Trial Outcomes & Findings for Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement (NCT NCT00588861)
NCT ID: NCT00588861
Last Updated: 2017-01-27
Results Overview
The Harris Hip Score is detailed below as a range. 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent." 80-89 is considered "Good." 70-79 is considered "Fair." Less than 70 is considered "Poor."
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
400 participants
Primary outcome timeframe
10 Years Post-Operative
Results posted on
2017-01-27
Participant Flow
Patients were recruited by the investigator based on the FDA cleared inclusion/exclusion criteria in the protocol.
The patients were assigned to each group according to the bone cement used with the implant.
Participant milestones
| Measure |
Answer Stem Utilizing Simplex Cement
Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
|
Answer Stem Utilizing Palacos Cement
Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
|
|---|---|---|
|
Pre-Operative
STARTED
|
202
|
200
|
|
Pre-Operative
COMPLETED
|
107
|
114
|
|
Pre-Operative
NOT COMPLETED
|
95
|
86
|
|
6 Months
STARTED
|
107
|
114
|
|
6 Months
COMPLETED
|
9
|
41
|
|
6 Months
NOT COMPLETED
|
98
|
73
|
|
1 Year
STARTED
|
107
|
114
|
|
1 Year
COMPLETED
|
18
|
32
|
|
1 Year
NOT COMPLETED
|
89
|
82
|
|
2 Years
STARTED
|
107
|
114
|
|
2 Years
COMPLETED
|
15
|
27
|
|
2 Years
NOT COMPLETED
|
92
|
87
|
|
4 Years
STARTED
|
107
|
114
|
|
4 Years
COMPLETED
|
16
|
11
|
|
4 Years
NOT COMPLETED
|
91
|
103
|
|
6 Years
STARTED
|
107
|
114
|
|
6 Years
COMPLETED
|
3
|
5
|
|
6 Years
NOT COMPLETED
|
104
|
109
|
|
8 Years
STARTED
|
107
|
114
|
|
8 Years
COMPLETED
|
2
|
0
|
|
8 Years
NOT COMPLETED
|
105
|
114
|
|
10 Years
STARTED
|
107
|
114
|
|
10 Years
COMPLETED
|
0
|
0
|
|
10 Years
NOT COMPLETED
|
107
|
114
|
Reasons for withdrawal
| Measure |
Answer Stem Utilizing Simplex Cement
Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
|
Answer Stem Utilizing Palacos Cement
Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
|
|---|---|---|
|
Pre-Operative
Patients Did Not Complete Preop Data
|
95
|
86
|
|
6 Months
Patients did not return for follow-up
|
98
|
73
|
|
1 Year
Patients did not return for follow-up
|
89
|
82
|
|
2 Years
Patients did not return for follow-up
|
92
|
87
|
|
4 Years
Patients did not return for follow-up
|
91
|
103
|
|
6 Years
Patients did not return for follow-up
|
104
|
109
|
|
8 Years
Patients did not return for follow-up
|
105
|
114
|
|
10 Years
Incomplete due to study termination
|
107
|
114
|
Baseline Characteristics
Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement
Baseline characteristics by cohort
| Measure |
Answer Stem Utilizing Simplex Cement
n=202 Participants
Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
|
Answer Stem Utilizing Palacos Cement
n=200 Participants
Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
|
Total
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73 years
n=5 Participants
|
76 years
n=7 Participants
|
75 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 Years Post-OperativePopulation: This population represents patients that returned for follow-up per protocol. Because no patients returned at the primary outcome measure time frame (10 years), 0 patients were analyzed at 10 years.
The Harris Hip Score is detailed below as a range. 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent." 80-89 is considered "Good." 70-79 is considered "Fair." Less than 70 is considered "Poor."
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 yearPopulation: This population represents patients that returned for follow-up per protocol.
Harris Hip Score Pain is detailed below as mean score for the Harris Hip Score Pain question. 44 being the highest score, and 0 being the lowest score. 44 is considered "None/Ignores." 40 is considered "Slight/Occasional." 30 is considered "Mild." 20 is considered "Moderate." 10 is considered "Marked." 0 is considered "Totally Disabled."
