Enrolling by invitation NCT05199870

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

— Observational Hip Arthritis Hip Disease Hip Fractures Hip Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: RingLoc Bipolar Acetabular Cup, Endo II Femoral Head.
Who it may be relevant to: Registry conditions: Hip Arthritis, Hip Disease, Hip Fractures, Hip Injuries. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

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).

Detailed description

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).

Interventions

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

Primary outcome measures

Device safety assessed through the frequency and incidence of revisions, complications, and Adverse Events. [Time frame: Greater than or equal to 8 years.]

Secondary outcome measures (1)

Device Performance and Benefits evaluated through the Oxford Hip Score and Patient Assessment. [Time frame: Greater than or equal to 8 years.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

United States · 1 center

Inova Fairfax Hospital — Falls Church

Identifiers

NCT: NCT05199870 · MDRG2017-89MS-43H

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