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

• ClinicalTrials.gov Identifier: NCT00820443
• Recruitment Status: Terminated
• First Posted: January 12, 2009
• Results First Posted: September 30, 2015
• Last Update Posted: September 30, 2015
• Sponsor: MicroPort Orthopedics Inc.
• Information provided by (Responsible Party): MicroPort Orthopedics Inc.

• Study Type: Interventional
• Study Design: Allocation: N/A; 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Ceramic on Metal Prosthesis
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
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

Baseline Characteristics

Arm/Group Title		Ceramic on Metal Prosthesis
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
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

Outcome Measures

1. Primary Outcome

Title	Primary Endpoint/Measures: Success at 24 Months
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

Adverse Events

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
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	--/--
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
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

Limitations and Caveats

[Not Specified]

More Information

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: Matt C. Paul, Project Manager
• Organization: MicroPort Orthepedics
• Phone: (901) 867-4350
• EMail: mpaul@ortho.microport.com

Publications of Results:

National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266.

• Responsible Party: MicroPort Orthopedics Inc.
• ClinicalTrials.gov Identifier: NCT00820443
• 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