MDR - Inserti acetabolari neutri G7 Neutral e G7 Freedom Constrained
Studio di follow-up clinico post-vendita dell'inserto neutro G7 Freedom Constrained e dell'inserto neutro +5 mm G7 nell'artroplastica totale dell'anca primaria e di revisione (impianti e strumentario)
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Device Safety assessed through the frequency and incidence of revisions, complications and adverse events
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Device Performance and Benefits evaluated through the Oxford Hip Score
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Erin Osborn, Zimmer Biomet
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MDRG2017-89MS-53H
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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