Clinical Effect of Allogeneic Meniscus Transplantation
4. juli 2021 opdateret af: Peking University Third Hospital
In this study, patients who underwent allogeneic meniscus transplantation and meniscus resection were followed up for more than 10years to evaluate the long-term efficacy and explore the cartilage protective role of meniscus transplantation.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
To investigate the long-term clinical effect of allogeneic meniscus transplantation, IKDC score, Lysholom score, Tegner score, VAS score, etc. were used to compare the clinical effects of allogeneic meniscus transplantation, and the progress of knee joint degeneration and cartilage injury was evaluated through X-ray and MRI.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
38
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100191
- Institute of Sports Medicine, Peking University Third Hospital
-
-
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
16 år til 46 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
The age is less than 50 years; the force line is basically normal (≤ ± 3°); the joint is stable or the joint stability is corrected at the same time during the operation; the joint degeneration or large area cartilage damage. In the transplantation group, 10 patients experienced pain or swelling in the joint space of the affected side for an average of 35 months after meniscus resection, and then received meniscus transplantation. The other 8 patients underwent meniscus transplantation at the same time as meniscus resection. Patients in the resection group received meniscus transplantation at the same time. Symptoms, signs, and magnetic resonance imaging (MRI) were diagnosed as a meniscus tear and the judgment during the operation could not be preserved, so a total meniscus was performed.
Exclusion Criteria:
Severe knee synovial disease; severe joint degeneration or extensive cartilage damage; improper force lines; severely unstable joints that cannot be corrected; both meniscuses are removed; the other knee joint has a history of severe trauma or surgery.
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: Meniscus Allograft Transplantation
The patient underwent Meniscus Allograft Transplantation
|
patients received surgery of Meniscus Allograft Transplantation
|
|
Aktiv komparator: Meniscectomy
The patient underwent Meniscectomy
|
patients received surgery of Meniscectomy
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Magnetisk resonansbilleddannelse (MRI)
Tidsramme: Før operationen
|
Alle MR-scanninger blev foretaget med en 3.0-T MR-scanner (Magnetom Trio med TIM-system, Siemens Healthcare).
Fem rutinemæssige MR-sekvenser med en snittykkelse på 4 mm blev opnået hos alle patienter.
Præoperative og postoperative evalueringer af ledbrusken i det transplanterede rum blev udført med Yulish-score41 (grad 0 = normal; grad 1 = normal kontur 6 unormalt signal; grad 2 = overfladisk flossning, erosion eller ulceration på <50 %; grad 3 = delvis tykkelsesdefekt på >50 % men <100 %; grad 4 = brusktab i fuld tykkelse).
Signalet fra menisk-allotransplantatet i koronalplanet af den T2-vægtede hurtige spin-ekkosekvens blev graderet på en skala fra 0 til 3.
|
Før operationen
|
|
Røntgenbilleder
Tidsramme: Før operationen
|
Alle patienter fik også 45° fleksion, vægtbærende AP-røntgenbilleder af både de ipsilaterale og kontralaterale sider ved den endelige opfølgning.
Røntgenbilledet af den samlede længde af underekstremiteterne blev brugt til at evaluere tilpasningen.
I AP almindelige røntgenbilleder blev den korteste afstand mellem lårbenskondylen og tibialplateauet på den transplanterede side målt og betegnet som ledrummets højde.
Forskellen mellem de ipsilaterale og kontralaterale sider blev beregnet for at identificere ledrumsindsnævring.
Derudover blev Kellgren-Lawrence (K-L) gradering brugt til at vurdere knæets slidgigtstatus.
|
Før operationen
|
|
Radiographs
Tidsramme: 10 years after the operation
|
All patients also obtained 45° flexion weightbearing AP radiographs of both the ipsilateral and contralateral sides at final follow-up.
The radiograph of the total length of the lower limbs was used to evaluate alignment.
In the AP plain radiographs, the shortest distance between the femoral condyle and tibial plateau of the transplanted side was measured and designated as the joint space height.
