Study of PLGA-Mg Material in Clinical Orthopedics
Randomized, Double Blind Trial of Study of PLGA-Mg Material in Clinical Orthopedics
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Hebei
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Shijiazhuang, Hebei, Kina, 050051
- Rekruttering
- Hebei Medical University Third Hospital
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Ta kontakt med:
- Yingze Zhang, M.D
- Telefonnummer: +8613313012888
- E-post: yzzhangdr@126.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: PLGA-Mg material
The fixation of fragments of study group was accomplished with PLGA-Mg material.
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The PLGA-Mg material was used to accomplish the fixation of fragments.
Then, the clinical outcome was assessed.
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Placebo komparator: titanium alloy
The fixation of fragments of control group was accomplished with titanium alloy material.
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Traditional fixation was titanium alloy.
the clinical outcome was assessed.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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fracture union time
Tidsramme: 4 months
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4 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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complication
Tidsramme: 1 months
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nonunion, toxicity
|
1 months
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ZYZ2017
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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