Osteoarthritis, HipNCT05497206
ROSA® Hip System THA PMCF
An observational study of Osteoarthritis, Hip and Avascular Necrosis of Hip, run by Zimmer Biomet at 2 sites in United States.
Trial summary
This study is a Prospective, Multicenter, Single-Arm, Cohort post-market study to evaluate the accuracy of acetabular implant position using the robotic-arm surgical assistant (ROSA® Hip System). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Hip, Avascular Necrosis of Hip
- What is being tested?
- One of the following hip implants may be used within this arm of the study: G7 Acetabular System, Taperloc Complete System, Avenir and Avenir Complete Systems, and Echo Bi-Metric System
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jun 2024to 20 Dec 2024
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Operative primary total hip arthroplasty candidates
Who may be able to join
- Age 18 - 80 years
- Body mass index ≤40 (BMI = kg/m2)
- Patient is willing and able to provide informed consent
- Patient qualifies for primary THA, via an anterior approach, due to osteoarthritis or avascular necrosis of the hip based on Investigator's clinical judgment
- Independent of study participation, patient is a candidate and meets the indications and none of the contraindications for use with the ROSA Hip System
Who cannot join
- Has undergone an orthopaedic procedure of the spine or lower extremity, or is currently participating in a pain management clinical study of any joint, within the last 6 months or planned within the next 6 months
- Patients receiving simultaneous bilateral hip arthroplasties are excluded from participation in this study; as well as any participants with staged bilateral arthroplasties within 6 months of each other
- Active infection, sepsis, osteomyelitis
- Patient is at a high risk for dislocation including those with long-segment spinal fusions (>3 levels) and neuromuscular disorders
- Inflammatory (rheumatoid or psoriatic arthritis) or post-traumatic arthropathy, or any other degenerative joint disease not consistent with osteoarthritis
- Would, in the Investigator's opinion, be unwilling or unable to comply with the postoperative follow-up schedule
- Patient is considered a member of a vulnerable population (pregnant, prisoner, mentally incompetent, etc.)
- Previous hardware in the proximal femur or acetabulum from a prior orthopaedic procedure
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Mosaic Life Care
Saint Joseph, Missouri, 64507
About this study
Official title: A Post-Market, Multi-Center, Single Arm Trial on Robotic Instrumentation (ROSA® Hip System) in Patients Undergoing Direct Anterior Total Hip Arthroplasty With Fluoroscopic Guidance
This study is a Prospective, Multicenter, Single-Arm, Cohort post-market study to evaluate the accuracy of acetabular implant position using the robotic-arm surgical assistant (ROSA® Hip System).
Read the detailed description
Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for participation in the study, and will be pre-screened for participation in the informed consent process.
The primary objective of this study is to assess the accuracy of acetabular implant position by evaluating the percentage of participants who are within the range of the Callanan safe zones for Acetabular Inclination (30 - 45 degrees). A patient is considered a success if their intra-operative and/or post-operative full pelvis fluoroscopic or radiographic images show the postoperative acetabular inclination to be within this safe zone range.
Secondary Objectives include the evaluation of safety and efficacy of this system and will include the assessment of common adverse events, physical exam findings, radiologic results, and patient reported outcome measures.
Data collection will occur at the following intervals: Pre-operative, Operative, 3-months, 1-year, and 2-years. Enrollment for the study is anticipated to last approximately 18 months. Allowing for 24 months of follow-up, the total estimated study time to final-patient final-visit will be approximately 42 months.
- Conditions
- Osteoarthritis, Hip, Avascular Necrosis of Hip
- Being tested
- One of the following hip implants may be used within this arm of the study: G7 Acetabular System, Taperloc Complete System, Avenir and Avenir Complete Systems, and Echo Bi-Metric System
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One of the following hip implants may be used within this arm of the study: G7 Acetabular System, Taperloc Complete System, Avenir and Avenir Complete Systems, and Echo Bi-Metric SystemDevice
Total Hip Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Robotic-Assisted THA | Consecutive participants will receive THA via the ROSA Hip System. Receives: Device: One of the following hip implants may be used within this arm of the study: G7 Acetabular System, Taperloc Complete System, Avenir and Avenir Complete Systems, and Echo Bi-Metric System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of implant position
To evaluate the accuracy of acetabular implant position using the robotic-arm surgical assistant (ROSA® Hip System) (rTHA). Accuracy of acetabular implant position will be assessed by evaluating the percentage of participants who are within the range of the Callanan safe zones for Acetabular Inclination (30 - 45 degrees). A patient is considered a success if their intra-operative and/or post-operative full pelvis fluoroscopic or radiographic images show the postoperative acetabular inclination to be within this safe zone range.
