Trial Outcomes & Findings for Evaluation of Patellar Crepitus Following Total Knee Arthroplasty (NCT NCT01340144)
NCT ID: NCT01340144
Last Updated: 2015-03-25
Results Overview
The incidence of patellar crepitus and clunk will be statistically compared between the study (PFC Sigma HP PS TKA) and control (PFC Sigma PS TKA groups). Based on a strength analysis to determine a theoretical reduction in the incidence of patellar crepitus from 5% to 2%, a study group of 625 subjects in both the control and study ggroups will be required. Each group will also be statistically analyzed using the following variables: overall crepitus incidence, incidence of crepitus requiring only non-operative treatment vs. those requiring operative treatment to manage this complication.
Recruitment status
COMPLETED
Target enrollment
1250 participants
Primary outcome timeframe
Two years after TKA (Total Knee Arthroplasty) procedure
Results posted on
2015-03-25
Participant Flow
Participant milestones
| Measure |
PFC Sigma PS TKA (Total Knee Arthroplasty)
One group received primary TKA using the PFC Sigma PS TKA
|
PFC Sigma HP PS TKA (Total Knee Arthroplasty)
One group received primary TKA using the PFC Sigma HP PS TKA.
|
|---|---|---|
|
Overall Study
STARTED
|
625
|
625
|
|
Overall Study
COMPLETED
|
553
|
567
|
|
Overall Study
NOT COMPLETED
|
72
|
58
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Patellar Crepitus Following Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
PFC Sigma PS TKA (Total Knee Arthroplasty)
n=625 Participants
One group received primary TKA using the PFC Sigma PS TKA
|
PFC Sigma HP PS TKA (Total Knee Arthoplasty)
n=625 Participants
One group received primary TKA using the PFC Sigma HP PS TKA.
|
Total
n=1250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 Years
n=5 Participants
|
65.6 Years
n=7 Participants
|
65.6 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
350 Participants
n=5 Participants
|
352 Participants
n=7 Participants
|
702 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
275 Participants
n=5 Participants
|
273 Participants
n=7 Participants
|
548 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
625 participants
n=5 Participants
|
625 participants
n=7 Participants
|
1250 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Two years after TKA (Total Knee Arthroplasty) procedureThe incidence of patellar crepitus and clunk will be statistically compared between the study (PFC Sigma HP PS TKA) and control (PFC Sigma PS TKA groups). Based on a strength analysis to determine a theoretical reduction in the incidence of patellar crepitus from 5% to 2%, a study group of 625 subjects in both the control and study ggroups will be required. Each group will also be statistically analyzed using the following variables: overall crepitus incidence, incidence of crepitus requiring only non-operative treatment vs. those requiring operative treatment to manage this complication.
Outcome measures
| Measure |
PFC Sigma PS TKA (Total Knee Arthroplasty)
n=553 Participants
One group received primary TKA using the PFC Sigma PS TKA
|
PFC Sigma HP PS TKA (Total Knee Arthroplasty)
n=567 Participants
One group received primary TKA using the PFC Sigma HP PS TKA.
|
|---|---|---|
|
Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject.
Operative Crepitus
|
18 participants
|
7 participants
|
|
Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject.
Positive Crepitus
|
78 participants
|
82 participants
|
|
Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject.
Symptomatic Crepitus
|
31 participants
|
24 participants
|
Adverse Events
PFC Sigma PS TKA (Total Knee Arthroplasty)
Serious events: 45 serious events
Other events: 0 other events
Deaths: 0 deaths
PFC Sigma HP PS TKA (Total Knee Arthroplasty)
Serious events: 29 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PFC Sigma PS TKA (Total Knee Arthroplasty)
n=625 participants at risk
One group received primary TKA using the PFC Sigma PS TKA
|
PFC Sigma HP PS TKA (Total Knee Arthroplasty)
n=625 participants at risk
One group received primary TKA using the PFC Sigma HP PS TKA.
|
|---|---|---|
|
Infections and infestations
Failed total knee due to infection
|
0.64%
4/625 • Number of events 4
|
0.16%
1/625 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
0.16%
1/625 • Number of events 1
|
0.00%
0/625
|
|
Musculoskeletal and connective tissue disorders
Failed total knee due to arthrofibrosis
|
0.48%
3/625 • Number of events 3
|
0.00%
0/625
|
|
Musculoskeletal and connective tissue disorders
Failed TKA due to chronic patellofemoral and mild tibiofemoral instability
|
0.16%
1/625 • Number of events 1
|
0.00%
0/625
|
|
General disorders
Death
|
0.96%
6/625 • Number of events 6
|
0.48%
3/625 • Number of events 3
|
|
Cardiac disorders
Death
|
0.00%
0/625
|
0.64%
4/625 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Periprosthetic fracture
|
0.16%
1/625 • Number of events 1
|
0.00%
0/625
|
|
Musculoskeletal and connective tissue disorders
Dehiscence
|
0.64%
4/625 • Number of events 4
|
0.00%
0/625
|
|
Musculoskeletal and connective tissue disorders
Chronic lateral patellar irritation
|
0.16%
1/625 • Number of events 1
|
0.00%
0/625
|
|
Infections and infestations
Death
|
0.16%
1/625 • Number of events 1
|
0.00%
0/625
|
|
Musculoskeletal and connective tissue disorders
Hemarthrosis
|
0.16%
1/625 • Number of events 1
|
0.00%
0/625
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis
|
2.4%
15/625 • Number of events 15
|
0.64%
4/625 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Below knee amputation
|
0.16%
1/625 • Number of events 1
|
0.00%
0/625
|
|
Musculoskeletal and connective tissue disorders
Total hip replacement
|
0.00%
0/625
|
0.48%
3/625 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Hip dislocation
|
0.00%
0/625
|
0.16%
1/625 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Femoral fracture
|
0.00%
0/625
|
0.16%
1/625 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Death
|
0.00%
0/625
|
0.16%
1/625 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Failed TKA
|
0.00%
0/625
|
0.16%
1/625 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Carpal tunnel syndrome
|
0.00%
0/625
|
0.16%
1/625 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Conralateral TKA
|
0.00%
0/625
|
0.48%
3/625 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Lumbar stenosis
|
0.00%
0/625
|
0.16%
1/625 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Hetrotrophic bone formation
|
0.00%
0/625
|
0.16%
1/625 • Number of events 1
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.00%
0/625
|
0.16%
1/625 • Number of events 1
|
|
Nervous system disorders
Peroneal nerve entrapment
|
0.00%
0/625
|
0.16%
1/625 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Achilles tendon rupture
|
0.00%
0/625
|
0.16%
1/625 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place