MDR - G7 Neutral en G7 Freedom Constrained Neutral Acetabular Liners
Post-market klinische follow-upstudie van de G7 Freedom Constrained Neutral Liner en G7 Neutral +5 mm Liner bij primaire en revisie totale heupartroplastiek (implantaten en instrumentatie)
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 5 years follow-up. Since G7 Acetabular Cup System has only been on the market since 2015, a prospective follow-up will be necessary to obtain data for the 5 year post-surgery time-point for each patient.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 5 years follow-up. Since G7 Acetabular Cup System has only been on the market since 2015, a prospective follow-up will be necessary to obtain data for the 5 year post-surgery time-point for each patient.
The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified.
The secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (PROMs).
Studietype
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
This will include a consecutive series of subjects implanted with the G7 Freedom Constrained Liners in primary and revision total hip arthroplasty according to the approved
Beschrijving
Inclusion Criteria:
- Patient must be 18 years of age or older and skeletally mature
- Patient must be willing and able to sign Institution Review Board (IRB) approved informed consent
- Noninflammatory degenerative joint disease including:
- Osteoarthritis
- 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 by other -techniques
- High risk of dislocation due to:
- History of prior dislocation
- Bone loss
- Joint or soft tissue laxity
- Neuromuscular disease
- Intraoperative instability
- Revision procedures where other treatment or devices have failed
Exclusion Criteria:
- Off-label use
- Infection and/or distant foci of infections which may spread to the implant site
- Sepsis
- Osteomyelitis
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- Osteoporosis
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy or neuromuscular disease
- Patient is known to be pregnant or nursing
- Patient is a prisoner
- Patient is a known alcohol or drug abuser
- Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
- Patient is unwilling to sign an informed consent
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
G7 Freedom Constrained Liners
Patients that have been implanted with a G7 Freedom Constrained liner to repair hip malfunction or disease. |
Patients that have been implanted with the G7 Freedom Constrained Liners to repair hip malfunction and/or disease. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Device Safety assessed through the frequency and incidence of revisions, complications and adverse events
Tijdsspanne: Out to five years
|
The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified. |
Out to five years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Device Performance and Benefits evaluated through the Oxford Hip Score
Tijdsspanne: Out to five years
|
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. |
Out to five years
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Erin Osborn, Zimmer Biomet
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MDRG2017-89MS-53H
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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