SurgeryNCT03891199
Two Year Study With Robotic-Arm Assisted Hip Surgery.
A study testing Robotic-Arm Assisted THA in people with Surgery and Hip Osteoarthritis, run by West Virginia University at 1 site in United States.
Trial summary
This study will involve a quantitative assessment of prospectively collected computed tomography, radiographic and patient outcomes data from multiple centers. Specifically looking at acetabular cup placement during Total Hip Arthroplasty by either traditional or robotic-arm assisted placement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery, Hip Osteoarthritis
- What is being tested?
- Robotic-Arm Assisted THA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2019to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients requiring primary total hip arthroplasty
- Patients willing and able to comply with follow-up requirements
- Patients willing to sign an Institutional Review Board approved informed consent form.
Who cannot join
- Patients with Body Mass Index >45
- Patients who are <18 years of age
- Patients with an active infection or suspected latent infection in or about the hip joint
- Bone stock that is inadequate for support or fixation of the prosthesis
- Previous major hip surgery excluding hip arthroscopy
- Total hip arthroplasty using cement fixation or resurfacing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two Year Multicenter Study of Robotic-Arm Assisted THA: Acetabular Cup Placement Accuracy and Clinical Outcomes
This study will involve a quantitative assessment of prospectively collected computed tomography, radiographic and patient outcomes data from multiple centers. Specifically looking at acetabular cup placement during Total Hip Arthroplasty by either traditional or robotic-arm assisted placement.
Read the detailed description
The incidence of dislocation following total hip arthroplasty (THA) has been reported to be from 1% to as much as 3.2%. The demand for THA is expected to increase. Post- dislocation solutions include closed reduction, open reduction, THA revision, and constrained cup, conversion to hemiarthroplasty, allograft or girdlestone resection. These solutions are often costly, painful and can involve substantial additional risks and complications. Acetabular cup placement is an important factor in the stability of the THA. Cup malpositioning has been associated with bearing surface ware and dislocation. For most patients, acceptable angles for abduction are 40° abduction (±10°) and 20° (±5°) version. However, malpositioning continues to occur resulting in cup angles outside acceptable ranges and leaving patients with an increased risk of dislocation.
This objective of this study is to examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.
- Conditions
- Surgery, Hip Osteoarthritis
- Being tested
- Robotic-Arm Assisted THA
- Keywords
- clinical trial, randomization, hip arthroplasty
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-Arm Assisted THAProcedure or surgery
The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Traditional THA. |
| Intervention | Active comparator | Robotic-arm assisted THA. Receives: Procedure: Robotic-Arm Assisted THA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Version.
Accuracy of cup placement will be measured by absolute value of degrees from target version (40 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone.
Measured: 6 months
Change in Patient Reported "Hip Dysfunction and Osteoarthritis Outcome Score" (HOOS) Survey Over 1 Year Period.
The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process . To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. To calculate the total HOOS score the subscales need to be summed up.
Measured: 1 Year
Change in "Patient-Reported Outcomes Measurement Information System" (PROMIS) Survey Over a 1 Year Period.
The PROMIS Global-10 is a global health quality of life patient reported outcome tool. It is part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It measures symptoms, functioning, and healthcare quality of life for a wide variety of conditions. The PROMIS Global-10 consists of 10 questions assessing physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. 7 questions inquire about health in "general" and 3 questions assess emotional problems, fatigue and pain in the last 7 days.
PROMIS 10 Global Physical Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse physical health and 20 equals the best physical health). PROMIS 10 Global Mental Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse mental health and 20 equals the best mental health)
Measured: 1year
Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Inclination.
Accuracy of cup placement will be measured by absolute value of degrees from target inclination (20 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone.
Measured: 6 months
Adherence to Lewinnek Safe Zone
5-25 degrees of anteversion; 30-50 degrees of inclination.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start8 Apr 2019
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic, West Penn Allegheny Health System
- Responsible party
- Principal investigator, Matthew Dietz, MD, West Virginia University
- Investigators
- Matthew J Dietz, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891199
- Sponsor's protocol ID
- 1808218345
- Status last verified
- Aug 2023
- First submitted
- 15 Mar 2019
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All patient outcomes data will be entered by the on-site research assistant into the REDCap study site created and managed at the Principal Investigators institution by the primary research coordinator. The REDCap site will house the study data and provide a means for the remote site research assistant to enter patient demographics, medical history, surgical details and outcome results. Medical history, demographic, and surgical details.
