Trial Outcomes & Findings for A Study to Compare the NexGen LPS and LPS-Flex Knee Implants (NCT NCT00763386)
NCT ID: NCT00763386
Last Updated: 2012-06-04
Results Overview
Postoperative ROM was calculated by taking the measurement of patient flexion minus the measurement of patients' extension.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
331 participants
Primary outcome timeframe
6 Weeks to 2 Years Post-op, based on on the intervals listed
Results posted on
2012-06-04
Participant Flow
Patients were enrolled between June 2001 and December 2007 at a total of 12 sites throughout the US/Canada
Participant milestones
| Measure |
LPS Flex Fixed Bearing Knee
Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
|
LPS Standard Knee
Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
|
|---|---|---|
|
Overall Study
STARTED
|
164
|
167
|
|
Overall Study
COMPLETED
|
116
|
127
|
|
Overall Study
NOT COMPLETED
|
48
|
40
|
Reasons for withdrawal
| Measure |
LPS Flex Fixed Bearing Knee
Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
|
LPS Standard Knee
Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
|
|---|---|---|
|
Overall Study
Adverse Event
|
43
|
33
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
CRF missing
|
0
|
1
|
|
Overall Study
Study Prosthesis Removed
|
1
|
0
|
Baseline Characteristics
A Study to Compare the NexGen LPS and LPS-Flex Knee Implants
Baseline characteristics by cohort
| Measure |
LPS Flex Fixed Bearing Knee
n=164 Participants
Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
|
LPS Standard Knee
n=167 Participants
Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
|
Total
n=331 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Categorical
<=18 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Age Categorical
Between 18 and 65 years
|
83 participants
n=99 Participants
|
82 participants
n=107 Participants
|
165 participants
n=206 Participants
|
|
Age Categorical
>=65 years
|
81 participants
n=99 Participants
|
84 participants
n=107 Participants
|
165 participants
n=206 Participants
|
|
Age Continuous
|
64.6 years
STANDARD_DEVIATION 8.1 • n=99 Participants
|
64.9 years
STANDARD_DEVIATION 8.4 • n=107 Participants
|
64.7 years
STANDARD_DEVIATION 8.3 • n=206 Participants
|
|
Gender
Female
|
92 participants
n=99 Participants
|
84 participants
n=107 Participants
|
176 participants
n=206 Participants
|
|
Gender
Male
|
72 participants
n=99 Participants
|
82 participants
n=107 Participants
|
154 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
133 participants
n=99 Participants
|
138 participants
n=107 Participants
|
271 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
31 participants
n=99 Participants
|
29 participants
n=107 Participants
|
60 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 Weeks to 2 Years Post-op, based on on the intervals listedPopulation: Analysis was determined by calculating the measurements of the enrolled cases who completed the stated visit interval.
Postoperative ROM was calculated by taking the measurement of patient flexion minus the measurement of patients' extension.
Outcome measures
| Measure |
LPS Flex Fixed Bearing Knee
n=164 Participants
Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
|
LPS Standard Knee
n=167 Participants
Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
|
|---|---|---|
|
Postoperative Range of Motion (ROM)
PostOp ROM @ 6 Weeks
|
102.3 degrees
Standard Deviation 17.1
|
106.8 degrees
Standard Deviation 13.9
|
|
Postoperative Range of Motion (ROM)
PostOp ROM @ 6 Months
|
117.6 degrees
Standard Deviation 11.3
|
118.2 degrees
Standard Deviation 12.1
|
|
Postoperative Range of Motion (ROM)
PostOp ROM @1 Year
|
120.3 degrees
Standard Deviation 10.7
|
121.7 degrees
Standard Deviation 10.4
|
|
Postoperative Range of Motion (ROM)
PostOp ROM @2 Year
|
120.7 degrees
Standard Deviation 10.7
|
121.2 degrees
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: 6 Weeks to 2 Years Post-op, based on on the intervals listedScores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals. Grading for the Knee Society Score is based on a scale from 0-100 and results are established follows: 80-100 =Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor.
