Pilot Study Evaluating the Safety and Efficacy of a New Hard-on-Hard Total Hip Replacement System
NCT ID: NCT02154516
Last Updated: 2024-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2011-11-04
2022-10-18
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Total Hip Replacement Device
Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* OXINIUM heads on polyethylene liners or
* Ceramic heads on ceramic liners (all uncemented components)
ODH Hip System
Investigational Hard-on-Hard Total Hip Replacement Device
Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
* R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
* Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
ODH Hip System
Interventions
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ODH Hip System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Skeletally mature
* Requires primary, unilateral total hip arthroplasty due to degenerative join disease
* Preoperative Harris Hip Score of less than or equal to 70
* Meets an acceptable preoperative medical clearance and is free or treated for conditions that would pose excessive operative risk
* Given consent to participate in the study
* Able to understand the purpose of the study, his/her role, and is available for follow-up
10 year extension:
* Subject has completed the 2 year primary study
* Subject has signed an Independent Ethics Committee (IEC) approved Informed Consent Form agreeing to participate in the extension study after the nature, scope and possible consequences of the study have been explained in an understandable form
* Subject is able to fully understand the purpose of the study, his/her role as a participant in the study, and plans to be available through ten years post-operative follow-up
Exclusion Criteria
* Requires bilateral THA
* Requires revision of a prior hip replacement
* Active infection or sepsis
* History of local hip infection
* Known metastatic or neoplastic disease
* Conditions that may interfere with THA survival or outcomes
* Need for structural bone grafts to support the implant
* Contralateral lower extremity condition
* Has other joint replacements or plans for other joint replacements within 2 years
* Systemic steroid therapy within 3 months prior to surgery
* Life expectancy less than 2 years
* Intra-articular therapy within 6 months of enrollment
* Female of child-bearing age not using contraception
* Inadequate bone stock to support the device
* Moderate to severe renal insufficiency
* Emotional or neurological condition that would pre-empt ability or willingness to participate in the study
* BMI \>40
* Above the knee amputation of the contralateral or ipsilateral leg
* Known allergies to the components of the devices
* Entered into another investigational study
* Is a prisoner
10 year extension:
• In the opinion of the surgeon, the subject's health, safety or well-being may be compromised or harmed by continuation in the extension phase or participation may not be in the subject's best interests.
21 Years
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew Baker
Role: PRINCIPAL_INVESTIGATOR
Entabeni Hospital
Johannes de Beer
Role: PRINCIPAL_INVESTIGATOR
Zuid Afrikaans Hospital
Locations
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Entabeni Hospital
Durban, , South Africa
Zuid Afrikaans Hospital
Pretoria, , South Africa
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2011-ODHH166
Identifier Type: -
Identifier Source: org_study_id