Hip ArthritisNCT05199870
MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads
An observational study of Hip Arthritis and Hip Disease, run by Zimmer Biomet at 1 site in United States.
Trial summary
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup and the Endo II Femoral Head when used for hip hemiarthroplasty (implants and instrumentation). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthritis, Hip Disease, Hip Fractures
- What is being tested?
- RingLoc Bipolar Acetabular Cup and Endo II Femoral Head
- Type of treatment
- Medical device
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: A consecutive series of patients implanted with the RingLoc Bipolar acetabular cup or the Endo II Femoral Head.
Who may be able to join
- Patient must be 18 years of age or older and skeletally mature
- Patient must have undergone hip hemiarthroplasty surgery with the RingLoc Bipolar Acetabular Cup or Endo II Femoral Head for a cleared indication, greater than or equal to eight years previous to the date of study consent. Cleared indications for the RingLoc Bipolar and Endo II Heads include the following:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Who cannot join
- Any medical diagnosis present at the time of surgery that, at the Investigator's discretion, could compromise the implant's survivability
- Off-label use or not according to the approved instructions for use (IFU) of study devices
- Revision procedures where other treatment or devices have failed
- Uncooperative patient or patient with neurologic disorders who is incapable of following directions
- Patient has a psychiatric illness or
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Inova Fairfax Hospital
Falls Church, Virginia, 22042
About this study
Official title: Post-Market Clinical Follow-Up Study to Provide Safety, Performance and Clinical Benefits Data of the RingLoc Bipolar Acetabular Cup or Endo II Heads (Implants and Instrumentation) in Hip Hemiarthroplasty - A Retrospective Enrollment/Prospective Follow-Up Consecutive Series Study
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup and the Endo II Femoral Head when used for hip hemiarthroplasty (implants and instrumentation).
Read the detailed description
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup and the Endo II Femoral Head when used for hip hemiarthroplasty (implants and instrumentation).
The primary objective of this study is the assessment of safety by analyzing implant survivorship at the longest follow-up timepoint available, greater than or equal to eight years post-implantation. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to implant, instrumentation and/or procedure should be specified.
The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs).
- Conditions
- Hip Arthritis, Hip Disease, Hip Fractures, Hip Injuries, Hip Pain Chronic
- Being tested
- RingLoc Bipolar Acetabular Cup, Endo II Femoral Head
- Medical subject headings
- Hip Fractures, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RingLoc Bipolar Acetabular CupDevice
Patients that have been implanted with a RingLoc Bipolar acetabular cup.
Endo II Femoral HeadDevice
Subjects that have been implanted with an Endo II Femoral Head
| Study group | Role | What they receive |
|---|---|---|
| RingLoc Bipolar Acetabular Cup | Patients that have been implanted with the RingLoc Bipolar acetabular cup to repair hip malfunction/disease/injury. Receives: Device: RingLoc Bipolar Acetabular Cup | |
| Endo II Femoral Heads | Subjects who were implanted with the Endo II Femoral head during hemiarthroplasty Receives: Device: Endo II Femoral Head |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device safety assessed through the frequency and incidence of revisions, complications, and Adverse Events.
The primary objective of this study is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and Adverse Events. Relation of the events to either implant or instrumentation will be specified.
Measured: Greater than or equal to 8 years.
Secondary outcomes (1)
Device Performance and Benefits evaluated through the Oxford Hip Score and Patient Assessment.
The OHS is a patient-completed, 12-question evaluation. Each item is scored from 1 to 5, with 1 representing best outcome/least symptoms and 5 representing worst outcome/most symptoms. The Patient Assessment is patient completed and a 4-question evaluation.
Measured: Greater than or equal to 8 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start10 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthritisStudies 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
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lynsey Boyle, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199870
- Sponsor's protocol ID
- MDRG2017-89MS-43H
- Status last verified
- Mar 2026
- First submitted
- 5 Jan 2022
- Last updated
- 19 Mar 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-Up Study to Provide Safety, Performance and Clinical Benefits Data of the RingLoc Bipolar Acetabular Cup or Endo II Heads (Implants and Instrumentation) in Hip Hemiarthroplasty - A Retrospective Enrollment/Prospective Follow-Up Consecutive Series Study
- ClinicalTrials.gov ID
- NCT05199870
- Acronym / sponsor ID
- MDRG2017-89MS-43H
- Conditions
- Hip Arthritis, Hip Disease, Hip Fractures, Hip Injuries, Hip Pain Chronic
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Jan 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.
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup and the Endo II Femoral Head when used for hip hemiarthroplasty (implants and instrumentation).
Detailed description
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup and the Endo II Femoral Head when used for hip hemiarthroplasty (implants and instrumentation).
The primary objective of this study is the assessment of safety by analyzing implant survivorship at the longest follow-up timepoint available, greater than or equal to eight years post-implantation. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to implant, instrumentation and/or procedure should be specified.
The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RingLoc Bipolar Acetabular Cup | – | Device: RingLoc Bipolar Acetabular CupPatients that have been implanted with the RingLoc Bipolar acetabular cup to repair hip malfunction/disease/injury. |
| Endo II Femoral Heads | – | Device: Endo II Femoral HeadSubjects who were implanted with the Endo II Femoral head during hemiarthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A consecutive series of patients implanted with the RingLoc Bipolar acetabular cup or the Endo II Femoral Head.
Key inclusion criteria (6 listed)
- Patient must be 18 years of age or older and skeletally mature
- Patient must have undergone hip hemiarthroplasty surgery with the RingLoc Bipolar Acetabular Cup or Endo II Femoral Head for a cleared indication, greater than or equal to eight years previous to the date of study consent. Cleared indications for the RingLoc Bipolar and Endo II Heads include the following:
Key exclusion criteria (5 listed)
- Any medical diagnosis present at the time of surgery that, at the Investigator's discretion, could compromise the implant's survivability
- Off-label use or not according to the approved instructions for use (IFU) of study devices
- Revision procedures where other treatment or devices have failed
- Uncooperative patient or patient with neurologic disorders who is incapable of following directions
- Patient has a psychiatric illness or
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 |
|---|---|---|
| RingLoc Bipolar Acetabular CupPatients that have been implanted with a RingLoc Bipolar acetabular cup. | Device | RingLoc Bipolar Acetabular Cup |
| Endo II Femoral HeadSubjects that have been implanted with an Endo II Femoral Head | Device | Endo II Femoral Heads |
Primary outcome
Device safety assessed through the frequency and incidence of revisions, complications, and Adverse Events.
Time frame: Greater than or equal to 8 years.
The primary objective of this study is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and Adverse Events. Relation of the events to either implant or instrumentation will be specified.
1 secondary outcome
Device Performance and Benefits evaluated through the Oxford Hip Score and Patient Assessment.
Time frame: Greater than or equal to 8 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 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.
Lynsey Boyle study director
Zimmer Biomet
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 Hip Arthritis and Hip Disease, run by Zimmer Biomet 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 6 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 19 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Device safety assessed through the frequency and incidence of revisions, complications, and Adverse Events. (time frame: Greater than or equal to 8 years.). 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 19 Mar 2026.