Persona Ti-Nidium Klinisk oppfølging etter markedet (TKA)
Persona® Ti-Nidium® Personalized Total Knee System En post-markeds klinisk oppfølgingsstudie for å gi data om sikkerhet, ytelse og kliniske fordeler ved bruk av Persona Ti-Nidium Total Knee System og instrumentering
The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The study design is a prospective, multicenter data collection model of the 510(k) cleared Persona Ti-Nidium Total Knee System. The study will require each site to obtain institutional review board (IRB) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. Investigators will collect clinical data for a required 10 years. Follow-up clinical visits include Early Post-op, 6 months, 1 year, 2, 3, 5, 7 and 10 years post-operatively.
The objective of this study is to evaluate clinical performance, benefits and safety of the Persona Ti-Nidium implant in total knee arthroplasty.
Specific assessments include:
- Confirming the long-term safety, performance and clinical benefits of the Persona Ti-Nidium total knee system and instrumentation in primary and revision TKA.
- Verifying that, under normal use, the performance and clinical benefits of this device and its instrumentation conform to those intended by the manufacturer by recording patient-reported clinical outcomes measures (PROMs) and radiographic outcomes (if available).
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Colorado
-
Parker, Colorado, Forente stater, 80134
- Denver Hip & Knee, Inc.
-
-
Maryland
-
Hyattsville, Maryland, Forente stater, 20782
- MedStar Health Research Institute
-
-
Mississippi
-
Jackson, Mississippi, Forente stater, 39202
- Mississippi Sports Medicine and Orthopaedic Center
-
-
New Mexico
-
Albuquerque, New Mexico, Forente stater, 87110
- New Mexico Orthopaedic Associates
-
-
North Carolina
-
Durham, North Carolina, Forente stater, 27708
- Duke University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19107
- Rothman Orthopaedic Institute
-
-
South Dakota
-
Rapid City, South Dakota, Forente stater, 57701
- Monument Health Rapid City Hospital, Inc.
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patient is of legal age and skeletally mature
- Patient is willing and able to provide written Informed Consent by signing and dating the IRB-approved Informed Consent document
- Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
- Patient qualifies for total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Ti-Nidium Knee System and Vivacit-E polyethylene articulating surface
- Independent of study participation, patient is a candidate for the commercially available Persona Ti-Nidium Knee and Vivacit-E polyethylene articulating surface, implanted in accordance with product labeling
Study Device Inclusion Criteria:
The Persona Ti-Nidium Total Knee is intended for patients with severe pain and disability due to the following:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
Exclusion Criteria:
- Patient is unwilling to sign the Informed Consent
- Patient is currently participating in any other surgical intervention or pain management study
- Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
- Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
- Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study
- Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
Study Device Exclusion Criteria
- Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint
- Insufficient bone stock on femoral or tibial surfaces
- Skeletal immaturity
- Neuropathic arthropathy
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
- A stable, painless arthrodesis in a satisfactory functional position
- Severe instability secondary to the absence of collateral ligament integrity
- Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
- The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with medial collateral ligament (MCL) insufficiency
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Persona Ti-Nidium
Primary total knee arthroplasty subjects that receive the Zimmer Biomet Persona Ti-Nidium Total Knee System |
Primary Knee Total Arthroplasty |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Oxford Knee Score (OKS)
Tidsramme: 10 years
|
A patient reported functional outcome score for knee arthroplasty. This score ranges from 0-48, with higher scores indicating a better outcome. |
10 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Knee Society Score (KSS) Expectations (pre and post op)
Tidsramme: 10 years
|
This is a 3 question form regarding a patient's expectations of the total knee replacement. The pre-op form assesses the patient's expectations of the knee replacement, and the post-op form addresses how the replacement is meeting said expectations. The score ranges from 3-15, with higher scores indicating a better outcome. |
10 years
|
|
EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure
Tidsramme: 10 years
|
A questionnaire completed by the patient and assesses his/her general health status. This score ranges from -0.573 to 1, with higher recorded scores indicating better overall health. |
10 years
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Hillary Overholser, Zimmer Biomet Assoc Director
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CMG2020-05K
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .