Retrospective Simplex High Viscosity (HV) Bone Cement Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-25

Study Completion Date

2022-09-27

Brief Summary

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This study is a retrospective multicenter study to review the use of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty

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Detailed Description

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This study is a retrospective investigation of subjects who have received primary Triathlon Total Knee Arthroplasty inserted with Simplex High Viscosity (HV) Cement to evaluate the success rate defined as absence of revision for aseptic loosening of components at two years postoperative.

Conditions

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Arthritis Knee Aseptic Loosening

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Non-medicated Simplex HV

Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.

Simplex HV/Gentamicin Simplex HV bone cement

Intervention Type DEVICE

Simplex HV bone cement is a fast-setting acrylic resin for use in bone surgery.

Simplex HV bone cement with Gentamicin is a fast setting acrylic resin with addition of gentamicin sulfate for use in bone surgery.

Mixing two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.

Gentamicin Simplex HV

Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamicin Simplex HV Bone Cement.

Simplex HV/Gentamicin Simplex HV bone cement

Intervention Type DEVICE

Simplex HV bone cement is a fast-setting acrylic resin for use in bone surgery.

Simplex HV bone cement with Gentamicin is a fast setting acrylic resin with addition of gentamicin sulfate for use in bone surgery.

Mixing two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.

Interventions

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Simplex HV/Gentamicin Simplex HV bone cement

Simplex HV bone cement is a fast-setting acrylic resin for use in bone surgery.

Simplex HV bone cement with Gentamicin is a fast setting acrylic resin with addition of gentamicin sulfate for use in bone surgery.

Mixing two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The Patient is age 18 or over at time of study device implantation
* Patients who have undergone primary Triathlon Total Knee Arthroplasty in which Simplex HV/Simplex HV Gentamicin was indicated for fixation and used on label
* Patients who have been followed for at least 24 months postoperatively

Exclusion Criteria

* Patients who have undergone revision surgery
* Patients who have undergone bilateral Knee Arthroplasty
* Patients contraindicated for either the devices implanted, or the cement used, according to medical history review and instructions for use
* Patient has a cementless tibial baseplate.
* Patient has an active or suspected latent infection in or about the affected knee joint
* Patient has muscle loss or neuromuscular impairment in the affected limb that would create an unjustifiable risk
* Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days)
* Patient has a known hypersensitivity to any of the cements constituents or in patients with severe renal failure
* Patient is a prisoner

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No