Status:
NOT_YET_RECRUITING
MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads
Lead Sponsor:
Zimmer Biomet
Conditions:
Hip Arthritis
Hip Disease
Eligibility:
All Genders
18+ years
Brief 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 Aceta...
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 Aceta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 3 2030
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT05199870
Start Date
November 1 2025
End Date
September 3 2030
Last Update
November 7 2025
Active Locations (1)
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1
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042