Measured: 90 days
Secondary outcomes (10)
Evaluation of Patient safety
Frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.
Measured: 24 months
Patient Reported Outcome Measure (Oxford Hip Score)
A questionnaire completed by the patient consisting of twelve questions that utilize a 5-point Likert scoring system (0 - 4) resulting in a score ranging from 0 (worst) to 48 (best).
Measured: 24 months
Numeric Pain Rating Scale (NPRS)
An 11-point NPRS is a patient self-completed reported outcome and will be used to assess the current level of pain for the affected hip. On this scale, 0 will indicate no pain and 10 will indicate the worst pain imaginable
Measured: 24 months
Subject Satisfaction
A questionnaire consisting of a single satisfaction question in regard to the subjects hip replacement. Answers will include the following: Very Dissatisfied, Dissatisfied, Neutral, Satisfied, Very Satisfied.
Measured: 24 months
Clinical performance will be assessed with evaluation of range of motion.
Range of motion will be evaluated in a supine position and assess flexion, abduction (in flexion), adduction (in flexion), external rotation (in extension), and internal rotation (in extension). Range of motion will be measured in degrees.
Measured: 24 months
Clinical performance will be assessed with evaluation of stability using the Trendelenburg test.
The test is negative when the hip of the leg that is lifted, will also go up i.e., hiking of hip or the pelvis tilts upwards. The test is positive, when there is a drop of the hip or a downwards tilt of the pelvis. The test is level when the subject presents normal gait and adequate pelvic stability. If the subject is unable to perform the test, this will be noted "unable to perform test".
Measured: 24 months
Clinical performance will be assessed by testing leg length discrepancy.
This will be assessed by (3) categories (legs equal, right short, left short) and discrepancies will be measured in mm or cm.
Measured: 24 months
Physician Radiographic Assessment of Acetabular Cup
Records acetabular cup inclination (degrees), acetabular cup anteversion (degrees)
Measured: 2 Years
Physician Radiographic Assessment of Femoral and Global Offset and Leg Length Discrepancy
Records femoral offset (mm), global offset (mm), leg length (mm)
Measured: 2 Years
Physician Radiographic Assessment of Significant Radiographic Findings
Records evidence of fracture (y/n), evidence of acetabular migration (y/n), evidence of heterotopic ossification (y/n), or other significant radiographic findings (including the zone it occurs in)
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start5 Jun 2024
- Primary completion12 Dec 2024
- Study completion20 Dec 2024
Why it stopped: The data needed for regulatory submissions based on the current pace of the study, will not be available in the foreseeable future.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hillary Overholser, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497206
- Sponsor's protocol ID
- CMU2021-26TDS
- Status last verified
- Oct 2026
- First submitted
- 23 Feb 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market, Multi-Center, Single Arm Trial on Robotic Instrumentation (ROSA® Hip System) in Patients Undergoing Direct Anterior Total Hip Arthroplasty With Fluoroscopic Guidance
- ClinicalTrials.gov ID
- NCT05497206
- Acronym / sponsor ID
- CMU2021-26TDS
- Conditions
- Osteoarthritis, Hip, Avascular Necrosis of Hip
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The data needed for regulatory submissions based on the current pace of the study, will not be available in the foreseeable future.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 11 Aug 2022 (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.
This study is a Prospective, Multicenter, Single-Arm, Cohort post-market study to evaluate the accuracy of acetabular implant position using the robotic-arm surgical assistant (ROSA® Hip System).
Detailed description
Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for participation in the study, and will be pre-screened for participation in the informed consent process.
