MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads

N/ANot Yet RecruitingNCT05199870

Zimmer Biomet116 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

116

Conditions

Hip Arthritis Hip Disease Hip Fractures Hip Injuries Hip Pain Chronic

Interventions

RingLoc Bipolar Acetabular CupDEVICE

Patients that have been implanted with a RingLoc Bipolar acetabular cup.

Endo II Femoral HeadDEVICE

Subjects that have been implanted with an Endo II Femoral Head

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Inova Fairfax Hospital

Falls Church, Virginia, United States

Outcomes

Primary Outcomes

Device safety assessed through the frequency and incidence of revisions, complications, and Adverse Events.

The primary objective of this study is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and Adverse Events. Relation of the events to either implant or instrumentation will be specified.

Time frame: Greater than or equal to 8 years.

Secondary Outcomes

Device Performance and Benefits evaluated through the Oxford Hip Score and Patient Assessment.

The OHS is a patient-completed, 12-question evaluation. Each item is scored from 1 to 5, with 1 representing best outcome/least symptoms and 5 representing worst outcome/most symptoms. The Patient Assessment is patient completed and a 4-question evaluation.

Time frame: Greater than or equal to 8 years.

Central Contacts

Taylor Rowe

CONTACT

980-259-2813 taylor.rowe@zimmerbiomet.com

Data from ClinicalTrials.gov

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