Clincosm LogoSign in Get a demo

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

Sponsor
Zimmer Biomet (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02263209
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
139
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Bioguard Group
  • Device: Control Group
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Nov 1, 2015
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bioguard Group

Randomised study to either Bioguard or control stock

Device: Bioguard Group
Patients randomised to receive the study investigative device will receive a Bioguard implant
Other Names:
  • Bioguard device

    		•
    Active Comparator: Control Group

    Randomised study to either Bioguard or control stock

    Device: Control Group
    Patients randomised to receive the control device will receive a Exceed Taperlock implant
    Other Names:
  • Exceed Taperlock

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in normalised peri-implant BMD as measured by DXA [6 months post operative]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 RJAH Oswestry United Kingdom

    Sponsors and Collaborators

    • Zimmer Biomet

    Investigators

    • Principal Investigator: Sudheer Karlakki, MD, RJAH, Oswestry

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zimmer Biomet
    ClinicalTrials.gov Identifier:
    NCT02263209
    Other Study ID Numbers:
    • BMETEU.CR.EU77
    First Posted:
    Oct 13, 2014
    Last Update Posted:
    Jan 20, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Osteoarthritis, Hip

    Study Results

    No Results Posted as of Jan 20, 2022