18 and older, any sex, with Osteoarthritis or Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Radiograph Assessment of Progressive Tibial RadiolucenciesPrimary· 2 years
Progressive tibial radiolucency will be derived in accordance with the following definitions:
Absent: No evidence of an increase in either radiolucency extent (number of zones involved) or measured width within a zone.
Present: Presence of either: An increase in the number of zones with a measured tibial radiolucency, OR an increase in the measured tibial radiolucency width within a zone of \>0.5 mm.
Unable to assess: One or more of the component factors necessary to derive progressive tibial radiolucency is unavailable.
Absent
Group
Value
95% CI
Persona TM Tibia
110
Present
Group
Value
95% CI
Persona TM Tibia
4
Unable to assess
Group
Value
95% CI
Persona TM Tibia
3
Oxford Knee ScoreSecondary· 2 years
The Oxford Knee Score is a patient completed 12 question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The maximum score is 48 points (best) and the minimum score is 0 points (worst).
OKS >38
Group
Value
95% CI
Persona TM Tibia
95
OKS <=38
Group
Value
95% CI
Persona TM Tibia
20
Revision RateSecondary· 2 years
Rate of the number of revisions for any reason
Group
Value
95% CI
Persona TM Tibia
146
Persona TM Tibia
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of this study is to evaluate clinical performance for the commercially available Persona TM Tibia used in primary cementless tibia total knee arthroplasty.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Zimmer Biomet
Last refreshed: 23 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03589300.