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Ceramic on Metal Total Hip Replacement System Multi-Center,Investigational Device Exemption Clinical Trial (COM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00820443
Recruitment Status : Terminated (not move forward with the commercialization of this product based on marketing needs and there is not a known safety issue or concern)
First Posted : January 12, 2009
Results First Posted : September 30, 2015
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
MicroPort Orthopedics Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Total Hip Replacement System
Intervention Device: Ceramic on metal prosthesis
Enrollment 253
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ceramic on Metal Prosthesis
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Ceramic on metal prosthesis

Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component

Period Title: Pre-Op
Started 253
Completed 253
Not Completed 0
Period Title: Op
Started 253
Completed 253
Not Completed 0
Period Title: Immediately
Started 253
Completed 248
Not Completed 5
Period Title: 3 Month
Started 253
Completed 244
Not Completed 9
Period Title: 6 Month
Started 253
Completed 233
Not Completed 20
Period Title: 12 Month
Started 250
Completed 226
Not Completed 24
Period Title: 24 Month
Started 245
Completed 202
Not Completed 43
Arm/Group Title Ceramic on Metal Prosthesis
Hide Arm/Group Description

Ceramic on metal prosthesis

Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component

Overall Number of Baseline Participants 253
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 253 participants
Female 60.8  (12.9)
Male 60.3  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 253 participants
Female
128
  50.6%
Male
125
  49.4%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^(2)
Number Analyzed 253 participants
Female 28.2  (5.2)
Male 29.1  (4.6)
Height  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 253 participants
Female 64.2  (2.4)
Male 70.4  (3.0)
Weight  
Mean (Standard Deviation)
Unit of measure:  Lbs
Number Analyzed 253 participants
Female 164.7  (31.1)
Male 205.4  (37.3)
Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 253 participants
Osteo/degenerative arthritis 216
Post-traumatic Arthritis 4
Avascular necrosis 25
Rheumatoid Arthritis 3
Congenital Hip Dysplasia 5
1.Primary Outcome
Title Primary Endpoint/Measures: Success at 24 Months
Hide Description

The patient success definition is measured at the 24 month interval by the following:

  • Harris Hip Score (HHS) of > 80 • < 2mm radiolucency (width) in any Gruen (stem) or DeLee/Charnley (cup) zone and no more than mild pain.
  • No revision or removal of any part of the device for aseptic reasons prior to or on day 730 following the index surgical procedure.

A patient must meet all three criteria in the definition to be considered a success. A patient who does not meet all three criteria will be deemed a failure.

The Harris hip score, is used to measure the outcome of total hip arthroplasty. Eight sections on the HIP are rated by the patient: pain, distance walked, activities, public transportation, support, limp, stairs and sitting. Total scores are out of 100 and grouped as follows: 90 - 100 Excellent,80 - 90 Good,70 - 79 Fair,60 - 69 Poor.< 60 Failed.Any score above 60 is acceptable, although the higher the score, the better the patient's overall adjustment after the surgery

Time Frame 24 Month
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with Harris Hip Score (HHS) of > 80 Because there isn't complete radiographic data,the composite primary outcome is not analyzed at 24 month as in protocol. Only the number of patients who has HHS score greater that 80 is entered.Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 197.
Arm/Group Title Ceramic on Metal Prosthesis
Hide Arm/Group Description:

Ceramic on metal prosthesis

Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component

Overall Number of Participants Analyzed 197
Measure Type: Number
Unit of Measure: participants
163
2.Secondary Outcome
Title The Secondary Measures of the UCLA Functional Assessments
Hide Description

UCLA: University of California LosAngeles Activity Score

UCLA score is a validated scoring system for hip replacement outcome, The single item UCLA scale asks patients to rate their activity level from 1 to 10, with 1 defined as “no physical activity” and 10 defined as “regular participation in impact sports”. The score is the higher the better.

Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 177 participants were evaluated at 24 months.
Arm/Group Title Ceramic on Metal Prosthesis
Hide Arm/Group Description:

Ceramic on metal prosthesis

Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component

Overall Number of Participants Analyzed 177
Mean (Standard Deviation)
Unit of Measure: units on a scale (10 points)
6.8  (1.7)
3.Secondary Outcome
Title WOMAC Raw Total Score
Hide Description The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations (range is 0-96).
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 175 participants were evaluated at 24 months.
Arm/Group Title Ceramic on Metal Prosthesis
Hide Arm/Group Description:

