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.
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.
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.
- Conditions
- Osteoarthritis, Hip, Hip Disease
- 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 group | Role | What they receive |
|---|---|---|
| Mako THA 4.0 group | Experimental | Hip 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.
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)
Pelvic tilt
measured preoperatively and intraoperatively in sitting and standing positions
Measured: Preoperatively and postoperatively at 6 weeks and 1 year
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
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
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
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
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.
- First posted27 Nov 2020
- Study start1 Jan 2021
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- American Hip Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Orthopaedics, Hospital for Special Surgery, New York
- Responsible party
- Principal investigator, Benjamin Domb, MD, American Hip Institute
- Investigators
- Benjamin G Domb, MD, Principal investigator, American Hip Institute
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04646096
- Acronym / sponsor ID
- AHI-003
- Conditions
- Osteoarthritis, Hip, Hip Disease
- Keywords
- Robotic-assisted Total Hip Arthroplasty, MAKOplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- American Hip InstituteUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics, Hospital for Special Surgery, New York
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study is a multi-center study to assess precision and accuracy of the robotic system with new software.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mako THA 4.0 group | Experimental | Device: MAKO THA 4.0 SystemHip 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAKO THA 4.0 SystemMeasure 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. | Device | Mako THA 4.0 group |
Primary outcome
Computed Tomography scan. Placement accuracy of acetabular cup and femoral stem
Time frame: 6 weeks postoperatively
Using computed tomography to assess placement accuracy, Measured in degrees
6 secondary outcomes
Pelvic tilt
Time frame: Preoperatively and postoperatively at 6 weeks and 1 year
Virtual range-of-motion
Time frame: Preoperatively and postoperatively at 6 weeks and 1 year
Patient satisfaction
Time frame: 1 year postoperative
Harris Hip Score
Time frame: preoperative and 1 year postoperative
Forgotten Joint Score
Time frame: 1 year postoperative
Hip Disability and Osteoarthritis Outcome Score
Time frame: 1 year postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Background: PubMed 30295538Nodzo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin G Domb, MD principal investigator
American Hip Institute
1 site in 1 country: see every site and its status.
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.