Automated vs Manual Impaction for Total Hip Replacement

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rothman Institute Orthopaedics

Disqualifiers: Cardiorespiratory, Musculoskeletal, Cognitive, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 50

Duration: 1 day per case

200 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Automated Impaction (HAMMR) 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 suggests that automated impaction might make the procedure quicker and less tiring, potentially reducing errors caused by fatigue. ^{1 2 3 4 5}

Is Automated Impaction (HAMMR) safe for use in total hip replacement surgeries?

Research on total hip replacement surgeries shows that complications can occur, such as infections, nerve injuries, and mechanical problems. However, robotic methods like robotic milling have shown fewer complications, such as no intraoperative femoral fractures, compared to manual methods, suggesting a potential safety advantage. ^{6 7 8 9 10}

How does the Automated Impaction (HAMMR) treatment differ from other treatments for total hip replacement?

The Automated Impaction (HAMMR) treatment is unique because it uses an automated surgical hammer to reduce muscle fatigue and increase surgical efficiency compared to manual malleting. This method decreases the time required to achieve the desired surgical outcome and reduces the risk of fatigue-based errors during the procedure. ^{1 7 11 12 13}

What is the purpose of this trial?

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.

Research Team

Camilo Restrepo, MD

Principal Investigator

Rothman Orthopaedic Institute

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Manual Malleting Group Active Control 1 Intervention

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 II: Automated Impaction HAMMR Group Active Control 1 Intervention

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.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary and revision total hip replacement using the Robodoc system. Bargar, WL., Bauer, A., Börner, M.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

The assessment of muscle fatigue in orthopedic surgeons, by comparing manual versus automated broaching in simulated total hip arthroplasty. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Artificial intelligence for distinguishment of hammering sound in total hip arthroplasty. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Does Automated Impaction Improve Femoral Component Sizing and Alignment in Total Hip Arthroplasty? [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical efficacy of orthopilot navigation system versus conventional manual of total hip arthroplasty: A systematic review and meta-analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Haptically guided robotic technology in total hip arthroplasty: a cadaveric investigation. [2017]

6. Sweden pubmed.ncbi.nlm.nih.gov

Patient injuries in primary total hip replacement. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison between hand rasping and robotic milling for stem implantation in cementless total hip arthroplasty. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse Events due to Lack of Precision in Total Hip Arthroplasty: The Potential of Provocation-Based CT for Diagnosis of Implant Loosening. [2021]

9. Sweden pubmed.ncbi.nlm.nih.gov

Is there a reduction in risk of revision when 36-mm heads instead of 32 mm are used in total hip arthroplasty for patients with proximal femur fractures? [2021]

10. Norway pubmed.ncbi.nlm.nih.gov

[Luxation of hip prosthesis]. [2008]

11. Germany pubmed.ncbi.nlm.nih.gov

[Computer-assisted, robot-assisted hip prosthesis--standard procedure or specialty indication?]. [2008]

12. United States pubmed.ncbi.nlm.nih.gov

Comparison of robotic-assisted and manual implantation of a primary total hip replacement. A prospective study. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Primary and revision total hip replacement using the Robodoc system. [2022]