Publications
Banerjee S, Cherian JJ, Elmallah RK, Pierce TP, Jauregui JJ, Mont MA. Robot-assisted total hip arthroplasty. Expert Rev Med Devices. 2016;13(1):47-56. doi: 10.1586/17434440.2016.1124018. Epub 2015 Dec 21.
PubMed 26592900Elson L, Dounchis J, Illgen R, Marchand RC, Padgett DE, Bragdon CR, Malchau H. Precision of acetabular cup placement in robotic integrated total hip arthroplasty. Hip Int. 2015 Nov-Dec;25(6):531-6. doi: 10.5301/hipint.5000289. Epub 2015 Sep 10.
PubMed 26391264Kanawade V, Dorr LD, Banks SA, Zhang Z, Wan Z. Precision of robotic guided instrumentation for acetabular component positioning. J Arthroplasty. 2015 Mar;30(3):392-7. doi: 10.1016/j.arth.2014.10.021. Epub 2014 Oct 22.
PubMed 25453633Werner SD, Stonestreet M, Jacofsky DJ. Makoplasty and the accuracy and efficacy of robotic-assisted arthroplasty. Surg Technol Int. 2014 Mar;24:302-6.
PubMed 24574012Tarwala R, Dorr LD. Robotic assisted total hip arthroplasty using the MAKO platform. Curr Rev Musculoskelet Med. 2011 Sep;4(3):151-6. doi: 10.1007/s12178-011-9086-7.
PubMed 21728013Callanan MC, Jarrett B, Bragdon CR, Zurakowski D, Rubash HE, Freiberg AA, Malchau H. The John Charnley Award: risk factors for cup malpositioning: quality improvement through a joint registry at a tertiary hospital. Clin Orthop Relat Res. 2011 Feb;469(2):319-29. doi: 10.1007/s11999-010-1487-1.
PubMed 20717858Woo RY, Morrey BF. Dislocations after total hip arthroplasty. J Bone Joint Surg Am. 1982 Dec;64(9):1295-306.
PubMed 7142237Lewinnek GE, Lewis JL, Tarr R, Compere CL, Zimmerman JR. Dislocations after total hip-replacement arthroplasties. J Bone Joint Surg Am. 1978 Mar;60(2):217-20.
PubMed 641088Domb BG, El Bitar YF, Sadik AY, Stake CE, Botser IB. Comparison of robotic-assisted and conventional acetabular cup placement in THA: a matched-pair controlled study. Clin Orthop Relat Res. 2014 Jan;472(1):329-36. doi: 10.1007/s11999-013-3253-7. Epub 2013 Aug 29.
PubMed 23990446Banerjee S, Cherian JJ, Elmallah RK, Jauregui JJ, Pierce TP, Mont MA. Robotic-assisted knee arthroplasty. Expert Rev Med Devices. 2015;12(6):727-35. doi: 10.1586/17434440.2015.1086264. Epub 2015 Sep 12.
PubMed 26365088Roche M. Robotic-assisted unicompartmental knee arthroplasty: the MAKO experience. Orthop Clin North Am. 2015 Jan;46(1):125-31. doi: 10.1016/j.ocl.2014.09.008.
PubMed 25435041Soong M, Rubash HE, Macaulay W. Dislocation after total hip arthroplasty. J Am Acad Orthop Surg. 2004 Sep-Oct;12(5):314-21. doi: 10.5435/00124635-200409000-00006.
PubMed 15469226Pellicci PM, Bostrom M, Poss R. Posterior approach to total hip replacement using enhanced posterior soft tissue repair. Clin Orthop Relat Res. 1998 Oct;(355):224-8. doi: 10.1097/00003086-199810000-00023.
