MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads
Enrolling by invitationNCT05199870
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- 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
- Conditions
- Hip Arthritis
- Hip Disease
- Hip Fractures
- Hip Injuries
- Hip Pain Chronic
- Interventions
- Device: RingLoc Bipolar Acetabular Cup
- Device: Endo II Femoral Head
- Sponsor
- Zimmer Biomet
- Start date
- 2026-03-10
- Primary completion
- 2027-03
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05199870