MedDataX Logo

Trial Outcomes & Findings for Maxim® Knee Pop-Top® Tibia vs. Regular Maxim® Knee Tibia (NCT NCT00579059)

NCT ID: NCT00579059

Last Updated: 2017-07-17

Results Overview

The function score is detailed below as a Range; 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent," 60-89 is considered "Good," 30-59 is considered "fair," and 0-29 is considered "poor."

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

1 Year

Results posted on

2017-07-17

Participant Flow

Patients were recruited by the investigator.

There were no pre-assignment details to report.

Participant milestones

Participant milestones
Measure
Maxim® Pop-Top® Tibia
tibia with removable polyethylene
Maxim® Regular Tibia
Tibia with Modular Polyethylene
Overall Study
STARTED
21
10
Overall Study
Immediate Post-Op
20
9
Overall Study
6 Months
11
4
Overall Study
1 Year
8
3
Overall Study
3 Years
0
0
Overall Study
5 Years
0
0
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
21
10

Reasons for withdrawal

Reasons for withdrawal
Measure
Maxim® Pop-Top® Tibia
tibia with removable polyethylene
Maxim® Regular Tibia
Tibia with Modular Polyethylene
Overall Study
Study Canceled at 1 Year
21
10

Baseline Characteristics

Maxim® Knee Pop-Top® Tibia vs. Regular Maxim® Knee Tibia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Maxim® Pop-Top® Tibia
n=21 Participants
tibia with removable polyethylene
Maxim® Regular Tibia
n=10 Participants
Tibia with Modular Polyethylene
Total
n=31 Participants
Total of all reporting groups
Age, Continuous
68 years
FULL_RANGE 8 • n=5 Participants
62 years
FULL_RANGE 6 • n=7 Participants
65 years
n=5 Participants
Sex: Female, Male
Female
17 Participants
n=5 Participants
5 Participants
n=7 Participants
22 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
5 Participants
n=7 Participants
9 Participants
n=5 Participants
Region of Enrollment
United States
21 participants
n=5 Participants
10 participants
n=7 Participants
31.0 participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 Year

Population: This population represents patients that returned for follow-up at 1-year post-op per protocol.

The function score is detailed below as a Range; 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent," 60-89 is considered "Good," 30-59 is considered "fair," and 0-29 is considered "poor."

Outcome measures

Outcome measures
Measure
Maxim® Pop-Top® Tibia
n=8 Participants
tibia with removable polyethylene
Maxim® Regular Tibia
n=3 Participants
Tibia with Modular Polyethylene
Knee Society Function Score
90-100
6 knees
2 knees
Knee Society Function Score
60-89
2 knees
1 knees
Knee Society Function Score
30-59
0 knees
0 knees
Knee Society Function Score
0-29
0 knees
0 knees

SECONDARY outcome

Timeframe: 1 Year

Population: This population represents patients that returned for follow-up at 1-year post-op per protocol.

This represents how far the patients were able to flex the knee in the clinic at 1-year.

Outcome measures

Outcome measures
Measure
Maxim® Pop-Top® Tibia
n=8 Participants
tibia with removable polyethylene
Maxim® Regular Tibia
n=3 Participants
Tibia with Modular Polyethylene
Range of Motion - Flexion
118 degrees
Interval 100.0 to 130.0
113 degrees
Interval 105.0 to 120.0

Adverse Events

Maxim® Pop-Top® Tibia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Maxim® Regular Tibia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Megan Lawson, Clinical Research Specialist

Biomet, LLC

Phone: 1-800-348-9500

Results disclosure agreements

  • Principal investigator is a sponsor employee Biomet owns copyright to database.
  • Publication restrictions are in place

Restriction type: OTHER