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Metal on Metal Versus Ceramic on Metal Hip Replacement

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ClinicalTrials.gov Identifier: NCT00208494
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : August 4, 2011
Last Update Posted : August 14, 2013
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Non-inflammatory Joint Diseases
Interventions Device: Total Hip Replacement
Device: Total hip replacement
Enrollment 392
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Ceramic-on-Metal (COM) Total Hip Implant Metal-on-Metal (MOM) Total Hip Implant
Hide Arm/Group Description The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert. The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
Period Title: Overall Study
Started 194 196
Completed 164 162
Not Completed 30 34
Arm/Group Title Ceramic-on-Metal (COM) Total Hip Implant Metal-on-Metal (MOM) Total Hip Implant Total
Hide Arm/Group Description The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert. The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert. Total of all reporting groups
Overall Number of Baseline Participants 194 196 390
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 194 participants 196 participants 390 participants
58.9  (10.1) 59.1  (9.5) 59  (9.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 196 participants 390 participants
Female
83
  42.8%
91
  46.4%
174
  44.6%
Male
111
  57.2%
105
  53.6%
216
  55.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 194 participants 196 participants 390 participants
194 196 390
1.Primary Outcome
Title Composite Success/Failure
Hide Description 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.
Time Frame At 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Ceramic-on-Metal (COM) Total Hip Implant Metal-on-Metal (MOM) Total Hip Implant
Hide Arm/Group Description:
The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
Overall Number of Participants Analyzed 154 152
Measure Type: Number
Unit of Measure: Participants
142 141
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ceramic-on-Metal (COM) Total Hip Implant Metal-on-Metal (MOM) Total Hip Implant
Hide Arm/Group Description The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert. The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
All-Cause Mortality
Ceramic-on-Metal (COM) Total Hip Implant Metal-on-Metal (MOM) Total Hip Implant
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ceramic-on-Metal (COM) Total Hip Implant Metal-on-Metal (MOM) Total Hip Implant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/194 (20.62%)      48/196 (24.49%)    
Blood and lymphatic system disorders     
Hematological  1/194 (0.52%)  1 2/196 (1.02%)  2
Hematoma requiring drainage  1/194 (0.52%)  1 1/196 (0.51%)  1
Cardiac disorders     
Cardiovascular  5/194 (2.58%)  5 4/196 (2.04%)  4
Gastrointestinal disorders     
Gastrointestinal  5/194 (2.58%)  5 2/196 (1.02%)  2
General disorders     
Constitutional Symptom  0/194 (0.00%)  0 1/196 (0.51%)  1
Infections and infestations     
Deep Infection  1/194 (0.52%)  1 0/196 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Bone Fracture  2/194 (1.03%)  2 1/196 (0.51%)  1
Dislocation  2/194 (1.03%)  2 2/196 (1.02%)  2
Musculoskeletal  21/194 (10.82%)  21 23/196 (11.73%)  23
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer  3/194 (1.55%)  3 2/196 (1.02%)  2
Nervous system disorders     
Central Nervous System  3/194 (1.55%)  3 2/196 (1.02%)  2
Peripheral nervous system  0/194 (0.00%)  0 1/196 (0.51%)  1
Renal and urinary disorders     
Genitourinary  3/194 (1.55%)  3 1/196 (0.51%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory system  2/194 (1.03%)  2 1/196 (0.51%)  1
Skin and subcutaneous tissue disorders     
Dermatological  0/194 (0.00%)  0 1/196 (0.51%)  1
Surgical and medical procedures     
Operative Adverse Event (fracture of femur  3/194 (1.55%)  3 8/196 (4.08%)  8
Operative Adverse Event (other complication  0/194 (0.00%)  0 2/196 (1.02%)  2
Operative Adverse Event (seating acetabular prosthesis)  0/194 (0.00%)  0 2/196 (1.02%)  3
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ceramic-on-Metal (COM) Total Hip Implant Metal-on-Metal (MOM) Total Hip Implant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   137/194 (70.62%)      125/196 (63.78%)    
Blood and lymphatic system disorders     
Hematological  14/194 (7.22%)  14 17/196 (8.67%)  17
Cardiac disorders     
Cardiovascular  25/194 (12.89%)  25 20/196 (10.20%)  20
Gastrointestinal disorders     
Gastrointestinal  19/194 (9.79%)  19 19/196 (9.69%)  19
General disorders     
Constitutional symptom  21/194 (10.82%)  21 17/196 (8.67%)  17
Injury, poisoning and procedural complications     
Wound problem  12/194 (6.19%)  12 11/196 (5.61%)  11
Musculoskeletal and connective tissue disorders     
Trochanteric Bursitis  15/194 (7.73%)  15 10/196 (5.10%)  10
Musculoskeletal  106/194 (54.64%)  106 91/196 (46.43%)  91
Nervous system disorders     
Central Nervous System  14/194 (7.22%)  14 14/196 (7.14%)  14
Renal and urinary disorders     
Genitourinary  15/194 (7.73%)  15 19/196 (9.69%)  19
Respiratory, thoracic and mediastinal disorders     
Respiratory system  16/194 (8.25%)  16 19/196 (9.69%)  19
Skin and subcutaneous tissue disorders     
Dermatological  31/194 (15.98%)  31 24/196 (12.24%)  24
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.
Results Point of Contact
Name/Title: Jennifer Hoag, MS, Project Leader, Clinical Research
Organization: DePuy Orthopaedics, Inc.
Phone: 574-372-7399
Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00208494     History of Changes
Other Study ID Numbers: 03062
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: July 11, 2011
Results First Posted: August 4, 2011
Last Update Posted: August 14, 2013