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

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ClinicalTrials.gov Identifier: NCT00579059
Recruitment Status : Terminated (The study sponsor canceled the study.)
First Posted : December 21, 2007
Results First Posted : July 7, 2009
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Interventions Device: Maxim® Knee System with Removable Molded Polyethylene Tibia
Device: Regular Maxim® Knee System
Enrollment 31
Recruitment Details Patients were recruited by the investigator.
Pre-assignment Details There were no pre-assignment details to report.
Arm/Group Title Maxim® Pop-Top® Tibia Maxim® Regular Tibia
Hide Arm/Group Description tibia with removable polyethylene Tibia with Modular Polyethylene
Period Title: Overall Study
Started 21 [1] 10 [1]
Immediate Post-Op 20 [2] 9 [2]
6 Months 11 [3] 4 [4]
1 Year 8 [5] 3 [6]
3 Years 0 [7] 0 [7]
5 Years 0 [7] 0 [7]
Completed 0 [8] 0 [8]
Not Completed 21 10
Reason Not Completed
Study Canceled at 1 Year             21             10
[1]
Enrollment was incomplete due to study cancellation.
[2]
1 Patient didn't return for follow-up.
[3]
10 Patients didn't return for follow-up.
[4]
6 patients didn't return for follow-up.
[5]
13 patients didn't return for follow-up.
[6]
7 patients didn't return for follow-up.
[7]
Incomplete due to study closure at 1-year of follow-up.
[8]
No Patients completed through 5 years due to study closure at 1-year of follow-up.
Arm/Group Title Maxim® Pop-Top® Tibia Maxim® Regular Tibia Total
Hide Arm/Group Description tibia with removable polyethylene Tibia with Modular Polyethylene Total of all reporting groups
Overall Number of Baseline Participants 21 10 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants 10 participants 31 participants
68
(53 to 82)
62
(54 to 75)
65
(53 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 10 participants 31 participants
Female
17
  81.0%
5
  50.0%
22
  71.0%
Male
4
  19.0%
5
  50.0%
9
  29.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 10 participants 31 participants
21 10 31
1.Primary Outcome
Title Knee Society Function Score
Hide Description 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."
Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This population represents patients that returned for follow-up at 1-year post-op per protocol.
Arm/Group Title Maxim® Pop-Top® Tibia Maxim® Regular Tibia
Hide Arm/Group Description:
tibia with removable polyethylene
Tibia with Modular Polyethylene
Overall Number of Participants Analyzed 8 3
Measure Type: Number
Unit of Measure: knees
90-100 6 2
60-89 2 1
30-59 0 0
0-29 0 0
2.Secondary Outcome
Title Range of Motion - Flexion
Hide Description This represents how far the patients were able to flex the knee in the clinic at 1-year.
Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This population represents patients that returned for follow-up at 1-year post-op per protocol.
Arm/Group Title Maxim® Pop-Top® Tibia Maxim® Regular Tibia
Hide Arm/Group Description:
tibia with removable polyethylene
Tibia with Modular Polyethylene
Overall Number of Participants Analyzed 8 3
Mean (Full Range)
Unit of Measure: degrees
118
(100 to 130)
113
(105 to 120)
Time Frame Not applicable - no adverse events were reported.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Maxim® Pop-Top® Tibia Maxim® Regular Tibia
Hide Arm/Group Description tibia with removable polyethylene Tibia with Modular Polyethylene
All-Cause Mortality
Maxim® Pop-Top® Tibia Maxim® Regular Tibia
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Maxim® Pop-Top® Tibia Maxim® Regular Tibia
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Maxim® Pop-Top® Tibia Maxim® Regular Tibia
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/10 (0.00%) 
Study was terminated after enrollment failed to produce sufficient data to be analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Biomet owns copyright to database.
Results Point of Contact
Name/Title: Megan Lawson, Clinical Research Specialist
Organization: Biomet, LLC
Phone: 1-800-348-9500 ext 1183
Responsible Party: Zimmer Biomet ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00579059     History of Changes
Other Study ID Numbers: 62-U-007
First Submitted: December 17, 2007
First Posted: December 21, 2007
Results First Submitted: May 20, 2009
Results First Posted: July 7, 2009
Last Update Posted: July 17, 2017