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Osteoarthritis, HipNCT04646096

Multicenter Study for Robotic Arm-assisted THA 4.0 System: Hip Spine Relationship

A study testing MAKO THA 4.0 System in people with Osteoarthritis, Hip and Hip Disease, run by American Hip Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The current study is a multi-center study to assess precision and accuracy of the robotic system with new software. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis, Hip, Hip Disease
What is being tested?
MAKO THA 4.0 System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
1 Jan 2021to 10 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Requires primary total hip arthroplasty surgery
  • Willing and able to comply with postoperative follow up requirements
  • at least 18 years of age
  • sign an IRB approved informed consent

Who cannot join

  • body mass index >40
  • Skeletally immature
  • patient with active infection or suspected latent infection in or about joint
  • bone stock inadequate for support or fixation of the prosthesis
  • Neuromuscular disorders, muscle atrophy, or vascular deficient in the affected limb
  • Ankylosing spondylitis

Trial locations and contacts

1 site in 1 country.

United States1 site
  • American Hip Institute

    Des Plaines, Illinois, 60018

Other trials in United States

About this study

Official title: Multicenter Study for Robotic Arm-assisted THA 4.0 System with Integration of Pelvic Tilt and ROM Assessments: Implant Position Accuracy and the Hip Spine Relationship

The current study is a multi-center study to assess precision and accuracy of the robotic system with new software.

Read the detailed description

Robotic-arm assisted surgery aims to reduce errors and improve accuracy for implant position in total hip arthroplasty (THA). In THA implant positioning plays a pivotal role in good clinical outcomes and reduces long-term wear, therefore, technology has been developed to help surgeons achieve more accurate implant position consistently. Computer-assisted navigation provides surgeon with knowledge to help guide surgeons intra-operatively with some systems computed tomography (CT)-based, others fluoroscopy based, and others imageless systems. Computer navigation has been shown to accurately place components, but does not provide the ability for patient specific pre-operative planning that CT- based robotics allows. While some may argue that robotic-arm assisted THA is more accurate, others argue that the cost and learning curve associated with robotic-arm assisted THA is not more accurate with no long-term clinical benefits. Robotic arm-assisted THA has been shown to improve accuracy of component placement and reduce outliers. Kayani et al reviewed 100 cases performed by a single surgeon with 50 THAs performed manually and 50 robotic arm-assisted. In this study, Kayani did not find a learning curve associated with achieving accuracy using the robotic arm-assisted technology; however, there was a 12 case learning curve for both himself and his operating staff that increased operative time [9]. Nodzo et al evaluated the use of the robotic arm-assisted THA using post-operative CT scans and found that both the acetabular and femoral component position were significantly accurate when compared to the intra-op position. Kamara et al reviewed a single surgeon case series to assess acetabular accuracy and found that 76% of manual THAs were within the surgeons' target zone compared to 97% of his robotic arm-assisted THAs, concluding that adoption of robotic arm-assisted THA provided significant improvement in acetabular component positioning during THA. Similarly, Redmond et al found that although there was a learning curve associated with robotic arm-assisted THA, operative time decreased with experience and acetabular component outliers decreased suggesting that while there is a learning curve with robotic arm-assisted THA the clinical benefits are better implant positioning and decreased outliers. Illgen et al reported that the improved acetabular accuracy in robotic arm-assisted THA significantly reduced dislocation rates when compared to manual THA. Bukowski et al reported robotic arm-assisted THA clinical outcomes at a minimum of 1 year and found that patients who underwent a robotic arm-assisted THA has higher clinical outcomes compared to a manual group, however, there have been no large multicenter studies that assess clinical outcomes after robotic arm-assisted THA.

