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A Clinical Translational Study on Repairing Articular Cartilage Injury With Autologous Adipose Gel

7. juli 2021 opdateret af: Peking University Third Hospital
66 articular cartilage injury diseases patients were divided into two groups as 1:1. The test group will be treated with arthroscopic micro-fracture with autologous adipose gel, and the control group will be treated with arthroscopic micro-fracture. Postoperative MRI evaluation, Lysholm score, IKDC score, Tegner score, and VAS score will be used as the treatment validity evaluation index, at the same time testing blood routine, blood biochemistry, urine routine, CRP, electrocardiogram and other laboratory tests and recording the occurrence of adverse events.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In this study, 66 patients who were clinically diagnosed as articular cartilage injury diseases were divided into test group and control group according to the ratio of 1:1. The test group will be treated with arthroscopic micro-fracture with autologous adipose gel, and the control group will be treated with arthroscopic micro-fracture. Postoperative MRI evaluation, Lysholm score, IKDC score, Tegner score, and VAS score will be used as the treatment validity evaluation index, at the same time testing blood routine, blood biochemistry, urine routine, CRP, electrocardiogram and other laboratory tests and recording the occurrence of adverse events.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

66

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100191
        • Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. ≥18 years old and ≤50 years old, male or female patients
  2. Patients with knee articular cartilage defect area ≥2cm2 and ≤8cm2, who can undergo microfracture surgery, no surgical contraindications
  3. Patients voluntarily participate in clinical trials, sign an informed consent form, and be able to cooperate with clinical follow-up

Exclusion Criteria:

  1. Participants in clinical trials of other drugs or medical devices in the past 6 months
  2. Unable to accept autologous fat glue due to religion, ethnicity, etc.
  3. Injury area <2 cm2 or >8cm2 or lack of normal cartilage tissue surrounding the injury
  4. Those with compound multiple ligament injuries
  5. Those with systemic immune diseases or systemic or local infections
  6. Those with joint fibrosis, joint ankylosis, and obvious limitation of movement
  7. People with moderate to severe osteoarthritis
  8. Those who have contraindications to MRI examination
  9. Patients with hemophilia
  10. People whose general condition cannot tolerate surgery
  11. Women who are pregnant or planning to become pregnant and women who are breastfeeding
  12. Mental abnormalities and no behavioral autonomy
  13. Other circumstances in which the doctor judges that he cannot participate in the trial

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: arthroscopic microfracture with autologous adipose gel
The experimental group will be treated with arthroscopic microfracture with autologous adipose gel.
Procedure: arthroscopic micro-fracture with autologous adipose gel
Fully cut the adipose tissue taken out under the arthroscopy, transfer the cut adipose tissue to a syringe connected with a double pass, push back and forth through the syringe to physically emulsify the adipose, and centrifuge to obtain the autologous adipose gel, and inject it into the lesion
Aktiv komparator: arthroscopic microfracture
The control group will be treated with arthroscopic microfracture.
Procedure: arthroscopic micro-fracture
Surgeons routinely perform international standard micro-fracture surgery to repair cartilage damage

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assessing a change of MRI Evaluation of Articular Cartilage Injury after Repair
Tidsramme: Knee MRI examinations were performed on patients baseline, 5 days, 90 days, 180 days, and 365 days after operation.
Assessing a change of postoperative MRI evaluation with autologous fat glue combined with micro-fracture treatment or micro-fracture treatment articular cartilage injury
Knee MRI examinations were performed on patients baseline, 5 days, 90 days, 180 days, and 365 days after operation.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lysholm score
Tidsramme: Lysholm score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
Assessing a change of Lysholm score between two groups of patients
Lysholm score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
IKDC score
Tidsramme: IKDC score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
Assessing a change of IKDC score between two groups of patients
IKDC score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
Tegner score
Tidsramme: Tegner score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
Assessing a change of Tegner score between two groups of patients
Tegner score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
VAS score
Tidsramme: VAS score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
Assessing a change of VAS score between two groups of patients
VAS score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Peking University Third Hospital

Efterforskere

  • Ledende efterforsker: Yingfang Ao, Prof., Peking University Third Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. december 2021

Primær færdiggørelse (Forventet)

1. december 2022

Studieafslutning (Forventet)

1. december 2023

Datoer for studieregistrering

Først indsendt

25. juni 2021

Først indsendt, der opfyldte QC-kriterier

7. juli 2021

Først opslået (Faktiske)

8. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2021

Sidst verificeret

1. juli 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • M2020311

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