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Résztvevőt keres itt: Egyesült ÁllamokFázis nélkül

Talus Replacement Registry

A legfontosabb adatok

Ki végzi
Kyle Schweser MD
Hol
Columbia (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
50 fő, tervezett
Kezdés
2020. jan. 1.
Várható befejezés
2027. máj. 1.
A vizsgálat típusa
Megfigyeléses
A vizsgált kezelések
  • 3D talar augmentation
A regiszteradat frissítve
2026. április 28.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak

A regiszter feltételei, szó szerint

Mind a 10 feltétel megnézéseKevesebb

Ki vehet részt

  • Subjects age 18 years or above at time of screening
  • Condition satisfies requirement for total talus replacement
  • Able to consent and participate in the study
  • No previous history of septic arthritis involving the hindfoot/midfoot
  • Previous ability to ambulate

Ki nem vehet részt

  • Active infection, sepsis, osteomyelitis or history of septic arthritis involving the hindfoot/midfoot
  • Condition does not qualify for a total talus replacement
  • Unable to consent or participate in the study secondary to mental status
  • Patients who are pregnant or imprisoned
  • Planned relocation or unable to return for required follow-up visits

Helyszínek itt: Egyesült Államok

  • University of MissouriColumbia, Egyesült ÁllamokContact: Ennio R EspositoRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

Avascular necrosis of the talus is a difficult problem to manage, especially in the young and healthy. The only option, historically, has been a talectomy and hindfoot fusion. While this is a viable option, it is not without its morbidity. Arthritis of surrounding joints is common, occurring anywhere from 1-10 years after the procedure. This is especially true in younger patients, where loss of motion can be life altering both physically and mentally. The search for alternatives has been limited. Recently, 3D printing has become more ubiquitous and affordable and newer medical alternatives have arisen thanks to this technology. The 3D custom talus is relatively new in the orthopaedic community, but has been used at several centers with good success. It has been shown to re-establish the normal alignment of the foot, preserve motion (with some achieving almost physiologic motion), and allow for almost normal ambulation. However, the data is still limited and further study is necessary. Our facility was recently approved to perform this procedure. Our hypothesis is that custom 3D printed talar body replacements, either used alone or with total ankle replacements, will maintain physiologic motion, have no difference in complications when compared to hindfoot fusions with allograft, lead to good outcome scores and patient satisfaction scores. Patients diagnosed with avascular necrosis of the talus who have already decided to undergo a procedure involving a 3D custom talus as part of their standard care (talar replacement, total ankle/total talus, etc) will be enrolled in the study. Patients will follow standard post-operative protocols and return to clinic at designated time periods (2 weeks, 6 weeks, 3 months, 6 months, 1 year). X-ray evaluation, Range of motion, return to ambulation, walking speed and patient reported outcomes will be evaluated at each visit. Data will then be compared with baseline measurements and use to determine the progression of patients over time after the procedure

A vizsgálat csoportja

  • 3D talar group

    Patients that will undergo a 3D custom talar augment

    Kezelés: 3D talar augmentation

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
A regiszteradat frissítve
2026. április 28.