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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05659329
Other study ID # 80
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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