Retrospective Simplex High Viscosity (HV) Bone Cement Study

Stryker

Status

Completed

Conditions

Arthritis Knee

Aseptic Loosening

Treatments

Device: Simplex HV

Study type

Observational

Funder types

Industry

Identifiers

NCT05659329

Details and patient eligibility

About

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

Full description

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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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