Investigation to Determine Safety of Taperloc Stems With BioGuard Coating When Used in Cementless Total Hip Arthroplasty
Not Applicable
Active, not recruiting
- Conditions
- Osteoarthritis of Hip
- Registration Number
- NCT02263209
- Lead Sponsor
- Zimmer Biomet
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in normalised peri-implant BMD as measured by DXA 6 months post operative
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does BioGuard coating utilize to enhance osseointegration in cementless hip implants?
How does the Taperloc stem with BioGuard coating compare to standard cementless hip stems in terms of clinical outcomes and implant stability?
Are there specific biomarkers that correlate with successful osseointegration of BioGuard-coated hip implants in osteoarthritis patients?
What are the known adverse events associated with BioGuard-coated Taperloc stems and Exceed ABT Taperfit cups in hip arthroplasty?
How do BioGuard-coated implants from Zimmer Biomet compare to competitor devices like Stryker's Triton stem in cementless hip arthroplasty?
Trial Locations
- Locations (1)
RJAH
🇬🇧Oswestry, United Kingdom
RJAH🇬🇧Oswestry, United Kingdom