Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry
A legfontosabb adatok
- Hol
- Bangalore és New Delhi (India)Mind a 2 helyszín megnézése
Helyszínek itt: India
- Sri Shankara Cancer Hospital and Research CenterBangalore, IndiaContact: Vinay V Kumar, MDRésztvevőt keres
- All India Institute of Medical Sciences(AIIMS)New Delhi, IndiaContact: Viola GrünenfelderNo longer taking part
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 orvosomnakA vizsgálat adatai
- Ki végzi
- AO Innovation Translation Center
- Azonosító
- NCT03991728
- A regiszteradat frissítve
- 2026. szeptember 16.
- Eredeti leírás
Prospective data will be collected in approximately 200 patients treated with an TMJ replacement. Patients will be followed up according to the standard (routine) for up to 5 years after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s and anticipated or procedure-related adverse events (i.e. complications).A teljes eredeti leírásKevesebb
International, Multicenter, Prospective Registry to Collect Data of Patients Treated With Alloplastic Total Temporomandibular Joint (TMJ) Replacements
Prospective data will be collected in approximately 200 patients treated with an TMJ replacement. Patients will be followed up according to the standard (routine) for up to 5 years after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s and anticipated or procedure-related adverse events (i.e. complications).
This registry is designed to be able to assess the number of patients who refuse alloplastic total TMJ replacement. Therefore, the participating sites are asked to register all cases of refused TMJ replacements too.
Bevonási feltételek: Age 18 years and or older; Patients requiring alloplastic total TMJ replacement; Informed consent obtained, i.e.:; Ability to understand the content of the patient information/informed consent form (ICF); Willingness and ability to participate in the registry according to the Registry Plan (RP); Signed and dated ethics committee (EC) / Institutional review board (IRB) approved written informed consent.
Kizáró feltételek: Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study; Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment; Pregnancy or women planning to conceive within the study period.