NCT05199870Enrolling by invitation
MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads
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
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 116 (estimated)
- First submitted
- 5 Jan 2022
- Start date
- 10 Mar 2026
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Zimmer Biomet
- NCT number
- NCT05199870
What you commit to
- Study type: Observational
- Planned participants: 116
- From 10 Mar 2026 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any medical diagnosis present at the time of surgery that, at the Investigator's discretion, could compromise the implant's survivability
Other illness
- Uncooperative patient or patient with neurologic disorders who is incapable of following directions
- Patient has a psychiatric illness or
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Inova Fairfax Hospital Coordinator of this site? Confirm its status | Falls Church | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.