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Completed

NCT Number: NCT05659329

Retrospective Simplex High Viscosity (HV) Bone Cement Study

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

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Key information

Conditions

Arthritis Knee Aseptic Loosening

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Knee Society Score (KSS) Pain Motion Score: Range of Motion

    Time frame: pre-op, 2 years, 5 years (optional)

    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).

  2. KSS Pain Motion Score: Pain

    Time frame: Pre-operative, 2 years, 5 years (optional)

    This section shows a five-level pain measurement from "no pain" to "severe pain" reported by the subjects.

  3. KSS Function Score: Walking Aids

    Time frame: Pre-operative, 2 years, 5 years (optional)

    Pre- and postoperative use of walking aids

  4. KSS Function Score: Walking

    Time frame: pre-operative, 2 years, 5 years (optional)

    Pre- and post-operative walking ability

  5. KSS Function Score: Stairs

    Time frame: Pre-operative, 2 years, 5 years (optional)

    Pre-and postoperative ability of climbing stairs

  6. Oxford Knee Score (OKS) Results

    Time frame: pre-op, 2 years, 5 years (optional)

    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.

  7. KSS Pain Motion Score: Stability

    Time frame: pre-operative, 2 years, 5 years (optional)

    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.

Sponsors and collaborators

Lead sponsor

Stryker Orthopaedics

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Dec 21, 2022
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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