Outcome measures
| Measure |
Answer Stem Utilizing Simplex Cement
n=202 Participants
Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
|
Answer Stem Utilizing Palacos Cement
n=200 Participants
Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
|
|---|---|---|
|
Harris Hip Score Pain
Pre-Operative Harris Hip Score Pain
|
15.89 Mean Hip Pain
Standard Deviation 7.64
|
14.74 Mean Hip Pain
Standard Deviation 7.78
|
|
Harris Hip Score Pain
6 Month Harris Hip Score Pain
|
39.78 Mean Hip Pain
Standard Deviation 4.06
|
36.25 Mean Hip Pain
Standard Deviation 9.69
|
|
Harris Hip Score Pain
1 Year Harris Hip Score Pain
|
37.89 Mean Hip Pain
Standard Deviation 9.54
|
37.76 Mean Hip Pain
Standard Deviation 9.24
|
|
Harris Hip Score Pain
2 Year Harris Hip Score Pain
|
36.93 Mean Hip Pain
Standard Deviation 9.47
|
34.59 Mean Hip Pain
Standard Deviation 10.54
|
|
Harris Hip Score Pain
4 Year Harris Hip Score Pain
|
38.38 Mean Hip Pain
Standard Deviation 9.78
|
41.27 Mean Hip Pain
Standard Deviation 4.22
|
|
Harris Hip Score Pain
6 Year Harris Hip Score Pain
|
44.00 Mean Hip Pain
Standard Deviation 0
|
42.00 Mean Hip Pain
Standard Deviation 2.83
|
|
Harris Hip Score Pain
8 Year Harris Hip Score Pain
|
37.00 Mean Hip Pain
Standard Deviation 9.90
|
NA Mean Hip Pain
Standard Deviation NA
No patients were analyzed at this time interval
|
Adverse Events
Answer Stem Utilizing Simplex Cement
Serious events: 15 serious events
Other events: 0 other events
Deaths: 0 deaths
Answer Stem Utilizing Palacos Cement
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Answer Stem Utilizing Simplex Cement
n=202 participants at risk
Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
|
Answer Stem Utilizing Palacos Cement
n=200 participants at risk
Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Dislocation
|
4.5%
9/202 • Number of events 31 • 8 Years
|
0.50%
1/200 • Number of events 1 • 8 Years
|
|
Musculoskeletal and connective tissue disorders
Femoral loosening
|
0.99%
2/202 • Number of events 2 • 8 Years
|
0.00%
0/200 • 8 Years
|
|
Infections and infestations
Deep infection < 6 weeks
|
0.50%
1/202 • Number of events 1 • 8 Years
|
1.0%
2/200 • Number of events 2 • 8 Years
|
|
Infections and infestations
Deep infection > 6 weeks
|
0.50%
1/202 • Number of events 1 • 8 Years
|
0.50%
1/200 • Number of events 1 • 8 Years
|
|
Cardiac disorders
Myocardial infarction
|
0.50%
1/202 • Number of events 1 • 8 Years
|
0.00%
0/200 • 8 Years
|
|
Vascular disorders
Stroke
|
0.50%
1/202 • Number of events 1 • 8 Years
|
0.00%
0/200 • 8 Years
|
|
Musculoskeletal and connective tissue disorders
Femoral, acetabular loosening and instability
|
0.00%
0/202 • 8 Years
|
0.50%
1/200 • Number of events 1 • 8 Years
|
|
Surgical and medical procedures
Revision with all components removed and re-implantation
|
0.00%
0/202 • 8 Years
|
1.0%
2/200 • Number of events 2 • 8 Years
|
|
Surgical and medical procedures
I&D, exchange of poly liner
|
0.00%
0/202 • 8 Years
|
0.50%
1/200 • Number of events 1 • 8 Years
|
Other adverse events
Adverse event data not reported
Additional Information
Nick Higdon, Clinical Research Specialist
Biomet Manufacturing
Phone: 1-800-348-9500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can conduct a pre-publication review of articles, papers, or presentations which the PI desires to publish. Any such review must be completed by sponsor within thirty (30)days of the submission of the request. The PI must include whatever credits the sponsor deems necessary or appropriate to disclose its proprietary interest to the material disclosed in the article, paper or presentation.
- Publication restrictions are in place
Restriction type: OTHER