MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads (NCT05199870) | Clinical Trial Compass
By InvitationNot Applicable
MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads
United States116 participantsStarted 2026-03-10
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Device safety assessed through the frequency and incidence of revisions, complications, and Adverse Events.