Investigation to Determine Safety of Taperloc Stems With BioGuard Coating When Used in Cementless Total Hip Arthroplasty

Study Overview
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Brief Summary
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Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in cementless total hip arthroplasty

Detailed Description
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Bioguard Safety Study: Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in cementless total hip arthroplasty

Official Title
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Prospective Clinical Investigation to Determine the Safety of Taperloc Stems With BioGuard Coating and Exceed ABT Taperfit Acetabular Cups With BioGuard Coating When Used in Cementless Total Hip Arthroplasty

Conditions
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Osteoarthritis of Hip

Intervention / Treatment
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* Device: Bioguard Group
* Device: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible for cementless primary total hip arthroplasty according to the Surgical Technique brochure (Appendix 10): The Taperloc Porous Primary Hip and Exceed ABT Taperfit Prostheses are marketed for non-cemented use in skeletally mature patients undergoing primary hip replacement surgery of non inflammatory degenerative joint disease. Under 80 and over 40 years of age A pre-operative level of pain and function the same as for conventional joint replacement. A likelihood of obtaining relief of pain and improved function Full skeletal maturity Ability to follow instructions Good general health for age Willing to return for follow-up evaluations Exclusion Criteria: Patients aged over 80 and under 40 years Known allergy to any antibiotics Active infection Revision arthroplasty Marked bone loss which could preclude or compromise adequate fixation of the device Uncooperative subjects Parkinson's Disease Vascular insufficiency of the affected limb, which could compromise bony ingrowth/implant fixation, i.e., diabetes. Severe instability or deformity of the ligaments and/or surrounding soft tissue which may preclude stability of the device Pregnancy BMI > 40 Use of immunosuppressive drugs Women of child bearing potential

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bioguard Group<br>Randomised study to either Bioguard or control stock | Device: Bioguard Group<br>* Patients randomised to receive the study investigative device will receive a Bioguard implant<br>* Other names: Bioguard device;|
| Active Comparator: Control Group<br>Randomised study to either Bioguard or control stock | Device: Control Group<br>* Patients randomised to receive the control device will receive a Exceed Taperlock implant<br>* Other names: Exceed Taperlock;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in normalised peri-implant BMD as measured by DXA |  | 6 months post operative |