Trial Outcomes & Findings for Metal on Metal Versus Ceramic on Metal Hip Replacement (NCT NCT00208494)
NCT ID: NCT00208494
Last Updated: 2013-08-14
Results Overview
The composite success/failure of the implant was made up of radiographic, clinical and revision data. Radiographic success was determined by femoral subsidence =/\< 2mm, acetabular migration =/\< 2mm, cup inclination =/\< 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating. Clinical success was determined by a Harris Hip score equal to or greater than 80. A hip (patient) was considered to be a composite success at study endpoint if it was a radiographic and clinical success and no revision of any component had taken place.
COMPLETED
NA
392 participants
At 24 months
2013-08-14
Participant Flow
Eleven sites enrolled 392 subjects who were then randomized into two groups. The investigational group, Ceramic-on-Metal (COM) and the control group, Metal-on-Metal (MOM). Two subjects were intraoperatively excluded, resulting in 194 subjects COM subjects and 196 MOM subjects.
Participant milestones
| Measure |
Ceramic-on-Metal (COM) Total Hip Implant
The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
|
Metal-on-Metal (MOM) Total Hip Implant
The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
|
|---|---|---|
|
Overall Study
STARTED
|
194
|
196
|
|
Overall Study
COMPLETED
|
164
|
162
|
|
Overall Study
NOT COMPLETED
|
30
|
34
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metal on Metal Versus Ceramic on Metal Hip Replacement
Baseline characteristics by cohort
| Measure |
Ceramic-on-Metal (COM) Total Hip Implant
n=194 Participants
The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
|
Metal-on-Metal (MOM) Total Hip Implant
n=196 Participants
The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
|
Total
n=390 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
Age
|
58.9 Years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
59.1 Years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
59 Years
STANDARD_DEVIATION 9.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
194 participants
n=5 Participants
|
196 participants
n=7 Participants
|
390 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 24 monthsPopulation: Out of the 390 subjects, 84 subjects were removed from the analysis for the following reasons: 2 deaths (1 in each arm); 3 protocol violations (2 COM, 1 MOM); 28 bilateral (12 COM, 16 MOM); 39 subjects had no 24-month Harris Hip score (22 COM, 17 MOM); and 12 subjects had no 24-month x-ray (4 COM, 8 MOM).
The composite success/failure of the implant was made up of radiographic, clinical and revision data. Radiographic success was determined by femoral subsidence =/\< 2mm, acetabular migration =/\< 2mm, cup inclination =/\< 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating. Clinical success was determined by a Harris Hip score equal to or greater than 80. A hip (patient) was considered to be a composite success at study endpoint if it was a radiographic and clinical success and no revision of any component had taken place.
Outcome measures
| Measure |
Ceramic-on-Metal (COM) Total Hip Implant
n=154 Participants
The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
|
Metal-on-Metal (MOM) Total Hip Implant
n=152 Participants
The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
|
|---|---|---|
|
Composite Success/Failure
|
142 Participants
|
141 Participants
|
Adverse Events
Ceramic-on-Metal (COM) Total Hip Implant
Metal-on-Metal (MOM) Total Hip Implant
Serious adverse events
| Measure |
Ceramic-on-Metal (COM) Total Hip Implant
n=194 participants at risk
The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
|
Metal-on-Metal (MOM) Total Hip Implant
n=196 participants at risk
The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bone Fracture
|
1.0%
2/194 • Number of events 2
|
0.51%
1/196 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.5%
3/194 • Number of events 3
|
1.0%
2/196 • Number of events 2
|
|
Cardiac disorders
Cardiovascular
|
2.6%
5/194 • Number of events 5
|
2.0%
4/196 • Number of events 4
|
|
Nervous system disorders
Central Nervous System
|
1.5%
3/194 • Number of events 3
|
1.0%
2/196 • Number of events 2
|
|
General disorders
Constitutional Symptom
|
0.00%
0/194
|
0.51%
1/196 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
0.00%
0/194
|
0.51%
1/196 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Dislocation
|
1.0%
2/194 • Number of events 2
|
1.0%
2/196 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal
|
2.6%
5/194 • Number of events 5
|
1.0%
2/196 • Number of events 2
|
|
Renal and urinary disorders
Genitourinary
|
1.5%
3/194 • Number of events 3
|
0.51%
1/196 • Number of events 1
|
|
Blood and lymphatic system disorders
Hematological
|
0.52%
1/194 • Number of events 1
|
1.0%
2/196 • Number of events 2
|
|
Blood and lymphatic system disorders
Hematoma requiring drainage
|
0.52%
1/194 • Number of events 1
|
0.51%
1/196 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
10.8%
21/194 • Number of events 21
|
11.7%
23/196 • Number of events 23
|
|
Surgical and medical procedures
Operative Adverse Event (fracture of femur
|
1.5%
3/194 • Number of events 3
|
4.1%
8/196 • Number of events 8
|
|
Surgical and medical procedures
Operative Adverse Event (other complication
|
0.00%
0/194
|
1.0%
2/196 • Number of events 2
|
|
Surgical and medical procedures
Operative Adverse Event (seating acetabular prosthesis)
|
0.00%
0/194
|
1.0%
2/196 • Number of events 3
|
|
Nervous system disorders
Peripheral nervous system
|
0.00%
0/194
|
0.51%
1/196 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory system
|
1.0%
2/194 • Number of events 2
|
0.51%
1/196 • Number of events 1
|
|
Infections and infestations
Deep Infection
|
0.52%
1/194 • Number of events 1
|
0.00%
0/196
|
Other adverse events
| Measure |
Ceramic-on-Metal (COM) Total Hip Implant
n=194 participants at risk
The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
|
Metal-on-Metal (MOM) Total Hip Implant
n=196 participants at risk
The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Trochanteric Bursitis
|
7.7%
15/194 • Number of events 15
|
5.1%
10/196 • Number of events 10
|
|
Nervous system disorders
Central Nervous System
|
7.2%
14/194 • Number of events 14
|
7.1%
14/196 • Number of events 14
|
|
Renal and urinary disorders
Genitourinary
|
7.7%
15/194 • Number of events 15
|
9.7%
19/196 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory system
|
8.2%
16/194 • Number of events 16
|
9.7%
19/196 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
16.0%
31/194 • Number of events 31
|
12.2%
24/196 • Number of events 24
|
|
Blood and lymphatic system disorders
Hematological
|
7.2%
14/194 • Number of events 14
|
8.7%
17/196 • Number of events 17
|
|
Cardiac disorders
Cardiovascular
|
12.9%
25/194 • Number of events 25
|
10.2%
20/196 • Number of events 20
|
|
Gastrointestinal disorders
Gastrointestinal
|
9.8%
19/194 • Number of events 19
|
9.7%
19/196 • Number of events 19
|
|
General disorders
Constitutional symptom
|
10.8%
21/194 • Number of events 21
|
8.7%
17/196 • Number of events 17
|
|
Injury, poisoning and procedural complications
Wound problem
|
6.2%
12/194 • Number of events 12
|
5.6%
11/196 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
54.6%
106/194 • Number of events 106
|
46.4%
91/196 • Number of events 91
|
Additional Information
Jennifer Hoag, MS, Project Leader, Clinical Research
DePuy Orthopaedics, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60