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Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects (Mfxbracing)

31. mai 2019 oppdatert av: Jason L. Dragoo, Stanford University

Effects of Unloader Bracing in Clinical Outcome and Articular Cartilage Physiology Following Microfracture of Isolated Chondral Defects

The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.

The surgery performed will be the same for all patients

The length of follow up and schedule of post-operative MRI will be the same for all patients.

The only difference in groups will be presence of absence of brace wear.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Radiographic outcome will be assessed via MRI scans post-operatively. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.

The surgery performed will be the same for all patients

The length of follow up and schedule of post-operative MRI will be the same for all patients.

The only difference in groups will be presence of absence of brace wear.

Studietype

Intervensjonell

Registrering (Faktiske)

24

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Redwood City, California, Forente stater, 94063
        • Stanford University Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

15 år til 40 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • isolated chondral defect of medial or lateral femoral condyle 2cm squared or less
  • age 15-40
  • neutral knee alignment

Exclusion Criteria:

  • prior cartilage procedures performed in the same knee
  • other significant knee pathology including meniscus tears, ligament tears or inflammatory arthritis

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Unloader Bracing
This group will be randomly selected and assigned to wear an unloader brace post-operatively during the study period.
Enhet: Unloader Bracing
The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period.
Andre navn:
  • Ossur Unloader Brace
Aktiv komparator: Non-Bracing Arm
This group will be randomly selected and assigned to wear no brace post-operatively.
Enhet: Non-Bracing
Microfracture performed with no post-operative unloader bracing

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome)
Tidsramme: 2 years
KOOS is a validated outcome score that evaluates knee symptoms, knee pain, knee use in activities of daily living, function in sport and recreation and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
2 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Tegner Score (Clinical Outcome)
Tidsramme: 2 years
The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score >6 can only be achieved if the person participates in recreational or competitive sport.
2 years
Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome)
Tidsramme: 2 years
SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life. A higher value indicates a better quality of life of the patient. The scores range from 0 to 100.
2 years
Change From Baseline in Lysholm Score (Clinical Outcome)
Tidsramme: 2 years
The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.
2 years
Change From Baseline in T2 Relaxation Time (Radiographic Outcome)
Tidsramme: 2 years
T2 imaging assesses hydration of cartilage as well as collagen fiber orientation and loss of type II collagen.
2 years
Change From Baseline in Cartilage Volume (Radiographic Outcome)
Tidsramme: 2 years
2 years
Change From Baseline in Cartilage Thickness (Radiographic Outcome)
Tidsramme: 2 years
2 years

Samarbeidspartnere og etterforskere

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Sponsor

Stanford University

Etterforskere

  • Hovedetterforsker: Jason Dragoo, MD, Stanford University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2013

Primær fullføring (Faktiske)

1. juni 2018

Studiet fullført (Faktiske)

1. juni 2018

Datoer for studieregistrering

Først innsendt

2. desember 2013

Først innsendt som oppfylte QC-kriteriene

13. desember 2013

Først lagt ut (Anslag)

19. desember 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. juni 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. mai 2019

Sist bekreftet

1. mai 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • oss-mfx-2013

Plan for individuelle deltakerdata (IPD)

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NEI

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