In conjunction with numerous other patient-specific and surgical factors, such as age, sex, comorbidities, surgical approach, component selection, and impingement, component positioning is often cited as an important factor in optimizing THA stability. Lewinnek et al. defined the "safe zone" for component position as 40⸰±10⸰ of cup inclination and 15⸰±10⸰ of cup anteversion to minimize dislocation risk. However, recent studies have shown that not only do components continue to dislocate when placed in this zone, but that the majority of THA dislocations are positioned in this safe zone to begin with. Compounding this issue is the growing body of evidence showing that the acetabular component is not static in nature, as was the assumption with Lewinnek's safe zone, but rather dynamically changing with movement of the pelvis and spine during postural and positional changes. Alterations of the dynamic relationship between the hip, spine, and pelvis in patients with hip-spine pathology during movements such as transitioning from standing to sitting affects typical pelvic biomechanical accommodation, resulting in THA component impingement, instability, and dislocation. Therefore, patients with spinopelvic pathology secondary to arthritis, spinal fusion, or spinal deformity are more prone to dislocation and revision following primary THA. The standard modality for assessing hip component position postoperatively is a 2D anteroposterior radiograph, due to low radiation dose and low cost. However, hip replacement components are placed in a 3-dimensional pelvis and femur, and therefore an anteroposterior radiograph alone may not give accurate information on the anteversion of the acetabular or femoral component. Studies have shown that cup anteversion measured with radiographs can have serious deviations with a substantial error range (mean deviation +1.74°, range -16.6° to 29.8°). This is attributed to the fact that radiographs cannot control for pelvic rotation and/or tilt. Recently a limited number of studies have started to use the other imaging modalities for understanding pelvic tilt in patients undergoing hip arthroplasty.

Being tested
MAKO THA 4.0 System
Keywords
Robotic-assisted Total Hip Arthroplasty, MAKOplasty
Medical subject headings
Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAKO THA 4.0 SystemDevice

    Measure how the accuracy and precision of robotic arm-assisted total hip arthroplasty (THA) for placement accuracy of implant position in both the anterior and posterior approach.. The intervention will assess the precision of the MAKO system in placing hip components according to plan. It will compare hip angles executed by the Mako system intraoperatively with the 'gold standard' of 3D computer tomography (CT) scans.

    The postoperative CT scan can show the precision of the MAKO system by accurately determining the location of hip replacements in patients after surgery.

Study groups in NCT04646096
Study groupRoleWhat they receive
Mako THA 4.0 groupExperimentalHip system used: femoral stem (Accolade II), acetabular cup (Trident II or MDM if necessary), femoral head (ceramic or metal head compatible with Accolade II), acetabular insert (X3 Trident II or MDM liner when using MDM cup). Mako THA 4.0 software also will be used.
Receives: Device: MAKO THA 4.0 System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Computed Tomography scan. Placement accuracy of acetabular cup and femoral stem

    Using computed tomography to assess placement accuracy, Measured in degrees

    Measured: 6 weeks postoperatively

Secondary outcomes (6)
  1. Pelvic tilt

    measured preoperatively and intraoperatively in sitting and standing positions

    Measured: Preoperatively and postoperatively at 6 weeks and 1 year

  2. Virtual range-of-motion

    measured preoperatively and intraoperatively in sitting and standing positions using virtual range of motion impingement modeling

    Measured: Preoperatively and postoperatively at 6 weeks and 1 year

  3. Patient satisfaction

    Measured in a scale of 0-10 to determine how satisfied a patient is with their procedure. A score of 10 indicates most satisfied, a score of 0 is least satisfied.

    Measured: 1 year postoperative

  4. Harris Hip Score

    Questionnaire. A measure of functionality of the operated hip. Measured scale: 0-100. Lower score means worse functional outcome.

    Measured: preoperative and 1 year postoperative

  5. Forgotten Joint Score

    Assess likelihood the patient has forgotten that they had a hip replacement. Measured scale: 0-100. Higher score means better feeling of normalcy.

    Measured: 1 year postoperative

  6. Hip Disability and Osteoarthritis Outcome Score

    Assess pain and function. Measured scale: 0-100. Higher the score, the greater the outcome and patient experience.

    Measured: 1 year postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2020
  2. Study start1 Jan 2021
  3. Primary completion10 Oct 2024
  4. Study completion10 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04646096
Sponsor's protocol ID
AHI-003
Status last verified
Jan 2025
First submitted
18 Nov 2020
Last updated
29 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Nodzo SR, Chang CC, Carroll KM, Barlow BT, Banks SA, Padgett DE, Mayman DJ, Jerabek SA. Intraoperative placement of total hip arthroplasty components with robotic-arm assisted technology correlates with postoperative implant position: a CT-based study. Bone Joint J. 2018 Oct;100-B(10):1303-1309. doi: 10.1302/0301-620X.100B10-BJJ-2018-0201.R1.

    PubMed 30295538

Questions about this trial

What is this clinical trial studying?

A study testing MAKO THA 4.0 System in people with Osteoarthritis, Hip and Hip Disease, run by American Hip Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Computed Tomography scan. Placement accuracy of acetabular cup and femoral stem (time frame: 6 weeks postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04646096, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.

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Clinical Trial NCT04646096 | AzTrials