- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01672320
Outcomes of Robotic Total Hip Arthroplasty
Outcomes of Robotic Total Hip Arthroplasty: A Prospective Study
The objectives of this study are to evaluate the clinical value of robotic-assisted total hip arthroplasty with respect to acetabular cup implantation, and to document the long-term clinical outcome of patients with Total Hip Arthroplasty (THA). IRB approval will be obtained at every study site to evaluate the basic clinical outcomes and post-operative component placement accuracy of each MAKO® THA patient.
The hypothesis is that robotic preparation of the acetabulum will significantly reduce the variability and inaccuracy in the component alignment parameters that lead to post-operative complications, including implant failure.
Studieöversikt
Status
Betingelser
Studietyp
Kontakter och platser
Studieorter
-
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General 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
Beskrivning
Inclusion Criteria:
- Male or female
- 20 to 75 years of age
- Subjects requiring primary total hip replacement
- Contralateral hip should be relatively free from arthritis for comparison purposes, specifically with less than a grade of 2 on the Kellgren-Lawrence Scale.
- Subjects diagnosed with osteoarthritis or traumatic arthritis
- Subjects with avascular necrosis
- Subjects who demonstrate the ability to return for follow-up for the next 10 years
Exclusion Criteria:
- Subjects with difficulty understanding protocol for any reason
- Subjects with a limited life span
- Subjects with inflammatory hip disease, previous joint infection, or those requiring hip revision surgery
- Female subjects who are pregnant, or who plan to get pregnant while enrolled in the study
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
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Phase II
An evaluation of long-term outcomes, patient reported outcomes, and radiographic analysis will be conducted prospectively on 500 patients
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Phase I
An analysis of post-operative component positioning will be evaluated for 500 patients, retrospectively.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Survivorship of Components
Tidsram: 10 Years
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Defined as implant remaining in subject.
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10 Years
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Adverse Events
Tidsram: 10 Years
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Protocol deviations, complications, "lost to follow-up"
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10 Years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Retrieval Analysis of implants from revision surgery
Tidsram: Up to 10 Years
|
When possible, analysis of the THR components that are removed at revision surgery will be anlaysed for signs of component impingment or signs of damage related to component position.
These observations will be correlated to the clinical reason for revision.
|
Up to 10 Years
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Assessment/questionaire HOOS
Tidsram: Pre-op, 1, 3, 5, 7, 10 years after surgery
|
Hip Disability and Osteoarthritis Outcome
|
Pre-op, 1, 3, 5, 7, 10 years after surgery
|
Assessment/Questionaire UCLA Activty Score
Tidsram: Pre-op, 1, 3, 5, 7, 10 years after surgery
|
Assesses level of activity
|
Pre-op, 1, 3, 5, 7, 10 years after surgery
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Assessment/Questionaire EQ-5D
Tidsram: Pre-op, 1, 3, 5, 7, 10 years after surgery
|
General health and cost effective analysis
|
Pre-op, 1, 3, 5, 7, 10 years after surgery
|
Assessment/questionaire
Tidsram: Pre-op, 1, 3, 5, 7, 10 years after surgery
|
Hip desease specific questionaire
|
Pre-op, 1, 3, 5, 7, 10 years after surgery
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Assessment/Questionaire Case Mix Indicator
Tidsram: Pre-op, 1, 3, 5, 7, 10 years after surgery
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Identifies comorbidities
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Pre-op, 1, 3, 5, 7, 10 years after surgery
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2012P000809
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