- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02154516
Pilot Study Evaluating the Safety and Efficacy of a New Hard-on-Hard Total Hip Replacement System
A Consecutive Series Pilot Study Evaluating the Safety and Effectiveness of a New Hard-on-Hard Total Hip Replacement System in Patients With Non-inflammatory Arthritis With a Standard THA Metal Ion Control Group
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Durban, South Africa, 4001
- Entabeni Hospital
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Pretoria, South Africa, 0002
- Zuid Afrikaans Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least 21 years old
- 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:
- Diagnosis with high risk of Total Hip Arthroplasty (THA) failure
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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:
|
Other Names:
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Experimental: 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:
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Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Revision Rate
Time Frame: Up to 10 Years
|
Reoperations that led to removal or replacement of any of the acetabular or femoral components.
|
Up to 10 Years
|
Adverse Events
Time Frame: Up to 10 Years
|
Up to 10 Years
|
|
Metal Ion Concentration in Whole Blood
Time Frame: Up to 10 years
|
Up to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Harris Hip score
Time Frame: Up to 10 years
|
Up to 10 years
|
|
Hip Disability and Osteoarthritis Outcome Scores (HOOS)
Time Frame: Up to 10 years
|
Up to 10 years
|
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Radiographic measures
Time Frame: Up to 10 years
|
Assessment of bone loss, radiolucencies, subsidence, and heterotopic ossification
|
Up to 10 years
|
Health economic outcomes-Surgical blood loss
Time Frame: Intra-operative
|
Measured in ml blood
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Intra-operative
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Health economic outcomes -Length of hospital stay
Time Frame: Hospital admission to discharge
|
Measure of days spent in hospital
|
Hospital admission to discharge
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Health economic outcomes-Operative time
Time Frame: Intra-operative
|
Operative time - first incision into skin to time when last suture is applied
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Intra-operative
|
Health economic outcomes - Re-hospitalisations
Time Frame: Up to 10 years
|
Re-hospitalisations-number of re-admissions to hospital
|
Up to 10 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-ODHH166
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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