PubMed 9917607Ghelman B, Kepler CK, Lyman S, Della Valle AG. CT outperforms radiography for determination of acetabular cup version after THA. Clin Orthop Relat Res. 2009 Sep;467(9):2362-70. doi: 10.1007/s11999-009-0774-1. Epub 2009 Mar 10.
PubMed 19277802Redmond JM, Gupta A, Hammarstedt JE, Petrakos A, Stake CE, Domb BG. Accuracy of Component Placement in Robotic-Assisted Total Hip Arthroplasty. Orthopedics. 2016 May 1;39(3):193-9. doi: 10.3928/01477447-20160404-06. Epub 2016 Apr 12.
PubMed 27064781
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Year Multicenter Study of Robotic-Arm Assisted THA: Acetabular Cup Placement Accuracy and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT03891199
- Acronym / sponsor ID
- 1808218345
- Conditions
- Surgery, Hip Osteoarthritis
- Keywords
- clinical trial, randomization, hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- Stryker Nordic, West Penn Allegheny Health System
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will involve a quantitative assessment of prospectively collected computed tomography, radiographic and patient outcomes data from multiple centers. Specifically looking at acetabular cup placement during Total Hip Arthroplasty by either traditional or robotic-arm assisted placement.
Detailed description
The incidence of dislocation following total hip arthroplasty (THA) has been reported to be from 1% to as much as 3.2%. The demand for THA is expected to increase. Post- dislocation solutions include closed reduction, open reduction, THA revision, and constrained cup, conversion to hemiarthroplasty, allograft or girdlestone resection. These solutions are often costly, painful and can involve substantial additional risks and complications. Acetabular cup placement is an important factor in the stability of the THA. Cup malpositioning has been associated with bearing surface ware and dislocation. For most patients, acceptable angles for abduction are 40° abduction (±10°) and 20° (±5°) version. However, malpositioning continues to occur resulting in cup angles outside acceptable ranges and leaving patients with an increased risk of dislocation.
This objective of this study is to examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Traditional THA. |
| Intervention | Active comparator | Procedure: Robotic-Arm Assisted THARobotic-arm assisted THA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients requiring primary total hip arthroplasty
- Patients willing and able to comply with follow-up requirements
- Patients willing to sign an Institutional Review Board approved informed consent form.
Key exclusion criteria (6 listed)
- Patients with Body Mass Index >45
- Patients who are <18 years of age
- Patients with an active infection or suspected latent infection in or about the hip joint
- Bone stock that is inadequate for support or fixation of the prosthesis
- Previous major hip surgery excluding hip arthroscopy
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 |
|---|---|---|
| Robotic-Arm Assisted THAThe study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA. | Procedure or surgery | Intervention |
Primary outcome
Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Version.
Time frame: 6 months
Accuracy of cup placement will be measured by absolute value of degrees from target version (40 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone.
Change in Patient Reported "Hip Dysfunction and Osteoarthritis Outcome Score" (HOOS) Survey Over 1 Year Period.
Time frame: 1 Year
The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process . To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. To calculate the total HOOS score the subscales need to be summed up.
Change in "Patient-Reported Outcomes Measurement Information System" (PROMIS) Survey Over a 1 Year Period.
Time frame: 1year
The PROMIS Global-10 is a global health quality of life patient reported outcome tool. It is part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It measures symptoms, functioning, and healthcare quality of life for a wide variety of conditions. The PROMIS Global-10 consists of 10 questions assessing physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. 7 questions inquire about health in "general" and 3 questions assess emotional problems, fatigue and pain in the last 7 days. PROMIS 10 Global Physical Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse physical health and 20 equals the best physical health). PROMIS 10 Global Mental Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse mental health and 20 equals the best mental health)
Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Inclination.
Time frame: 6 months
Accuracy of cup placement will be measured by absolute value of degrees from target inclination (20 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone.
Adherence to Lewinnek Safe Zone
Time frame: 6 month
5-25 degrees of anteversion; 30-50 degrees of inclination.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26592900Banerjee S, Cherian JJ, Elmallah RK, Pierce TP, Jauregui JJ, Mont MA. Robot-assisted total hip arthroplasty. Expert Rev Med Devices. 2016;13(1):47-56. doi: 10.1586/17434440.2016.1124018. Epub 2015 Dec 21.
