- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03060655
Study of PLGA-Mg Material in Clinical Orthopedics
Randomized, Double Blind Trial of Study of PLGA-Mg Material in Clinical Orthopedics
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The deposition of calcium could be facilitated by the increase of magnesium, which played an important role in fracture union. However, its degradation may be completed before the fracture line was disappeared. In addition, the hydrogen may be released during degradation. Thus, its clinical popularization was limited.
As a new polymer material, poly lactic-co-glycolic acid (PLGA) has been widely used clinically. The hydrolytic production of PLGA was acidic, which could neutralize the alkalinity of production degraded from magnesium. In addition, it was a long time before the total accomplishment of degradation of PLGA, which may postpone the degradation of magnesium.
The different proportion samples of PLGA-Mg were made in this study. Their physical and chemical properties were analyzed to estimate its safety of implantation. Then, they would be placed in the femoral condyle of the New Zealand rabbits. The osteogenesis and complication of samples are examined to select an appropriate proportion of PLGA-Mg is obtained. Then, the PLGA-Mg material will be used to fix the fracture of human as a fixation. The review of the patients will be conducted to assess its clinical role.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Yingze Zhang, M.D
- Telefonnummer: +8613313012888
- E-mail: yzzhangdr@126.com
Studiesteder
-
-
Hebei
-
Shijiazhuang, Hebei, Kina, 050051
- Rekruttering
- Hebei Medical University Third Hospital
-
Kontakt:
- Yingze Zhang, M.D
- Telefonnummer: +8613313012888
- E-mail: yzzhangdr@126.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 18-65 years old
- Closed fracture
- Sign the agreement of the experiment
Exclusion Criteria:
- Pathologic fracture
- Open fracture
- Refused to participate
- Follow-up insufficient 12 months
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: PLGA-Mg material
The fixation of fragments of study group was accomplished with PLGA-Mg material.
|
The PLGA-Mg material was used to accomplish the fixation of fragments.
Then, the clinical outcome was assessed.
|
Placebo komparator: titanium alloy
The fixation of fragments of control group was accomplished with titanium alloy material.
|
Traditional fixation was titanium alloy.
the clinical outcome was assessed.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
fracture union time
Tidsramme: 4 months
|
4 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
complication
Tidsramme: 1 months
|
nonunion, toxicity
|
1 months
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ZYZ2017
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med PLGA-Mg material
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Kirsehir Ahi Evran UniversityAfsluttet
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Manhattan Beach OrthodonticsAfsluttetSøvnapnø | OSAForenede Stater
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Virender S Sangwan, MBBS, MSUniversity of Sheffield; Wellcome TrustAfsluttetLimbal stamcelle mangelIndien
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University of Campinas, BrazilAfsluttetPeriodontal sygdomBrasilien
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Jaakko SinikumpuOulu University Hospital; Bioretec Ltd.Afsluttet
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British University In EgyptAfsluttetBakterielle infektioner OralEgypten
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Péterfy Sándor HospitalRekruttering
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University of Campinas, BrazilPontificia Universidade Catolica de Sao PauloAfsluttet