Trial Outcomes & Findings for Zimmer POLAR - Total Knee Arthroplasty (TKA) (NCT NCT01859130)
NCT ID: NCT01859130
Last Updated: 2023-10-13
Results Overview
This form includes alignment, instability, joint range of motion, and symptoms. The overall range of scores available is -8 to 106. A higher score indicates good alignment, range of motion, and minimal symptoms of pain. A lower score indicates poor knee alignment, potential issues in range of motion, and the likely experience of symptoms of pain.
COMPLETED
NA
299 participants
5 years post op
2023-10-13
Participant Flow
Participant milestones
| Measure |
Persona TKA
Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System
Zimmer Persona Total Knee System
|
|---|---|
|
Overall Study
STARTED
|
299
|
|
Overall Study
COMPLETED
|
192
|
|
Overall Study
NOT COMPLETED
|
107
|
Reasons for withdrawal
| Measure |
Persona TKA
Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System
Zimmer Persona Total Knee System
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Lost to Follow-up
|
16
|
|
Overall Study
Sponsor terminated: 47 Not specified: 3
|
53
|
|
Overall Study
Physician Decision
|
6
|
|
Overall Study
Withdrawal by Subject
|
17
|
|
Overall Study
Adverse Event
|
11
|
Baseline Characteristics
Patient demographics were captured for 326 subjects, however 27 subjects were study completed prior to surgery and prior to pre-op Patient Report Outcome Measure Completion. All other analyses will include 299 subjects (beginning with PROMs).
Baseline characteristics by cohort
| Measure |
Persona TKA
n=299 Participants
Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System
Zimmer Persona Total Knee System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
153 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
146 Participants
n=5 Participants
|
|
Age, Continuous
|
62.88 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
296 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
299 participants
n=5 Participants
|
|
EQ5D-5L
|
0.5 units on a scale
n=5 Participants • Patient demographics were captured for 326 subjects, however 27 subjects were study completed prior to surgery and prior to pre-op Patient Report Outcome Measure Completion. All other analyses will include 299 subjects (beginning with PROMs).
|
|
Knee Society Score - Objective Knee
|
47.3 units on a scale
n=5 Participants • Patient demographics were captured for 326 subjects, however 27 subjects were study completed prior to surgery and prior to pre-op Patient Report Outcome Measure Completion. All other analyses will include 299 subjects (beginning with PROMs).
|
|
KSS Patient Expectations
|
14.4 units on a scale
n=5 Participants • Patient demographics were captured for 326 subjects, however 27 subjects were study completed prior to surgery and prior to pre-op Patient Report Outcome Measure Completion. All other analyses will include 299 subjects (beginning with PROMs).
|
PRIMARY outcome
Timeframe: 5 years post opPopulation: Only 161 subjects completed the KSS form at the final 5yr follow-up. All other subjects were study completed, or lost to follow-up.
This form includes alignment, instability, joint range of motion, and symptoms. The overall range of scores available is -8 to 106. A higher score indicates good alignment, range of motion, and minimal symptoms of pain. A lower score indicates poor knee alignment, potential issues in range of motion, and the likely experience of symptoms of pain.
Outcome measures
| Measure |
Persona TKA
n=161 Participants
Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System
Zimmer Persona Total Knee System
|
|---|---|
|
Knee Society Scores
|
92.9 units on a scale
Interval 57.0 to 102.0
|
SECONDARY outcome
Timeframe: 5 years post opPopulation: Only 175 subjects completed the EQ-5D form at the final 5yr follow-up. All other subjects were study completed, or lost to follow-up.
The EQ-5D family of instruments has been developed to evaluate health across a wide range of disease areas. Each EQ-5D instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS). The questionnaire provides a simple descriptive profile of a respondent's health state. The EQ VAS provides an alternative way to elicit an individual's rating of the individual's own overall current health. The overall range is -0.1 to 1.0. A higher score indicates a better overall health rating reported by the patient, and a lower score indicates a poor overall health rating. It is possible to score a negative value. Although unlikely, a negative value is observed to be a state worse than death.
