Trial Outcomes & Findings for Persona TM Tibia Clinical Outcomes Study (NCT NCT03589300)

Last Updated: 2024-07-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

148 participants

Primary outcome timeframe

2 years

Results posted on

2024-07-23

Participant Flow

Unit of analysis: Knees

Participant milestones

Participant milestones
Measure	Persona TM Tibia Persona Trabecular Metal (TM) Tibia used in primary cementless total knee arthroplasty
Overall Study STARTED	125 148
Overall Study COMPLETED	102 120
Overall Study NOT COMPLETED	23 28

Reasons for withdrawal

Reasons for withdrawal
Measure	Persona TM Tibia Persona Trabecular Metal (TM) Tibia used in primary cementless total knee arthroplasty
Overall Study Adverse Event	2
Overall Study Death	4
Overall Study Lost to Follow-up	12
Overall Study Withdrawal by Subject	5

Baseline Characteristics

Persona TM Tibia Clinical Outcomes Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Persona TM Tibia n=148 Knees Persona Trabecular Metal Tibia used in primary cementless total knee arthroplasty
Age, Continuous	63.28 years STANDARD_DEVIATION 8.93 • n=373 Knees
Sex: Female, Male Female	64 Knees n=373 Knees
Sex: Female, Male Male	84 Knees n=373 Knees
Race/Ethnicity, Customized African American or Black	9 Knees n=373 Knees
Race/Ethnicity, Customized American Indian or Alaska Native	1 Knees n=373 Knees
Race/Ethnicity, Customized Asian	16 Knees n=373 Knees
Race/Ethnicity, Customized Hispanic or Latino	21 Knees n=373 Knees
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Knees n=373 Knees
Race/Ethnicity, Customized White	99 Knees n=373 Knees
Region of Enrollment United States	148 Knees n=373 Knees

PRIMARY outcome

Timeframe: 2 years

Population: 99 participants (117 knees) had radiographs analyzed at the 2 year follow-up interval.

Outcome measures

Outcome measures
Measure	Persona TM Tibia n=117 Knees Persona Trabecular Metal Tibia used in primary cementless total knee arthroplasty
Radiograph Assessment of Progressive Tibial Radiolucencies Absent	110 Knees
Radiograph Assessment of Progressive Tibial Radiolucencies Present	4 Knees
Radiograph Assessment of Progressive Tibial Radiolucencies Unable to assess	3 Knees

SECONDARY outcome

Timeframe: 2 years

Population: 97 participants (115 knees) completed the Oxford Knee Score (OKS) at the 2 year follow-up interval. Literature suggests that Oxford Knee Scores above 41 are considered excellent and scores from 34 to 41 are considered good. The endpoint was designed to distinguish scores above 38. Reference: Murray et al. (2007). The use of the Oxford hip and knee scores. Bone \& Joint Journal, 89(8), 1010-1014

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).

Outcome measures

Outcome measures
Measure	Persona TM Tibia n=115 Knees Persona Trabecular Metal Tibia used in primary cementless total knee arthroplasty
Oxford Knee Score OKS >38	95 Knees
Oxford Knee Score OKS <=38	20 Knees

SECONDARY outcome

Timeframe: 2 years

Population: A revision is when the study implant is removed/revised due to an adverse event. Of the 148 knees that received the Persona TM Tibia implant, there were 2 reported revisions.

Rate of the number of revisions for any reason

Outcome measures

Outcome measures
Measure	Persona TM Tibia n=148 Knees Persona Trabecular Metal Tibia used in primary cementless total knee arthroplasty
Revision Rate Number of knees not revised	146 Knees
Revision Rate Number of knees revised	2 Knees

