Retrospective Simplex High Viscosity (HV) Bone Cement Study

NCT05659329 | Completed Results FDA Device

• 1 other identifier: 80
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Arthritis Knee; Aseptic Loosening

Keywords

Bone Cement; Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (7)

• Knee Society Score (KSS) Pain Motion Score: Range of Motion

  pre-op, 2 years, 5 years (optional)

• KSS Pain Motion Score: Pain

  Pre-operative, 2 years, 5 years (optional)

• KSS Function Score: Walking Aids

  Pre-operative, 2 years, 5 years (optional)

• KSS Function Score: Walking

  pre-operative, 2 years, 5 years (optional)

• KSS Function Score: Stairs

  Pre-operative, 2 years, 5 years (optional)

Study Arms (2)

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/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.

Device: Simplex HV/Gentamicin Simplex HV bone cement

Interventions

Simplex HV/Gentamicin Simplex HV bone cement DEVICE

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.

Gentamicin Simplex HV; Non-medicated Simplex HV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Limitations and Caveats

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.

Results Point of Contact

• Title: Britta von den Brincken
• Organization: Stryker

britta.vondenbrincken@stryker.com

+491638999202

Study Officials

• Andrew Toms, Prof.

  PEOC Royal Devon & Exeter Hospital

  PRINCIPAL INVESTIGATOR

• Matthew Hepinstall, MD

  Department of Orthopedic Surgery NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: April 25, 2016
• Primary Completion: September 27, 2022
• Study Completion: September 27, 2022
• Last Updated: January 12, 2026
• Results First Posted: January 12, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share