Retrospective Simplex High Viscosity (HV) Bone Cement Study

Sponsor

Stryker Orthopaedics (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05659329

Collaborator

(none)

200

Enrollment

81.2

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Arthritis Knee Aseptic Loosening	Device: Simplex HV

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Apr 25, 2016

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Non-medicated Simplex HV Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.	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. Other Names: Non-medicated Simplex HV Gentamycin Simplex HV
Gentamycin Simplex HV Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamycin Simplex HV Bone Cement.	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. Other Names: Non-medicated Simplex HV Gentamycin Simplex HV

Arm

Intervention/Treatment

Non-medicated Simplex HV

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

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.

Other Names:

Non-medicated Simplex HV

Gentamycin Simplex HV

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

Device: Simplex HV

Other Names:

Non-medicated Simplex HV

Gentamycin Simplex HV

Outcome Measures

Primary Outcome Measures

Success rate [24 months]
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.

Secondary Outcome Measures

Knee Society Score (KSS) Results [pre-op, 2 years, optional 5 years]
To review KSS results and complications of patients who have received Simplex HV in a Triathlon Total Knee Arthroplasty.
Oxford Knee Score (OKS) Results [pre-op, 2 years, optional 5 years]
To review OKS results and complications of patients who have received Simplex HV in a Triathlon Total Knee Arthroplasty.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Stryker Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stryker Orthopaedics

ClinicalTrials.gov Identifier:

NCT05659329

Other Study ID Numbers:

First Posted:

Dec 21, 2022

Last Update Posted:

Dec 21, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Stryker Orthopaedics

Bone Cement

Knee Arthroplasty

Additional relevant MeSH terms:

Arthritis

Gentamicins

Study Results

No Results Posted as of Dec 21, 2022