- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01833481
THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches (THA)
In Vivo Determination of THA Kinematics and Sound for Subject Implanted Using Various Surgical Approaches
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Maryland
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Towson, Maryland, Förenta staterna, 21201
- University of Maryland St. Joseph Medical Center
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Washington
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Renton, Washington, Förenta staterna, 90855
- Valley Orthopedic Associates ASC
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Ontario
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London, Ontario, Kanada, N6A 5A5
- University Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Patients implanted with a direct-anterior surgical approach will be provided by Dr. William Barrett of Valley Orthopedic Associates in Renton, WA.
Patients implanted with an anterior-lateral surgical approach will be provided by Dr. of Steven J. MacDonald of the London Health Sciences Center, London, Ontario.
Patients implanted with a posterior-lateral approach will be provided by Dr. David F. Dalury of Towson Orthopaedic Associates, Inc. in Towson, MD.
Beskrivning
Inclusion Criteria:
- Post-operative clinical evaluation judged successful using Harris Hip Scoring (HHS) system (HHS>90)
- Body weight less than 270 lbs
- No evidence of post-operative hip subluxation or dislocation
- Do not walk with detectable limp
- Be able to actively abduct their operated hip against gravity without difficulty
- Must be willing to sign Informed Consent and Health Insurance Portability and Accountability (HIPAA) forms
Exclusion Criteria:
- Pregnant, lactating or females not using reliable form of birth control
- Patients that do not meet study requirements
- Patients unwilling to sign Informed Consent or HIPAA forms
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
THA using direct-anterior surgical approach
Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.
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While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
Andra namn:
|
THA using anterior-lateral approach
Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
|
While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
Andra namn:
|
THA using posterior-lateral approach
Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
|
While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Kinematics - Swing Phase Separation
Tidsram: 6 months post-operatively
|
Determine amount of in vivo swing phase hip separation present within implanted hip during weight-bearing level walking while under fluoroscopic surveillance.
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6 months post-operatively
|
Kinematics - Stance Phase Separation
Tidsram: 6 months post-operative
|
Determine amount of stance phase hip separation present in vivo of implanted hip during level walking activity under fluoroscopic surveillance.
|
6 months post-operative
|
Kinematics - Overall Separation
Tidsram: 6 months post-operative
|
Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance
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6 months post-operative
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Adrija Sharma, Ph D, The University of Tennessee
- Huvudutredare: Richard D Komistek, Ph D, The University of Tennessee
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 12009
- R01 1373 452 (Annan identifierare: University of Tennessee)
- 13-0372 (Annan identifierare: University of Tennessee)
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