N/A
N=196
Retrospective Simplex High Viscosity (HV) Bone Cement Study
Arthritis Knee · Aseptic Loosening
Bottom Line
View on ClinicalTrials.gov: NCT05659329 ↗Enrolled (actual)
196
Serious AEs
15.8%
Results posted
Jan 2026
Primary outcome: Primary: Number of Participants With Successful Application of Bone Cement — 95; 101 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Simplex HV/Gentamicin Simplex HV bone cement (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stryker Orthopaedics
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Application of Bone Cement |
95; 101 | — |
| SECONDARY Knee Society Score (KSS) Pain Motion Score: Range of Motion |
108.59; 101.16; 110.48; 110.32; 113.37; 114.81 | — |
| SECONDARY KSS Pain Motion Score: Pain |
0; 1; 11; 0; 34; 6 | — |
| SECONDARY KSS Function Score: Walking Aids |
23; 12; 3; 1; 0; 1 | — |
| SECONDARY KSS Function Score: Walking |
1; 0; 48; 13; 0; 7 | — |
| SECONDARY KSS Function Score: Stairs |
22; 0; 12; 2; 0; 0 | — |
| SECONDARY Oxford Knee Score (OKS) Results |
18.96; 39.27; 39.38 | — |
| SECONDARY KSS Pain Motion Score: Stability |
87; 1; 81; 0; 52; 0 | — |
Summary
This study is a retrospective multicenter study to review the use of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05659329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.