Ceramic on metal prosthesis

Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component

Overall Number of Participants Analyzed 175
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.3  (11.1)
4.Secondary Outcome
Title Metal Ion Analysis (Unilateral Only):Serum Cobalt
Hide Description Serum cobalt and chromium are recommended as the optimal tests for evaluation of joint implant wear, patients with CoM implants have elevated serum chromium and cobalt concentrations. Clinically important implant wear is indicated when serum chromium exceeds 15 ng/mL and cobalt exceeds 10 ng/mL; these symptomatic patients are likely to have significant implant deterioration. serum cobalt and chromium are highest in the first year after implant. In subsequent years, and after run-in wear (initial wear of a hip implant that produces the greatest amount of metal ion release), cobalt and chromium concentrations decline, then reach steady state around 3 years after implant.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only Unilateral participants were collected the Metal Ion data, and due to missing values/assessments/data, not all of the unilateral participants had Metal Ion data at 24 months, only 44 of them were evaluated.
Arm/Group Title Ceramic on Metal Prosthesis
Hide Arm/Group Description:

Ceramic on metal prosthesis

Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component

Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: ug/L
1.06  (0.12)
5.Secondary Outcome
Title Metal Ion Analysis; Unilateral Only; Serum Chromium
Hide Description Serum cobalt and chromium are recommended as the optimal tests for evaluation of joint implant wear, patients with CoM implants have elevated serum chromium and cobalt concentrations. Clinically important implant wear is indicated when serum chromium exceeds 15 ng/mL and cobalt exceeds 10 ng/mL; these symptomatic patients are likely to have significant implant deterioration. serum cobalt and chromium are highest in the first year after implant. In subsequent years, and after run-in wear (initial wear of a hip implant that produces the greatest amount of metal ion release), cobalt and chromium concentrations decline, then reach steady state around 3 years after implant
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only Unilateral participants were collected the Metal Ion data, and due to missing values/assessments/data, not all of the unilateral participants had Metal Ion data at 24 months, only 44 of them were evaluated.
Arm/Group Title Ceramic on Metal Prosthesis
Hide Arm/Group Description:

Ceramic on metal prosthesis

Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component

Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: ug/L
0.79  (0.12)
Time Frame The period includes all the time with a date of surgery on or before the date of database closure.
Adverse Event Reporting Description The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only >=5% frequency are reported.
 
Arm/Group Title Ceramic on Metal Prosthesis
Hide Arm/Group Description

Ceramic on metal prosthesis

Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component

All-Cause Mortality
Ceramic on Metal Prosthesis
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ceramic on Metal Prosthesis
Affected / at Risk (%)
Total   22/253 (8.70%) 
Blood and lymphatic system disorders   
Anemia  1  1/253 (0.40%) 
Cardiac disorders   
Atrial Fibrillation  1  1/253 (0.40%) 
Cardiac arrest  1  1/253 (0.40%) 
Gastrointestinal disorders   
Pancreatic carcinoma  1  1/253 (0.40%) 
Retroperitoneal Haemorrhage  1  1/253 (0.40%) 
General disorders   
Surgical failure  1  1/253 (0.40%) 
Chest Pain  1  1/253 (0.40%) 
Infections and infestations   
Cellulitis  1  1/253 (0.40%) 
Abscess Neck  1  1/253 (0.40%) 
Pneumonia  1  1/253 (0.40%) 
Wound infection  1  1/253 (0.40%) 
Musculoskeletal and connective tissue disorders   
Osteoarthritis  1  1/253 (0.40%) 
Bursitis  1  1/253 (0.40%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Carcinoid tumor of the stomach  1  1/253 (0.40%) 
Nervous system disorders   
Seizure  1  1/253 (0.40%) 
Reproductive system and breast disorders   
Ovarian Cancer  1  1/253 (0.40%) 
Skin and subcutaneous tissue disorders   
Subcutaneous abscess  1  1/253 (0.40%) 
Surgical and medical procedures   
Intervertebral disc operation  1  1/253 (0.40%) 
Hip arthroplasty  1  1/253 (0.40%) 
Vascular disorders   
Osteonecrosis  1  1/253 (0.40%) 
Intermittent Claudication  1  1/253 (0.40%) 
Myocardial infarction  1  1/253 (0.40%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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 Prosthesis
Affected / at Risk (%)
Total   85/253 (33.60%) 
Blood and lymphatic system disorders   
Anemia  1  27/253 (10.67%) 
Musculoskeletal and connective tissue disorders   
Pain in Hip  1  22/253 (8.70%) 
Trochanteric bursitis * 1  21/253 (8.30%) 
Knee Pain * 1  15/253 (5.93%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
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
Layout table for Results Point of Contact information
Name/Title: Matt C. Paul, Project Manager
Organization: MicroPort Orthepedics
Phone: (901) 867-4350
EMail: mpaul@ortho.microport.com
Layout table for additonal information
Responsible Party: MicroPort Orthopedics Inc.
ClinicalTrials.gov Identifier: NCT00820443     History of Changes
Other Study ID Numbers: 06LJH002
First Submitted: January 8, 2009
First Posted: January 12, 2009
Results First Submitted: May 7, 2015
Results First Posted: September 30, 2015
Last Update Posted: September 30, 2015