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
• Interventions: Device: Control Group; Device: Bioguard Group

• 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

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-13
• Primary Completion: 2015-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-16
• Study Completion: 2025-05

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

Arm && Interventions

Group	Intervention	Description
Control Group	Control Group	Randomised study to either Bioguard or control stock
Bioguard Group	Bioguard Group	Randomised study to either Bioguard or control stock

Primary Outcome Measures

Name	Time	Method
Change in normalised peri-implant BMD as measured by DXA	6 months post operative

Trial Locations

Locations (1)

RJAH; 🇬🇧 Oswestry, United Kingdom