Ceramic on Metal Total Hip Replacement System Multi-Center,Investigational Device Exemption Clinical Trial (COM)
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|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
|Condition or disease||Intervention/treatment||Phase|
|Total Hip Replacement System||Device: Ceramic on metal prosthesis||Phase 4|
This investigational device study is a non-randomized, non-inferiority, multi-center, historically controlled study. The primary objective will be evaluated at the primary endpoint (24 months) by the primary efficacy and safety measures that define patient success. The proportion of patient success will determine whether the primary objective has been met (study success).
The investigational device will be compared to a historical control comprised of patients from the TRANSCEND® Ceramic on Ceramic IDE study. This comparison will be made using all primary and secondary measures. However, only primary measures will be used to determine study success.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||253 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ceramic on Metal Total Hip Replacement System IDE: A Non-Randomized, Multi-center, Historically Controlled Safety and Efficacy Study (Protocol Number:06-LJH-002)|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Ceramic on metal prosthesis
Ceramic on metal prosthesis
Device: Ceramic on metal prosthesis
Ceramic femoral head with a metal acetabular component
- Primary Endpoint/Measures: Success at 24 Months [ Time Frame: 24 Month ]
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
- The Secondary Measures of the UCLA Functional Assessments [ Time Frame: 24 months ]
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.
- WOMAC Raw Total Score [ Time Frame: 24 months ]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).
- Metal Ion Analysis (Unilateral Only):Serum Cobalt [ Time Frame: 24 months ]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.
- Metal Ion Analysis; Unilateral Only; Serum Chromium [ Time Frame: 24 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820443
|United States, California|
|St. Vincent's Hospital|
|Los Angeles, California, United States, 90057|