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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2025-05-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Osteoarthritis of Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bioguard Group

Randomised study to either Bioguard or control stock

Group Type EXPERIMENTAL

Bioguard Group

Intervention Type DEVICE

Patients randomised to receive the study investigative device will receive a Bioguard implant

Control Group

Randomised study to either Bioguard or control stock

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type DEVICE

Patients randomised to receive the control device will receive a Exceed Taperlock implant

Interventions

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Bioguard Group

Patients randomised to receive the study investigative device will receive a Bioguard implant

Intervention Type DEVICE

Control Group

Patients randomised to receive the control device will receive a Exceed Taperlock implant

Intervention Type DEVICE

Other Intervention Names

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Bioguard device Exceed Taperlock

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No