Outcome measures
| Measure |
LPS Flex Fixed Bearing Knee
n=164 Participants
Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
|
LPS Standard Knee
n=167 Participants
Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
|
|---|---|---|
|
Return to Function (RtF) Via Knee Society Score (Modified)
PostOp KSSF @ 6 Week
|
56.4 units on a scale
Standard Deviation 21.7
|
58.5 units on a scale
Standard Deviation 19.8
|
|
Return to Function (RtF) Via Knee Society Score (Modified)
PostOp KSSF @ 6 Month
|
79.2 units on a scale
Standard Deviation 19.5
|
79.7 units on a scale
Standard Deviation 20.0
|
|
Return to Function (RtF) Via Knee Society Score (Modified)
PostOp KSSF @ 1 Year
|
81.1 units on a scale
Standard Deviation 21.9
|
81.7 units on a scale
Standard Deviation 19.5
|
|
Return to Function (RtF) Via Knee Society Score (Modified)
PostOp KSSF @ 2 Year
|
84.3 units on a scale
Standard Deviation 18.9
|
83.1 units on a scale
Standard Deviation 18.9
|
Adverse Events
LPS Flex Fixed Bearing Knee
Serious events: 13 serious events
Other events: 27 other events
Deaths: 0 deaths
LPS Standard Knee
Serious events: 19 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LPS Flex Fixed Bearing Knee
n=164 participants at risk
Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
|
LPS Standard Knee
n=167 participants at risk
Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
0.61%
1/164 • Number of events 1 • Overall Study
|
1.2%
2/167 • Number of events 2 • Overall Study
|
|
General disorders
Death
|
0.61%
1/164 • Number of events 1 • Overall Study
|
1.2%
2/167 • Number of events 2 • Overall Study
|
|
Musculoskeletal and connective tissue disorders
Other Knee Related Complication (Musculoskeletal and Connective Tissue Disorders)
|
—
0/0 • Overall Study
|
0.60%
1/167 • Number of events 1 • Overall Study
|
|
Musculoskeletal and connective tissue disorders
Stiff Knee Resulting in Manipulation
|
0.61%
1/164 • Number of events 1 • Overall Study
|
1.2%
2/167 • Number of events 2 • Overall Study
|
|
Musculoskeletal and connective tissue disorders
Other General Complications (Musculoskeletal and Connective Tissue Disorder)
|
3.0%
5/164 • Number of events 6 • Overall Study
|
4.2%
7/167 • Number of events 10 • Overall Study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other General Complications (Neoplasms benign, malignant and unspecified)
|
1.2%
2/164 • Number of events 2 • Overall Study
|
0.60%
1/167 • Number of events 1 • Overall Study
|
|
Cardiac disorders
Cardiac Arrhythmia
|
0.61%
1/164 • Number of events 1 • Overall Study
|
0.00%
0/167 • Overall Study
|
|
Cardiac disorders
Congestive Heart Failure
|
0.61%
1/164 • Number of events 1 • Overall Study
|
0.00%
0/167 • Overall Study
|
|
Cardiac disorders
Myocardial Infarction
|
0.61%
1/164 • Number of events 1 • Overall Study
|
0.00%
0/167 • Overall Study
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral Subluxation
|
0.61%
1/164 • Number of events 1 • Overall Study
|
0.00%
0/167 • Overall Study
|
|
Musculoskeletal and connective tissue disorders
Quad Tendon Rupture
|
0.61%
1/164 • Number of events 1 • Overall Study
|
0.00%
0/167 • Overall Study
|
|
Renal and urinary disorders
Other General Complication (Renal and Urinary Disorders)
|
0.61%
1/164 • Number of events 1 • Overall Study
|
0.60%
1/167 • Number of events 1 • Overall Study
|
|
Surgical and medical procedures
Other General Complication (Surgical and Medical Procedures)
|
0.61%
1/164 • Number of events 1 • Overall Study
|
0.60%
1/167 • Number of events 1 • Overall Study
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.61%
1/164 • Number of events 1 • Overall Study
|
0.00%
0/167 • Overall Study
|
|
Ear and labyrinth disorders
Other General Complication (Ear and Labyrthinth Disorders)
|
0.00%
0/164 • Overall Study
|
0.60%
1/167 • Number of events 1 • Overall Study
|
|
Endocrine disorders
Other General Complication (Endocrine Disorders)
|
0.00%
0/164 • Overall Study
|
0.60%
1/167 • Number of events 1 • Overall Study
|
|
Musculoskeletal and connective tissue disorders
Patellar Implant Loosening
|
0.00%
0/164 • Overall Study
|
0.60%
1/167 • Number of events 1 • Overall Study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other Knee Related Complication (Neoplasms benign, malignant and unspecified)
|
0.00%
0/164 • Overall Study
|
0.60%
1/167 • Number of events 1 • Overall Study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Infection
|
0.00%
0/164 • Overall Study
|
0.60%
1/167 • Number of events 1 • Overall Study
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.61%
1/164 • Number of events 1 • Overall Study
|
0.00%
0/167 • Overall Study
|
Other adverse events
| Measure |
LPS Flex Fixed Bearing Knee
n=164 participants at risk
Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
|
LPS Standard Knee
n=167 participants at risk
Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
|
|---|---|---|
|
Gastrointestinal disorders
Other General Disorders (GI Disorder)
|
1.8%
3/164 • Number of events 6 • Overall Study
|
0.00%
0/167 • Overall Study
|
|
Musculoskeletal and connective tissue disorders
Other General Complication (Musculoskeletal and Connective Tissue Disorder)
|
7.9%
13/164 • Number of events 27 • Overall Study
|
7.2%
12/167 • Number of events 19 • Overall Study
|
|
Musculoskeletal and connective tissue disorders
Other Knee Related Complication
|
1.2%
2/164 • Number of events 2 • Overall Study
|
1.8%
3/167 • Number of events 4 • Overall Study
|
|
Musculoskeletal and connective tissue disorders
Stiff Knee Resulting in Manipulations
|
2.4%
4/164 • Number of events 4 • Overall Study
|
1.2%
2/167 • Number of events 2 • Overall Study
|
|
Renal and urinary disorders
Urinary Tract Infection
|
1.2%
2/164 • Number of events 2 • Overall Study
|
1.8%
3/167 • Number of events 3 • Overall Study
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/164 • Overall Study
|
1.8%
3/167 • Number of events 3 • Overall Study
|
|
Vascular disorders
Other General Complication (Vascular Disorder)
|
1.8%
3/164 • Number of events 3 • Overall Study
|
0.00%
0/167 • Overall Study
|
Additional Information
Kacy Arnold, Associate Director, Clinical Affairs
Zimmer
Phone: 574-371-8336
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place