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In this study the investigators propose to monitor subjects who have received Triathlon total knee components inserted with HV cement. The primary outcome will be fixation of the tibial implant component as assessed with RSA and to determine the functionality of patients after surgery using self-reported questionnaires. This is a historical control study, comparing the study cohort to a previous group with Triathlon implants and the long-standing Simplex T cement. The secondary outcomes are inducible displacements of the implants as well as a qualitative evaluation of the cement handling characteristics performed by the operating room staff.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HV Cement | Experimental | Simplex High Viscosity Bone Cement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simplex High Viscosity Bone Cement | Device | high viscosity bone cement for total knee replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant Migration measured with Radiostereometric Analysis (RSA) | Total implant migration will be measured in mm using RSA | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative handling characteristics captured through semi-structured interviews | A qualitative methodology will be used to perform content analysis of the audio from the interviews stored in computer-assisted qualitative data analysis software. The content analysis will involve the use of a deductive approach to the interviews. The coding strategies will derived from a predetermined list of important qualities of bone cement and common themes will be identified as important for the usability of the new cement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Dunbar, PhD | Nova Scotia Health Authority | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Scotia Health Authority | Halifax | Nova Scotia | B3H 3A7 | Canada |
Local ethics approval does not permit sharing of individual participant data
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| intra-operative |