Outcome measures
| Measure |
Persona TKA
n=175 Participants
Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System
Zimmer Persona Total Knee System
|
|---|---|
|
EQ-5D
|
0.9 units on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 5 years post-opPopulation: Only 176 subjects completed the FJS form at the final 5yr follow-up. All other subjects were study completed, or lost to follow-up.
The Forgotten Joint Score-12 (FJS-12) is a validated patient-reported outcome measure (PROM) tool designed to assess artificial prosthesis awareness during daily activities following total knee arthroplasty (TKA). Scores range from 0-100. A score of 100 would indicate a high degree of "forgetting" the artificial joint (a low degree of awareness). A score of 0 would indicates a very low degree of "forgetting" the artificial joint (typically aware of the replacement).
Outcome measures
| Measure |
Persona TKA
n=176 Participants
Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System
Zimmer Persona Total Knee System
|
|---|---|
|
Forgotten Joint Score (FJS)
|
74.9 units on a scale
Interval 0.0 to 100.0
|
Adverse Events
Persona TKA
Serious adverse events
| Measure |
Persona TKA
n=299 participants at risk
Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System
Zimmer Persona Total Knee System
|
|---|---|
|
Cardiac disorders
Cardiovascular
|
3.7%
11/299 • Number of events 12 • Postoperatively through study completion (5yr follow-up).
|
|
Cardiac disorders
Generic Cardiovascular Reports
|
1.0%
3/299 • Number of events 3 • Postoperatively through study completion (5yr follow-up).
|
|
Skin and subcutaneous tissue disorders
Dermatological Disorders
|
1.0%
3/299 • Number of events 3 • Postoperatively through study completion (5yr follow-up).
|
|
Metabolism and nutrition disorders
Adrenal insufficiency
|
0.33%
1/299 • Number of events 1 • Postoperatively through study completion (5yr follow-up).
|
|
Gastrointestinal disorders
Gastrointestinal
|
1.7%
5/299 • Number of events 5 • Postoperatively through study completion (5yr follow-up).
|
|
Renal and urinary disorders
Genitourinary / Renal
|
1.7%
5/299 • Number of events 5 • Postoperatively through study completion (5yr follow-up).
|
|
Blood and lymphatic system disorders
Hematological
|
0.33%
1/299 • Number of events 1 • Postoperatively through study completion (5yr follow-up).
|
|
Infections and infestations
Infection (non-knee)
|
1.0%
3/299 • Number of events 3 • Postoperatively through study completion (5yr follow-up).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
8.7%
26/299 • Number of events 26 • Postoperatively through study completion (5yr follow-up).
|
|
Nervous system disorders
Neurological
|
2.3%
7/299 • Number of events 8 • Postoperatively through study completion (5yr follow-up).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncological
|
1.0%
3/299 • Number of events 3 • Postoperatively through study completion (5yr follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary / Respiratory
|
2.7%
8/299 • Number of events 8 • Postoperatively through study completion (5yr follow-up).
|
|
Surgical and medical procedures
Wound Drainage / Device Loosening
|
0.67%
2/299 • Number of events 2 • Postoperatively through study completion (5yr follow-up).
|
|
General disorders
Other General Adverse Events
|
3.3%
10/299 • Number of events 12 • Postoperatively through study completion (5yr follow-up).
|
Other adverse events
| Measure |
Persona TKA
n=299 participants at risk
Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System
Zimmer Persona Total Knee System
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal
|
13.7%
41/299 • Number of events 47 • Postoperatively through study completion (5yr follow-up).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
48.5%
145/299 • Number of events 246 • Postoperatively through study completion (5yr follow-up).
|
|
General disorders
Other General Adverse Events
|
39.5%
118/299 • Number of events 180 • Postoperatively through study completion (5yr follow-up).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place