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

Zimmer Biomet

Status: Active, not recruiting

Conditions: Osteoarthritis of Hip

Treatments: Device: Control Group; Device: Bioguard Group

Study type: Interventional

Funder types: Industry

Identifiers

NCT02263209

BMETEU.CR.EU77

Details and patient eligibility

About

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

Full 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

Enrollment: 50 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups

Bioguard Group

Experimental group

Description:

Randomised study to either Bioguard or control stock

Treatment:

Device: Bioguard Group

Control Group

Active Comparator group

Description:

Randomised study to either Bioguard or control stock

Treatment:

Device: Control Group