Retrospective Simplex High Viscosity (HV) Bone Cement Study

Stryker Orthopaedics200 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Arthritis Knee Aseptic Loosening

Interventions

Simplex HV/Gentamicin Simplex HV bone cementDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With Successful Application of Bone Cement

A successful application is defined as absence of revision of Triathlon Total Knee components cemented with Simplex high viscosity bone cement (Simplex HV) within outcome measure timeframe.

Time frame: 24 months

Secondary Outcomes

Knee Society Score (KSS) Pain Motion Score: Range of Motion

The Knee range of motion (ROM) is a parameter which is calculating the range of knee extension (the ability to straighten the leg) and knee flexion (ability to bend the leg). A normal range is from 0º extension (completely straight leg) to 130º flexion (fully flexed leg).

Time frame: pre-op, 2 years, 5 years (optional)

KSS Pain Motion Score: Pain

This section shows a five-level pain measurement from "no pain" to "severe pain" reported by the subjects.

Time frame: Pre-operative, 2 years, 5 years (optional)

KSS Function Score: Walking Aids

Pre- and postoperative use of walking aids

Time frame: Pre-operative, 2 years, 5 years (optional)

KSS Function Score: Walking

Pre- and post-operative walking ability

Time frame: pre-operative, 2 years, 5 years (optional)

KSS Function Score: Stairs

Pre-and postoperative ability of climbing stairs

Time frame: Pre-operative, 2 years, 5 years (optional)

Oxford Knee Score (OKS) Results

The OKS is a patient reported outcome measure that consists of 12 questions about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks. On a scale between 0 and 48, low values indicate severe knee problems and high values indicate satisfactory joint function.

Data from ClinicalTrials.gov

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