Retrospective Simplex High Viscosity (HV) Bone Cement Study

Arthritis Knee Clinical Trial

Official title:

A Retrospective Multicenter Study to Review the Use of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05659329
• Other study ID #: 80
• Status: Completed
• Start date: April 25, 2016
• Est. completion date: September 27, 2022

Study information

• Verified date: April 2023
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 27, 2022
• Est. primary completion date: September 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis Knee
• Aseptic Loosening

Intervention

Device:
• Simplex HV
Simplex HV bone cement is a fast-setting acrylic resin for use in bone surgery. Mixing the 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate	To evaluate the success rate of cemented Triathlon Total Knee components implanted using Simplex high viscosity bone cement (Simplex HV). Success is defined as absence of revision due to aseptic loosening in cemented Triathlon Total Knee components implanted with Simplex HV.	24 months
Secondary	Knee Society Score (KSS) Results	To review KSS results and complications of patients who have received Simplex HV in a Triathlon Total Knee Arthroplasty.	pre-op, 2 years, optional 5 years
Secondary	Oxford Knee Score (OKS) Results	To review OKS results and complications of patients who have received Simplex HV in a Triathlon Total Knee Arthroplasty.	pre-op, 2 years, optional 5 years