Arthritis KneeNCT05659329

Retrospective Simplex High Viscosity (HV) Bone Cement Study

An observational study of Arthritis Knee and Aseptic Loosening, run by Stryker Orthopaedics.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthritis Knee, Aseptic Loosening
What is being tested?: Simplex HV/Gentamicin Simplex HV bone cement
Type of treatment: Medical device
How many people: 200 participants
Where: No sites listed yet
Study dates: 25 Apr 2016to 27 Sep 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The study population will include all non-censored subjects who have received the Triathlon total knee system cemented with Simplex HV and are available for objective analysis.

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

About this study

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

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

Read the 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.

Conditions: Arthritis Knee, Aseptic Loosening
Being tested: Simplex HV/Gentamicin Simplex HV bone cement
Keywords: Bone Cement, Knee Arthroplasty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT05659329
Study group	Role	What they receive
Non-medicated Simplex HV		Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement. Receives: Device: Simplex HV/Gentamicin Simplex HV bone cement
Gentamicin Simplex HV		Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamicin Simplex HV Bone Cement. Receives: Device: Simplex HV/Gentamicin Simplex HV bone cement

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24 months

Secondary outcomes (7)

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).
Measured: 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.
Measured: Pre-operative, 2 years, 5 years (optional)
KSS Function Score: Walking Aids
Pre- and postoperative use of walking aids
Measured: Pre-operative, 2 years, 5 years (optional)
KSS Function Score: Walking
Pre- and post-operative walking ability
Measured: pre-operative, 2 years, 5 years (optional)
KSS Function Score: Stairs
Pre-and postoperative ability of climbing stairs
Measured: 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.
Measured: pre-op, 2 years, 5 years (optional)
KSS Pain Motion Score: Stability
This section shows number of patients with a minor knee ligament laxity. Antero-posterior (a/p) stability < 5 mm and medio-lateral (m/l) stability < 5° means mild increase in laxity compared to the contralateral knee.
Measured: pre-operative, 2 years, 5 years (optional)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 201627 Sep 2022

First posted21 Dec 2022
Study start25 Apr 2016
Primary completion27 Sep 2022
Study completion27 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Arthritis KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05659329
Sponsor's protocol ID: 80
Status last verified: Jul 2025
First submitted: 13 Dec 2022
Last updated: 12 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: not planned

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Arthritis Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Retrospective Multicenter Study to Review the Use of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT05659329
Acronym / sponsor ID: 80
Conditions: Arthritis Knee, Aseptic Loosening
Keywords: Bone Cement, Knee Arthroplasty
Study type: Observational
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Stryker OrthopaedicsIndustry (pharma, biotech, devices)
Study start: 25 Apr 2016 (actual)
Primary completion: 27 Sep 2022 (actual)
Study completion: 27 Sep 2022 (actual)
First posted: 21 Dec 2022 (actual)
Results: Posted 12 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Non-medicated Simplex HV	–	Device: Simplex HV/Gentamicin Simplex HV bone cementRetrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement.
Gentamicin Simplex HV	–	Device: Simplex HV/Gentamicin Simplex HV bone cementRetrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamicin Simplex HV Bone Cement.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population will include all non-censored subjects who have received the Triathlon total knee system cemented with Simplex HV and are available for objective analysis.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Simplex HV/Gentamicin Simplex HV bone cementSimplex 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.	Device	Gentamicin Simplex HV, Non-medicated Simplex HV

Primary outcome

Number of Participants With Successful Application of Bone Cement
Time frame: 24 months
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.

7 secondary outcomes

Knee Society Score (KSS) Pain Motion Score: Range of Motion
Time frame: pre-op, 2 years, 5 years (optional)
KSS Pain Motion Score: Pain
Time frame: Pre-operative, 2 years, 5 years (optional)
KSS Function Score: Walking Aids
Time frame: Pre-operative, 2 years, 5 years (optional)
KSS Function Score: Walking
Time frame: pre-operative, 2 years, 5 years (optional)
KSS Function Score: Stairs
Time frame: Pre-operative, 2 years, 5 years (optional)
Oxford Knee Score (OKS) Results
Time frame: pre-op, 2 years, 5 years (optional)
KSS Pain Motion Score: Stability
Time frame: pre-operative, 2 years, 5 years (optional)

Results and safety

Results posted to the registry on 12 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-medicated Simplex HV	95	95
Gentamicin Simplex HV	101	101

Primary outcome: Number of Participants With Successful Application of Bone Cement

Time frame: 24 months. Count of participants. Unit: Participants

Measure	Non-medicated Simplex HV n = 95	Gentamicin Simplex HV n = 101
Value	95	101

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-medicated Simplex HV	10 of 95 (10.5%)	18 of 95 (18.9%)	0 of 95
Gentamicin Simplex HV	21 of 101 (20.8%)	9 of 101 (8.9%)	0 of 101

Limitations and caveats (from the sponsor): The retrospective study approach did not allow for full KSS data collection. Data available were collected for analysis. In the retrospective data collection of this study, for some subjects were either no data or 2 years, respective 5 years data available. 5 years data are not mandatorily a consecutive follow-up of the 2 years data of the same subject. OKS was available for one site only.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. not planned

Related trials for Arthritis Knee

Not yet recruiting
Study Comparing Osteoarthritis Programs
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Recruiting
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RecruitingObservational study
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew Toms, Prof. principal investigator

PEOC Royal Devon & Exeter Hospital

Matthew Hepinstall, MD principal investigator

Department of Orthopedic Surgery NYU Langone Health

Questions about this trial

What is this clinical trial studying?

An observational study of Arthritis Knee and Aseptic Loosening, run by Stryker Orthopaedics.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Successful Application of Bone Cement (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05659329.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.