The difference between the ipsilateral and contralateral sides was calculated to identify joint space narrowing.
In addition, Kellgren-Lawrence (K-L) grading was used to assess the osteoarthritic status of the knee.
|
10 years after the operation
|
|
Magnetic resonance imaging (MRI)
Tidsramme: 10 years after the operation
|
All MRI scans were obtained with a 3.0-T MRI scanner (Magnetom Trio with TIM system, Siemens Healthcare).
Five routine MRI sequences with a section thickness of 4 mm were obtained in all patients.
Preoperative and postoperative evaluations of the articular cartilage of the transplanted compartment were performed with the Yulish score41 (grade 0 = normal; grade 1 = normal contour 6 abnormal signal; grade 2 = superficial fraying, erosion, or ulceration of <50%; grade 3 = partial-thickness defect of >50% but <100%; grade 4 = full-thickness cartilage loss).
The signal of the meniscus allograft in the coronal plane of the T2-weighted fast spin echo sequence was graded on a scale of 0 to 3.
|
10 years after the operation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
visual analog scale (VAS) scores
Tidsramme: Before and 10 to 15 years after the operation
|
visual analog scale (VAS) scores was applied to evaluate knee pain.
0 points means no pain, 10 points means severe pain.
|
Before and 10 to 15 years after the operation
|
|
International Knee Documentation Committee (IKDC) score
Tidsramme: Before and 10 to 15 years after the operation
|
At present, it is recognized internationally that IKDC has relatively high reliability, effectiveness and sensitivity for the assessment of At present, it is recognized internationally that IKDC has relatively high reliability, effectiveness and sensitivity for the assessment of the subjective and objective symptoms of the knee joint system.
|
Before and 10 to 15 years after the operation
|
|
Tegner score
Tidsramme: Before and 10 to 15 years after the operation
|
This score is widely used by exercise assessors for patients with knee joint disease.
This scoring method divides the patient's exercise level into 0-10 points, 0 as disability, and 10 as being able to participate in national competitive sports.
|
Before and 10 to 15 years after the operation
|
|
Lysholm score
Tidsramme: Before and 10 to 15 years after the operation
|
This score is often used together with the Tegner score.
The scores of this scoring system are generally high and focus more on the assessment of daily activities rather than sports.
|
Before and 10 to 15 years after the operation
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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 (Faktiske)
1. februar 2005
Primær færdiggørelse (Faktiske)
1. april 2021
Studieafslutning (Faktiske)
1. april 2021
Datoer for studieregistrering
Først indsendt
27. juni 2021
Først indsendt, der opfyldte QC-kriterier
4. juli 2021
Først opslået (Faktiske)
13. juli 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. juli 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juli 2021
Sidst verificeret
1. juni 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 200506M
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Meniscus Allograft Transplantation
-
Brigham and Women's HospitalUnited States Department of DefenseAfsluttetAlvorlig ansigtsdeformitetForenede Stater
-
University of StellenboschAfsluttet
-
Mayo ClinicTilmelding efter invitationStrubehoved | Larynx sygdom | Laryngektomi | Larynx stenose | Larynx frakturForenede Stater
-
Paul Fortin, MDMusculoskeletal Transplant FoundationAfsluttet
-
University of Southern CaliforniaNational Cancer Institute (NCI)RekrutteringImmunsuppression | Neurogen blære | Blære dysfunktionForenede Stater
-
University of Missouri-ColumbiaTilmelding efter invitationSymptomatisk osteochondral defekt(er) | Brusk, menisk, ankel, knæ, skulder, hofteForenede Stater
-
University of Colorado, DenverIkke rekrutterer endnuHåndled slidgigt
-
Conmed Linvatec BeneluxUkendt
-
University of Alabama at BirminghamBioDlogicsAktiv, ikke rekrutterende
-
University of LouisvilleAfsluttetAlveolær procesdefektForenede Stater