Z1 Hip System: Post-Market Clinical Follow Up Study
A legfontosabb adatok
- Ki végzi
- Zimmer Biomet
- Hol
- Alexandria, Charlotte, Cleveland, Platte City és Portland (Egyesült Államok)Mind a 5 helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 300 fő, tervezett
- Kezdés
- 2025. okt. 13.
- Várható befejezés
- 2031. aug.
- A vizsgálat típusa
- Megfigyeléses, 2 csoport
- A vizsgált kezelések
- Z1 Femoral Hip System
- A regiszteradat frissítve
- 2026. október 16.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for adults who need a first hip replacement, total or partial (hemi-arthroplasty), with the Z1 Femoral Hip System.
- Életkor
- 18 years and older, with a fully grown skeleton.
- Nem
- All sexes.
- A betegség stádiuma
- Needs a first total or partial hip replacement because of at least one of these: advanced joint wear from degenerative, post-traumatic or rheumatic disease; a recent injury fracture of the femoral head or neck; or avascular necrosis (bone death) of the femoral head.
- Korábbi kezelés
- People who need a revision (a repeat hip replacement) cannot join.
A részvétel fő kizáró okai
- Any infection, local or throughout the body
- Severe muscle, nerve or blood vessel disease that puts the leg at risk
- Not enough bone, muscle or ligament to hold the implant
- Allergy to the implant material, especially metals such as cobalt, chromium or nickel
- Local bone tumors or cysts, known pregnancy, prisoners, known substance abuse
A regiszter feltételei, szó szerint
Mind a 14 feltétel megnézéseKevesebb
Ki vehet részt
- Patient is at least 18 years old and skeletally mature
- Patient is physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol, including all scheduled study evaluations
- Patient, or the patient's legally authorized representative, is willing and able to participate in the Informed Consent process and provide their consent
- Independent of study participation, patient is a candidate and qualifies for primary total hip or hemi-arthroplasty based on physical exam and medical history including at least one of the following:; Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases; Acute traumatic fracture of the femoral head or neck; Avascular necrosis (AVN) of the femoral head
Ki nem vehet részt
- Lack of bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible
- Any concomitant diseases that can jeopardize the functioning and the success of the implant
- Acute, chronic, local, or systemic infection(s)
- Severe muscular, neural, or vascular diseases that endanger the limb(s) involved
- Allergy to the implanted material, especially to metal (e.g. cobalt, chromium, nickel, etc.)
- Patient has any condition that would, in the Investigator's opinion, place the patient at undue risk or interfere with the study
- Revision arthroplasty
- Total or partial absence of the muscular or ligamentous apparatus
- Local bone tumors and/or cysts
- Any vulnerable subject:; a prisoner; a patient known to be pregnant; mentally incompetent or unable to understand what participation in the study entails; a known substance abuser
Helyszínek itt: Egyesült Államok
- Anderson Orthopaedic/Anderson Orthopaedic Research InstituteAlexandria, Egyesült ÁllamokContact: Robert HopperRésztvevőt keres
- OrthoCarolina/OrthoCarolina Research InstituteCharlotte, Egyesült ÁllamokContact: Alexis ReadyRésztvevőt keres
- Cleveland ClinicCleveland, Egyesült ÁllamokContact: Laura StiegelRésztvevőt keres
- Mokan Orthopedic Research and ConsultingPlatte City, Egyesült ÁllamokContact: Mandi PetersonRésztvevőt keres
- Orthopedic + Fracture SpecialistsPortland, Egyesült ÁllamokContact: Jacquline SheltonRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
The objectives of this study are to confirm the early to mid- term safety, performance, and clinical benefits of the Z1 Femoral Hip System in hemi- and primary total hip arthroplasty.
A teljes eredeti leírásKevesebb
Cohort 0 The primary endpoint is defined by the survival of the implant system at 2 years, which is based on the absence of removal of the study device and will be evaluated using a one-sample proportion as well as using the Kaplan Meier method. The safety of the system will additionally be assessed by monitoring the frequency and incidence of adverse events, including relation to implant, instrumentation, and/or procedure.
The secondary endpoints are defined by the functional performance and clinical benefits of the study device and are assessed by patient-reported clinical outcomes measures (PROMs)(Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)).
Cohort 1 The primary performance endpoint is the assessment of the HOOS JR, specifically the within-patient change from baseline to 2-years post-op. The mean change from baseline will be compared against a minimal clinically important difference (MCID) of 9.46 points.
The key secondary safety endpoint is defined by the survival of the implant system at 2 years, which is based on the absence of removal of the study device and will be evaluated using a one-sample proportion as well as using the Kaplan Meier method. The safety of the system will additionally be assessed by monitoring the frequency and incidence of adverse events, including relation to implant, instrumentation, and/or procedure.
Exploratory outcomes include:
* EuroQol 5 Dimensions (EQ-5D) * Patient Satisfaction * Radiographic outcomes, where available
A vizsgálat 2 csoportja
- Cohort 0
Subjects implanted with the Z1 Femoral Hip System manufactured by Zimmer, Inc.: AristoTech (Luckenwalde, Germany)
Kezelés: Z1 Femoral Hip System
- Cohort 1
Subjects implanted with the Z1 Femoral Hip System manufactured by Zimmer, Inc. (Warsaw, IN, USA)
Kezelés: Z1 Femoral Hip System
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Multicenter, Post-Market Clinical Follow-up Study of the Z1 Femoral Hip System
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- A regiszteradat frissítve
- 2026. október 16.