Strain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Do Quantifiable Differences in Physiologic Stress Exist in Surgeons When Comparing the Use of a Powered Femoral Impactor Versus Manual Impaction in Total Hip Arthroplasty?
Overview
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.
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.
Primary outcome measures
- Physiological strain in the surgeon [Time frame: 1 day]
Secondary outcome measures (2)
- Patient Adverse Events [Time frame: 6 weeks]
- F-NRS [Time frame: 1 day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Rothman Orthopaedic Institute — Philadelphia
Identifiers
NCT: NCT06903767 · JLON1384286