Trials / Enrolling By Invitation
Enrolling By InvitationNCT05199870
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
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 116 (estimated)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RingLoc Bipolar Acetabular Cup | Patients that have been implanted with a RingLoc Bipolar acetabular cup. |
| DEVICE | Endo II Femoral Head | Subjects that have been implanted with an Endo II Femoral Head |
Timeline
- Start date
- 2026-03-10
- Primary completion
- 2027-03-01
- Completion
- 2027-03-01
- First posted
- 2022-01-20
- Last updated
- 2026-03-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05199870. Inclusion in this directory is not an endorsement.