OsteoarthritisNCT01672320
Outcomes of Robotic Total Hip Arthroplasty
An observational study of Osteoarthritis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The objectives of this study are to evaluate the clinical value of robotic-assisted total hip arthroplasty with respect to acetabular cup implantation, and to document the long-term clinical outcome of patients with Total Hip Arthroplasty (THA). Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2023
- Phase
- Observational
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults requiring a total hip arthroplasty procedure.
Who may be able to join
- Male or female
- 20 to 75 years of age
- Subjects requiring primary total hip replacement
- Contralateral hip should be relatively free from arthritis for comparison purposes, specifically with less than a grade of 2 on the Kellgren-Lawrence Scale.
- Subjects diagnosed with osteoarthritis or traumatic arthritis
- Subjects with avascular necrosis
- Subjects who demonstrate the ability to return for follow-up for the next 10 years
Who cannot join
- Subjects with difficulty understanding protocol for any reason
- Subjects with a limited life span
- Subjects with inflammatory hip disease, previous joint infection, or those requiring hip revision surgery
- Female subjects who are pregnant, or who plan to get pregnant while enrolled in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Outcomes of Robotic Total Hip Arthroplasty: A Prospective Study
The objectives of this study are to evaluate the clinical value of robotic-assisted total hip arthroplasty with respect to acetabular cup implantation, and to document the long-term clinical outcome of patients with Total Hip Arthroplasty (THA). IRB approval will be obtained at every study site to evaluate the basic clinical outcomes and post-operative component placement accuracy of each MAKO® THA patient.
The hypothesis is that robotic preparation of the acetabulum will significantly reduce the variability and inaccuracy in the component alignment parameters that lead to post-operative complications, including implant failure.
- Conditions
- Osteoarthritis
- Keywords
- Robotic, Arthroplasty, Total Hip Arthroplasty, Cup Positioning, Outcomes
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Phase II | An evaluation of long-term outcomes, patient reported outcomes, and radiographic analysis will be conducted prospectively on 500 patients | |
| Phase I | An analysis of post-operative component positioning will be evaluated for 500 patients, retrospectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship of Components
Defined as implant remaining in subject.
Measured: 10 Years
Adverse Events
Protocol deviations, complications, "lost to follow-up"
Measured: 10 Years
Secondary outcomes (1)
Retrieval Analysis of implants from revision surgery
When possible, analysis of the THR components that are removed at revision surgery will be anlaysed for signs of component impingment or signs of damage related to component position. These observations will be correlated to the clinical reason for revision.
Measured: Up to 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Why it stopped: No patients will be recruited at Massachsetts General hospital. IRB approval changed to core center.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MAKO Surgical Corp.
- Responsible party
- Principal investigator, Charles R. Bragdon, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672320
- Sponsor's protocol ID
- 2012P000809
- Status last verified
- Nov 2013
- First submitted
- 10 Aug 2012
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Robotic Total Hip Arthroplasty: A Prospective Study
- ClinicalTrials.gov ID
- NCT01672320
- Acronym / sponsor ID
- 2012P000809
- Conditions
- Osteoarthritis
- Keywords
- Robotic, Arthroplasty, Total Hip Arthroplasty, Cup Positioning, Outcomes
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients will be recruited at Massachsetts General hospital. IRB approval changed to core center.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- MAKO Surgical Corp.
- Study start
- Jan 2013
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 24 Aug 2012 (estimated)
- 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 objectives of this study are to evaluate the clinical value of robotic-assisted total hip arthroplasty with respect to acetabular cup implantation, and to document the long-term clinical outcome of patients with Total Hip Arthroplasty (THA). IRB approval will be obtained at every study site to evaluate the basic clinical outcomes and post-operative component placement accuracy of each MAKO® THA patient.
The hypothesis is that robotic preparation of the acetabulum will significantly reduce the variability and inaccuracy in the component alignment parameters that lead to post-operative complications, including implant failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase II | – | –An evaluation of long-term outcomes, patient reported outcomes, and radiographic analysis will be conducted prospectively on 500 patients |
| Phase I | – | –An analysis of post-operative component positioning will be evaluated for 500 patients, retrospectively. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults requiring a total hip arthroplasty procedure.
Key inclusion criteria (7 listed)
- Male or female
- 20 to 75 years of age
- Subjects requiring primary total hip replacement
- Contralateral hip should be relatively free from arthritis for comparison purposes, specifically with less than a grade of 2 on the Kellgren-Lawrence Scale.
- Subjects diagnosed with osteoarthritis or traumatic arthritis
Key exclusion criteria (4 listed)
- Subjects with difficulty understanding protocol for any reason
- Subjects with a limited life span
- Subjects with inflammatory hip disease, previous joint infection, or those requiring hip revision surgery
- Female subjects who are pregnant, or who plan to get pregnant while enrolled in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survivorship of Components
Time frame: 10 Years
Defined as implant remaining in subject.
Adverse Events
Time frame: 10 Years
Protocol deviations, complications, "lost to follow-up"
1 secondary outcome
Retrieval Analysis of implants from revision surgery
Time frame: Up to 10 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2013.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Massachusetts General Hospital 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 7 inclusion and 4 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: withdrawn, as of the sponsor's last update on 5 Nov 2013. 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 was withdrawn before enrolling participants, so there are no results.
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?
Survivorship of Components (time frame: 10 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2013.