- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00855023
Knee Alignment Contributions to Anterior Cruciate Ligament (ACL) Injury
Tibiofemoral Alignment: Contributing Factors to Noncontact Anterior Cruciate Ligament Injury
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Despite intense study of anterior cruciate ligament injury during the past three decades, the mechanisms of this injury have not been clearly defined. A recent study by the Principle Investigator identified differences in leg alignment when a single leg landing during a sports activity resulted in a torn ACL and when it did not (provocative versus control alignment, respectively).
The purpose of the study is to quantify the tibiofemoral alignment in the lateral compartment of the knee in the provocative landing position and the control landing position. in order to elucidate possible mechanisms of ACL injury Material and Methods: 25 normal controls will be recruited from the greater Washington DC population. Magnetic resonance images in the sagittal plane will be acquired for a single leg of each subject. These images will cover the lateral compartment of the knee and will be acquired with the leg in three positions, one that emulates the injury position, one that exagerrates the injury position, and one that emulates the control landing position. Statistical analysis of the measurements between the provocative, exagerrated provocative, and control positions will then be performed.
These insights could then be applied to improving training focused on reducing the incidences of ACL rupture; improving bracing designs to help athletes most at risk of ACL rupture or those recovering from ACL injury/surgery; and improving ACL replacement surgeries.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Maryland
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Rockville, Maryland, Forenede Stater, 20850
- Open MRI of Washington
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Healthy controls
- Ages 18-45 years old
Exclusion Criteria:
- Previous knee injury or surgery
- Metal implants in body
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Asymptomatic Volunteers
healthy volunteer athletes and excluded those who had any of the following criteria: 1) counter-indications to magnetic resonance imaging (e.g., pregnancy or postsurgical hardware [plates, screws, aneurysm clip, implanted cardiac pacemaker, etc.]); (2) relevant medical problems (e.g., connective tissue problems, paralyzed hemidiaphragm, morbid obesity, claustrophobia, etc.); (3) clinical signs of an impairment or abnormality in the knee (e.g., abnormal range of motion, muscle weakness, or malalignment); (4) injury to the knee that required medical attention; (5) previous surgery on the knee; or (6) current pain in the knee.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Measurement of anatomy of knee
Tidsramme: 1 hour
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1 hour
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Barry P Boden, MD, The Orthopedic Center
Publikationer og nyttige links
Generelle publikationer
- Boden BP, Torg JS, Knowles SB, Hewett TE. Video analysis of anterior cruciate ligament injury: abnormalities in hip and ankle kinematics. Am J Sports Med. 2009 Feb;37(2):252-9. doi: 10.1177/0363546508328107.
- Boden BP, Breit I, Sheehan FT. Tibiofemoral alignment: contributing factors to noncontact anterior cruciate ligament injury. J Bone Joint Surg Am. 2009 Oct;91(10):2381-9. doi: 10.2106/JBJS.H.01721.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
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
- 07-08-229-147
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Kliniske forsøg med Knæskader
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Smith & Nephew, Inc.Nor Consult, LLCAfsluttetJourney II XR Total Knee SystemForenede Stater
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Smith & Nephew, Inc.AfsluttetSikkerhed og ydeevne af Journey II BCS Total Knee System Patient rapporterede resultatmål (JIIPROMS)Journey II BCS Total Knee SystemForenede Stater, Belgien, New Zealand
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Smith & Nephew, Inc.Nor ConsultAfsluttetJourney II CR Total Knee SystemForenede Stater
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Maxx Orthopedics IncRekrutteringKnogletab | Periprotetiske frakturer | Infektion | Aseptisk Løsning | MCL - Medial Collateral Ligament Rupture of the KneeForenede Stater