Adverse Events

Persona TM Tibia

Serious events: 15 serious events

Other events: 69 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Persona TM Tibia n=125 participants at risk Persona Trabecular Metal Tibia used in primary cementless total knee arthroplasty
Skin and subcutaneous tissue disorders Cellulitis/Redness/Blistering	0.80% 1/125 • Number of events 1 • 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.
Surgical and medical procedures Contralateral Knee Replacement (UKA or TKA)	2.4% 3/125 • Number of events 3 • 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.
Infections and infestations Deep Wound Infection	0.80% 1/125 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Effusion/Swelling/Edema	0.80% 1/125 • Number of events 1 • 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.
Endocrine disorders Endocrine	0.80% 1/125 • Number of events 1 • 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.
Gastrointestinal disorders Gastrointestinal	0.80% 1/125 • Number of events 1 • 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.
Blood and lymphatic system disorders Hematological/Abnormal Lab	0.80% 1/125 • Number of events 1 • 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.
Infections and infestations Infection (not study knee)	0.80% 1/125 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal (not study knee)	4.0% 5/125 • Number of events 5 • 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.
Musculoskeletal and connective tissue disorders Pain (progressive/persistent)	0.80% 1/125 • Number of events 1 • 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.
Injury, poisoning and procedural complications Traumatic Injury (not study knee)	2.4% 3/125 • Number of events 3 • 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.

Other adverse events

Other adverse events
Measure	Persona TM Tibia n=125 participants at risk Persona Trabecular Metal Tibia used in primary cementless total knee arthroplasty
Cardiac disorders Cardiovascular	4.8% 6/125 • Number of events 6 • 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.
Skin and subcutaneous tissue disorders Cellulitis/Redness/Blistering	0.80% 1/125 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Clicking/Popping/Crepitus/Grinding	3.2% 4/125 • Number of events 4 • 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.
Surgical and medical procedures Contralateral Knee Replacement (UKA or TKA)	4.8% 6/125 • Number of events 6 • 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.
Infections and infestations Deep Wound Infection	0.80% 1/125 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Dermatological	2.4% 3/125 • Number of events 3 • 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.
Musculoskeletal and connective tissue disorders Effusion/Swelling/Edema	0.80% 1/125 • Number of events 1 • 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.
Endocrine disorders Endocrine	2.4% 3/125 • Number of events 3 • 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.
Musculoskeletal and connective tissue disorders Femoral Fracture	1.6% 2/125 • Number of events 2 • 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.
Gastrointestinal disorders Gastrointestinal	2.4% 3/125 • Number of events 3 • 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.
Renal and urinary disorders Genitourinary/Renal	4.0% 5/125 • Number of events 5 • 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.
Blood and lymphatic system disorders Hematological/Abnormal Lab	2.4% 3/125 • Number of events 3 • 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.
Infections and infestations Infection (not study knee)	1.6% 2/125 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal (not study knee)	24.8% 31/125 • Number of events 36 • 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.
Nervous system disorders Neurological	3.2% 4/125 • Number of events 4 • 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.
General disorders Other General Adverse Event	4.0% 5/125 • Number of events 5 • 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.
Musculoskeletal and connective tissue disorders Other Ipsilateral Knee Related Adverse Event	2.4% 3/125 • Number of events 3 • 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.
Musculoskeletal and connective tissue disorders Pain (progressive/persistent)	10.4% 13/125 • Number of events 13 • 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.
Musculoskeletal and connective tissue disorders Patellar Fracture	0.80% 1/125 • Number of events 1 • 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.
Psychiatric disorders Psychological	1.6% 2/125 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Pulmonary/Respiratory	0.80% 1/125 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Stiffness/Limited ROM (progress/persistent)	8.0% 10/125 • Number of events 10 • 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.
Injury, poisoning and procedural complications Traumatic Injury (not study knee)	2.4% 3/125 • Number of events 3 • 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.
Injury, poisoning and procedural complications Traumatic Injury (study knee)	2.4% 3/125 • Number of events 3 • 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.
Skin and subcutaneous tissue disorders Wound Dehiscence	0.80% 1/125 • Number of events 1 • 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.

Additional Information

Director of Clinical Operations

Zimmer Biomet

Phone: 800-613-6131

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place