The primary objective of this study is to assess the accuracy of acetabular implant position by evaluating the percentage of participants who are within the range of the Callanan safe zones for Acetabular Inclination (30 - 45 degrees). A patient is considered a success if their intra-operative and/or post-operative full pelvis fluoroscopic or radiographic images show the postoperative acetabular inclination to be within this safe zone range.
Secondary Objectives include the evaluation of safety and efficacy of this system and will include the assessment of common adverse events, physical exam findings, radiologic results, and patient reported outcome measures.
Data collection will occur at the following intervals: Pre-operative, Operative, 3-months, 1-year, and 2-years. Enrollment for the study is anticipated to last approximately 18 months. Allowing for 24 months of follow-up, the total estimated study time to final-patient final-visit will be approximately 42 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic-Assisted THA | – | Device: One of the following hip implants may be used within this arm of the study: G7 Acetabular System, Taperloc Complete System, Avenir and Avenir Complete Systems, and Echo Bi-Metric SystemConsecutive participants will receive THA via the ROSA Hip System. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Operative primary total hip arthroplasty candidates
Key inclusion criteria (5 listed)
- Age 18 - 80 years
- Body mass index ≤40 (BMI = kg/m2)
- Patient is willing and able to provide informed consent
- Patient qualifies for primary THA, via an anterior approach, due to osteoarthritis or avascular necrosis of the hip based on Investigator's clinical judgment
- Independent of study participation, patient is a candidate and meets the indications and none of the contraindications for use with the ROSA Hip System
Key exclusion criteria (8 listed)
- Has undergone an orthopaedic procedure of the spine or lower extremity, or is currently participating in a pain management clinical study of any joint, within the last 6 months or planned within the next 6 months
- Patients receiving simultaneous bilateral hip arthroplasties are excluded from participation in this study; as well as any participants with staged bilateral arthroplasties within 6 months of each other
- Active infection, sepsis, osteomyelitis
- Patient is at a high risk for dislocation including those with long-segment spinal fusions (>3 levels) and neuromuscular disorders
- Inflammatory (rheumatoid or psoriatic arthritis) or post-traumatic arthropathy, or any other degenerative joint disease not consistent with osteoarthritis
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 |
|---|---|---|
| One of the following hip implants may be used within this arm of the study: G7 Acetabular System, Taperloc Complete System, Avenir and Avenir Complete Systems, and Echo Bi-Metric SystemTotal Hip Arthroplasty | Device | Robotic-Assisted THA |
Primary outcome
Accuracy of implant position
Time frame: 90 days
To evaluate the accuracy of acetabular implant position using the robotic-arm surgical assistant (ROSA® Hip System) (rTHA). Accuracy of acetabular implant position will be assessed by evaluating the percentage of participants who are within the range of the Callanan safe zones for Acetabular Inclination (30 - 45 degrees). A patient is considered a success if their intra-operative and/or post-operative full pelvis fluoroscopic or radiographic images show the postoperative acetabular inclination to be within this safe zone range.
10 secondary outcomes
Evaluation of Patient safety
Time frame: 24 months
Patient Reported Outcome Measure (Oxford Hip Score)
Time frame: 24 months
Numeric Pain Rating Scale (NPRS)
Time frame: 24 months
Subject Satisfaction
Time frame: 24 months
Clinical performance will be assessed with evaluation of range of motion.
Time frame: 24 months
Clinical performance will be assessed with evaluation of stability using the Trendelenburg test.
Time frame: 24 months
Clinical performance will be assessed by testing leg length discrepancy.
Time frame: 24 months
Physician Radiographic Assessment of Acetabular Cup
Time frame: 2 Years
Physician Radiographic Assessment of Femoral and Global Offset and Leg Length Discrepancy
Time frame: 2 Years
Physician Radiographic Assessment of Significant Radiographic Findings
Time frame: 2 Years
Results and safety
The study was stopped early (reason given: The data needed for regulatory submissions based on the current pace of the study, will not be available in the foreseeable future.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- 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.
Hillary Overholser study director
Zimmer Biomet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip and Avascular Necrosis of Hip, run by Zimmer Biomet at 2 sites 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 stopped early (reason given: The data needed for regulatory submissions based on the current pace of the study, will not be available in the foreseeable future.). Results are not available in the source record.
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 implant position (time frame: 90 days). 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 13 Oct 2026.