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

Osteoarthritis of Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02263209
• Other study ID #: BMETEU.CR.EU77
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2013
• Est. completion date: May 2025

Study information

• Verified date: January 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: May 2025
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis of Hip
• Osteoarthritis, Hip

Intervention

Device:
• Bioguard Group
Patients randomised to receive the study investigative device will receive a Bioguard implant
• Control Group
Patients randomised to receive the control device will receive a Exceed Taperlock implant

Locations

Country	Name	City	State
United Kingdom	RJAH	Oswestry

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in normalised peri-implant BMD as measured by DXA		6 months post operative