48 Participants Needed

Surgical Approaches for Hip Arthritis

Recruiting at 1 trial location
GC
KB
Overseen ByKen Bode
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ochsner Health System
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 aims to study how different types of hip replacement surgeries affect walking. It compares three methods: manual surgery from the front of the hip (total hip arthroplasty via direct anterior approach), manual surgery from the back (total hip arthroplasty via posterior approach), and robotic-assisted surgery from the back (robotic-assisted total hip arthroplasty via posterior approach). The researchers seek to determine which approach best improves walking after surgery. Individuals with hip arthritis who can walk more than 150 feet without assistance and have not had previous hip surgery might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding the best surgical methods for enhancing mobility.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these surgical approaches are safe for hip arthritis treatment?

Research shows that robotic-assisted total hip replacement using the posterior approach is generally well-received by patients. This method reduces the likelihood of needing another surgery due to hip dislocation and enhances hip movement and comfort post-operation. Patients report better outcomes on tests measuring hip function and comfort.

For the manual direct anterior approach, earlier studies suggest it allows for quicker recovery and has a lower risk of dislocation. However, there may be a higher risk of temporary nerve issues in the thigh. Most patients handle this approach well, but it requires a skilled surgeon.

The manual posterior approach is the most common method worldwide. It provides good access to the hip and maintains muscle function. Some research indicates it might have a higher risk of dislocation, but careful surgical techniques can mitigate this risk. Overall, it is considered safe with proper care.

Each of these surgical methods has its advantages and disadvantages, but they are all generally safe, with experienced surgeons managing any risks.12345

Why are researchers excited about this trial?

Researchers are excited about these surgical approaches for hip arthritis because they each bring unique advantages to the table. The robotic-assisted posterior approach stands out by integrating computer-navigated precision, enhancing implant alignment and biomechanical restoration with tools like MAKO systems, which provide intraoperative guidance and preoperative planning. The manual direct anterior approach offers a less invasive route by preserving key soft tissues, potentially reducing dislocation rates and speeding up recovery, albeit with a challenging learning curve. Meanwhile, the manual posterior approach remains popular due to its extensive exposure and maintained abductor function, though it requires careful repair to minimize dislocation risks. Each method provides a distinct balance of benefits that could improve patient outcomes.

What evidence suggests that this trial's surgical approaches could be effective for hip arthritis?

This trial will compare different surgical approaches for hip arthritis. Research has shown that using robotic assistance for total hip replacement through the back of the hip, one of the approaches in this trial, allows precise placement of the new joint and reduces the chance of dislocation. Studies indicate that this method enhances joint function and increases patient satisfaction by ensuring better alignment and function. Another approach in this trial is the manual approach from the front of the hip, which evidence suggests helps preserve muscles and shortens recovery time, although there may be a risk of nerve problems. The manual approach from the back, also studied in this trial, is popular due to easier access, but it carries a higher risk of dislocation unless the surrounding tissues are carefully repaired. Overall, each method has proven effective in improving hip function and patient outcomes.34567

Who Is on the Research Team?

GC

George Chimento, MD

Principal Investigator

Ochsner Health System

Are You a Good Fit for This Trial?

This trial is for individuals with hip arthritis or osteoarthritis who need a total hip replacement. It's not specified, but typically participants should be adults in stable health without conditions that could affect their gait or surgery outcomes.

Inclusion Criteria

BMI less than 35
I am over 18 and having a hip replacement due to arthritis.
I can walk more than 150 feet by myself with no help.

Exclusion Criteria

I have had hip surgery on the affected side before.
I have a neurological condition that affects my walking.
I cannot have surgery using the front or back approach due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Gait and sit-to-stand analyses are performed pre-op using a Vicon motion capture system with force plates and surface EMG

1 week
1 visit (in-person)

Surgery and Initial Recovery

Participants undergo total hip arthroplasty via manual direct anterior, manual posterior, or robotic-assisted posterior approach

1-2 weeks
Hospital stay and initial recovery

Post-operative Follow-up

Gait biomechanics and patient-reported outcomes are assessed at 6 and 12 weeks post-op

12 weeks
2 visits (in-person)

Long-term Follow-up

Participants are monitored for postoperative complications and patient-reported outcomes up to 12 months

12 months
1 visit (in-person), 1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Robotic-assisted total hip arthroplasty via posterior approach
  • Total hip arthroplasty via direct anterior approach (manual, non-robotic)
  • Total hip arthroplasty via posterior approach (manual, non-robotic)
Trial Overview The study compares the walking patterns of patients after one of three types of hip replacement surgeries: manual direct anterior approach (DAA), manual posterior approach (PA), and robotic-assisted PA. The goal is to see which method leads to better gait biomechanics.
How Is the Trial Designed?
3Treatment groups
Active Control
Group I: Manual Direct Anterior Approach (DAA)Active Control1 Intervention
Group II: Manual Posterior ApproachActive Control1 Intervention
Group III: Robotic-Assisted Posterior ApproachActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ochsner Health System

Lead Sponsor

Trials
97
Recruited
91,900+

Citations

The clinical outcomes of robotic-assisted total hip ...Robotic assistance for posterior approach total hip arthroplasty is associated with lower risk of revision for dislocation when compared to ...
Robotic-Assisted Total Hip Arthroplasty Provides Greater ...The results of this meta-analysis suggest that R-THA can provide more accurate cup placement and better restoration of the native hip anatomy while reducing ...
MAKO robotic-assisted compared to conventional total hip ...MAKO robotic-arm-assisted THA significantly improves Forgotten Joint Scores, Oxford Hip Scores and reproducibility in implant positioning without compromising ...
A Systematic Review with a Minimum 2-Year Follow-UpComparison of Patient-Reported Outcome Measures Between Robotic-Assisted and Manual Total Hip Arthroplasty: A Systematic Review with a Minimum 2-Year Follow-Up.
Clinical, functional, and radiological outcomes of robotic ...RATHA has shown to offer more accurate implant placement, reduce the risk of dislocation in the posterior approach, and minimize LLD compared to ...
Robotic-Assisted Total Hip Arthroplasty Posterior ApproachRobotic-assisted total hip arthroplasty (THA) through the posterior approach is indicated in cases of symptomatic hip arthritis.
The clinical outcomes of robotic-assisted total hip...Robotic assistance for posterior approach total hip arthroplasty is associated with lower risk of revision for dislocation when compared to ...
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