search
Back to results

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

Primary Purpose

Osteoarthritis of Hip

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Bioguard Group
Control Group
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of Hip

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • RJAH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bioguard Group

Control Group

Arm Description

Randomised study to either Bioguard or control stock

Randomised study to either Bioguard or control stock

Outcomes

Primary Outcome Measures

Change in normalised peri-implant BMD as measured by DXA

Secondary Outcome Measures

Full Information

First Posted
October 8, 2014
Last Updated
January 24, 2023
Sponsor
Zimmer Biomet
search

1. Study Identification

Unique Protocol Identification Number
NCT02263209
Brief Title
Investigation to Determine Safety of Taperloc Stems With BioGuard Coating When Used in Cementless Total Hip Arthroplasty
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2013 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bioguard Group
Arm Type
Experimental
Arm Description
Randomised study to either Bioguard or control stock
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Randomised study to either Bioguard or control stock
Intervention Type
Device
Intervention Name(s)
Bioguard Group
Other Intervention Name(s)
Bioguard device
Intervention Description
Patients randomised to receive the study investigative device will receive a Bioguard implant
Intervention Type
Device
Intervention Name(s)
Control Group
Other Intervention Name(s)
Exceed Taperlock
Intervention Description
Patients randomised to receive the control device will receive a Exceed Taperlock implant
Primary Outcome Measure Information:
Title
Change in normalised peri-implant BMD as measured by DXA
Time Frame
6 months post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudheer Karlakki, MD
Organizational Affiliation
RJAH, Oswestry
Official's Role
Principal Investigator
Facility Information:
Facility Name
RJAH
City
Oswestry
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs