Osteoarthritis of Hip
Conditions
Brief summary
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
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
Interventions
DEVICEBioguard Group
Patients randomised to receive the study investigative device will receive a Bioguard implant
DEVICEControl Group
Patients randomised to receive the control device will receive a Exceed Taperlock implant
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in normalised peri-implant BMD as measured by DXA | 6 months post operative |
Countries
United Kingdom
Outcome results
None listed