Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
56 participants
INTERVENTIONAL
2024-03-02
2036-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Restoration Anatomic Acetabular Shell
Restoration Anatomic Acetabular Shell
Multi-hole acetabular shell intended for cementless fixation into a prepared acetabulum and is a modular component design that is assembled intra-operatively.
Interventions
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Restoration Anatomic Acetabular Shell
Multi-hole acetabular shell intended for cementless fixation into a prepared acetabulum and is a modular component design that is assembled intra-operatively.
Eligibility Criteria
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Inclusion Criteria
* Subject has signed an IRB-approved, study specific Informed Consent Form (ICF).
* Subject is skeletally mature.
* Subject is a male or non-pregnant female.
* Subject is willing and able to comply with postoperative scheduled clinical evaluations.
Exclusion Criteria
* Subject has a Body Mass Index (BMI) \> 45.
* Subject has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
* Subject has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
* Subject has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis.
* Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
* Subject is immunologically suppressed or receiving steroids in an excess of normal physiological requirements (e.g. \> 30 days).
* Subject has a known sensitivity to device materials.
* Subject is a prisoner.
ALL
No
Sponsors
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Stryker Orthopaedics
INDUSTRY
Responsible Party
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Locations
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Regents of the University of Colorado
Denver, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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105
Identifier Type: -
Identifier Source: org_study_id
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