Automated vs Manual Impaction for Total Hip Replacement

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rothman Institute Orthopaedics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

CR

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

Patients with compatible implants
I am scheduled for a first-time hip replacement surgery.
I am over 18 years old.

Exclusion Criteria

Participants who are pregnant
I am having a hip replacement due to a fracture.
I am an orthopaedic surgeon with existing heart, lung, or muscle/bone conditions.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Surgeons perform total hip arthroplasty using either a manual mallet or an automated impactor device, while physiological strain is measured.

1 day per case
50 cases per surgeon

Follow-up

Patient adverse events are monitored intra- and postoperatively for 6 weeks.

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?
2Treatment groups
Active Control
Group I: Manual Malleting GroupActive Control1 Intervention
Group II: Automated Impaction HAMMR GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rothman Institute Orthopaedics

Lead Sponsor

Trials
127
Recruited
22,600+

UCLA Health - Santa Monica Medical Center

Collaborator

Trials
2
Recruited
380+

University of Virginia

Collaborator

Trials
802
Recruited
1,342,000+

Orthopedic + Fracture Specialists, Portland, OR

Collaborator

Trials
3
Recruited
1,100+

Published Research Related to This Trial

The ROBODOC system, used in cementless total hip replacements, showed statistically better fit and positioning of the femoral component compared to traditional methods, as evaluated by radiographs in a study of 136 patients.
In a larger German study of 900 hip replacements, the ROBODOC system demonstrated a significant improvement in patient outcomes (Harris hip score increased from 43.7 to 91.5) and eliminated intraoperative femoral fractures, suggesting it is a safe and effective option for hip replacement surgery.
Primary and revision total hip replacement using the Robodoc system.Bargar, WL., Bauer, A., Börner, M.[2022]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40339939/
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 ArthroplastyAutomated 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 ReplacementResearch shows that using an automated surgical hammer can reduce muscle fatigue and increase efficiency for surgeons during hip replacement surgery. This ...
HAMMR® Automated Hip Surgical Impactor SystemThe HAMMR Automated Hip Impaction System is designed to address surgeon strain, fatigue, and repetitive motion associated with the traditional mallet.
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