Automated vs Manual Impaction for Total Hip Replacement
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two methods for hip replacement surgery: an automated device called HAMMR (Automated Impaction) and the traditional manual mallet. The goal is to determine which method improves surgical outcomes and reduces the surgeon's physical effort. Candidates for the trial include individuals undergoing elective primary hip replacement with compatible implants. Surgeons will perform 50 surgeries each, using both methods to compare results. As an unphased trial, this study allows patients to contribute to advancements in surgical techniques and potentially benefit from innovative technology.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that the automated impactor device is safe for total hip arthroplasty?
Research has shown that the HAMMR automated impactor used in hip surgeries can reduce the strain and fatigue experienced by surgeons. It operates more quickly than manual methods, easing the surgical process. No specific safety concerns have been reported with the HAMMR device itself. The primary goal is to make surgeries quicker and easier for surgeons. As this trial does not involve a new drug or treatment, patient safety is not the main focus. Instead, the study examines how the device impacts the surgical process and the surgeon's experience.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it compares two different methods of impaction during total hip replacement surgery: automated impaction using the HAMMR device and traditional manual malleting. The automated HAMMR device is unique because it aims to provide consistent and precise force, potentially reducing the risk of variability and surgeon fatigue. This could lead to more predictable outcomes and quicker surgeries. On the other hand, manual malleting, the current standard, relies on the surgeon's strength and skill, which can vary. By comparing these methods, researchers hope to find out if the automated approach can enhance surgical precision and improve patient recovery.
What evidence suggests that automated and manual impaction methods are effective for total hip replacement?
This trial will compare two methods for total hip replacement: Automated Impaction using the HAMMR device and Manual Malleting. Research has shown that using an automated tool, like the HAMMR device, in hip replacement surgery can make the process quicker and more consistent. Studies have found that it significantly reduces the time needed for femoral broaching and lessens the physical effort required from surgeons. As a result, surgeons experience less fatigue, potentially leading to better patient outcomes. In contrast, using a manual tool relies on the surgeon's strength and accuracy, which can vary. Overall, the automated method may offer a more efficient and less tiring option for hip replacement surgeries.12345
Who Is on the Research Team?
Camilo Restrepo, MD
Principal Investigator
Rothman Orthopaedic Institute
Are You a Good Fit for This Trial?
This trial is for fellowship-trained arthroplasty surgeons who will perform total hip replacements. Each surgeon must contribute data from 50 primary, elective total hip arthroplasty (THA) cases. The eligibility criteria are not fully listed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Surgeons perform total hip arthroplasty using either a manual mallet or an automated impactor device, while physiological strain is measured.
Follow-up
Patient adverse events are monitored intra- and postoperatively for 6 weeks.
What Are the Treatments Tested in This Trial?
Interventions
- Automated Impaction (HAMMR)
- Manual Malleting
Trial Overview
The study compares the use of an automated impactor device (HAMMR) versus the traditional manual malleting method during total hip replacements to assess the physiological strain on surgeons. It's a randomized, prospective, multicenter study with each surgeon using both methods in an equal number of cases.
How Is the Trial Designed?
2
Treatment groups
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rothman Institute Orthopaedics
Lead Sponsor
UCLA Health - Santa Monica Medical Center
Collaborator
University of Virginia
Collaborator
Orthopedic + Fracture Specialists, Portland, OR
Collaborator
Published Research Related to This Trial
Citations
Automatic Impactors in Total Hip Arthroplasty: A State-of- ...
Automated impactors demonstrated significant reductions in femoral broaching time, improved consistency, and reduced surgeon fatigue compared to manual methods.
Review Article Automatic Impactors in Total Hip Arthroplasty
Automated impactors demonstrated significant reductions in femoral broaching time, improved consistency, and reduced surgeon fatigue compared to manual methods.
Automatic Impactors in Total Hip Arthroplasty: A State-of- ...
Automated impactors demonstrated significant reductions in femoral broaching time, improved consistency, and reduced surgeon fatigue compared to ...
Automated vs Manual Impaction for Total Hip Replacement
Research shows that using an automated surgical hammer can reduce muscle fatigue and increase efficiency for surgeons during hip replacement surgery. This ...
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zimmerbiomet.com
zimmerbiomet.com/en/products-and-solutions/specialties/hip/hammr-automated-hip-impaction-system.htmlHAMMR® Automated Hip Surgical Impactor System
The HAMMR Automated Hip Impaction System is designed to address surgeon strain, fatigue, and repetitive motion associated with the traditional mallet.
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