- Background: PubMed 26391264Elson L, Dounchis J, Illgen R, Marchand RC, Padgett DE, Bragdon CR, Malchau H. Precision of acetabular cup placement in robotic integrated total hip arthroplasty. Hip Int. 2015 Nov-Dec;25(6):531-6. doi: 10.5301/hipint.5000289. Epub 2015 Sep 10.
- Background: PubMed 25453633Kanawade V, Dorr LD, Banks SA, Zhang Z, Wan Z. Precision of robotic guided instrumentation for acetabular component positioning. J Arthroplasty. 2015 Mar;30(3):392-7. doi: 10.1016/j.arth.2014.10.021. Epub 2014 Oct 22.
- Background: PubMed 24574012Werner SD, Stonestreet M, Jacofsky DJ. Makoplasty and the accuracy and efficacy of robotic-assisted arthroplasty. Surg Technol Int. 2014 Mar;24:302-6.
- Background: PubMed 21728013Tarwala R, Dorr LD. Robotic assisted total hip arthroplasty using the MAKO platform. Curr Rev Musculoskelet Med. 2011 Sep;4(3):151-6. doi: 10.1007/s12178-011-9086-7.
- Background: PubMed 20717858Callanan MC, Jarrett B, Bragdon CR, Zurakowski D, Rubash HE, Freiberg AA, Malchau H. The John Charnley Award: risk factors for cup malpositioning: quality improvement through a joint registry at a tertiary hospital. Clin Orthop Relat Res. 2011 Feb;469(2):319-29. doi: 10.1007/s11999-010-1487-1.
- Background: PubMed 7142237Woo RY, Morrey BF. Dislocations after total hip arthroplasty. J Bone Joint Surg Am. 1982 Dec;64(9):1295-306.
- Background: PubMed 641088Lewinnek GE, Lewis JL, Tarr R, Compere CL, Zimmerman JR. Dislocations after total hip-replacement arthroplasties. J Bone Joint Surg Am. 1978 Mar;60(2):217-20.
- Background: PubMed 23990446Domb BG, El Bitar YF, Sadik AY, Stake CE, Botser IB. Comparison of robotic-assisted and conventional acetabular cup placement in THA: a matched-pair controlled study. Clin Orthop Relat Res. 2014 Jan;472(1):329-36. doi: 10.1007/s11999-013-3253-7. Epub 2013 Aug 29.
- Background: PubMed 26365088Banerjee S, Cherian JJ, Elmallah RK, Jauregui JJ, Pierce TP, Mont MA. Robotic-assisted knee arthroplasty. Expert Rev Med Devices. 2015;12(6):727-35. doi: 10.1586/17434440.2015.1086264. Epub 2015 Sep 12.
- Background: PubMed 25435041Roche M. Robotic-assisted unicompartmental knee arthroplasty: the MAKO experience. Orthop Clin North Am. 2015 Jan;46(1):125-31. doi: 10.1016/j.ocl.2014.09.008.
- Background: PubMed 15469226Soong M, Rubash HE, Macaulay W. Dislocation after total hip arthroplasty. J Am Acad Orthop Surg. 2004 Sep-Oct;12(5):314-21. doi: 10.5435/00124635-200409000-00006.
- Individual participant dataSharing planned: Yes. All patient outcomes data will be entered by the on-site research assistant into the REDCap study site created and managed at the Principal Investigators institution by the primary research coordinator. The REDCap site will house the study data and provide a means for the remote site research assistant to enter patient demographics, medical history, surgical details and outcome results. Medical history, demographic, and surgical details.
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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.
Matthew J Dietz, MD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-Arm Assisted THA in people with Surgery and Hip Osteoarthritis, run by West Virginia University 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 3 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 12 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Version. (time frame: 6 months). The study lists 5 primary outcomes in all. 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 NCT03891199, which also lists 19 linked publications.
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 12 Mar 2024; AzTrials last refreshed its copy on 29 Oct 2026.