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not move forward with the commercialization of this product based on marketing needs and there is not a known safety issue or concern
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The purpose of this study is to demonstrate non-inferiority of the Ceramic on Metal Total Hip when compared to a TRANSCEND® historical control group of patients with primary total hip replacement.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceramic on metal prosthesis | Experimental | Ceramic on metal prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceramic on metal prosthesis | Device | Ceramic femoral head with a metal acetabular component |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint/Measures: Success at 24 Months | The patient success definition is measured at the 24 month interval by the following:
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 | 24 Month |
| Measure | Description | Time Frame |
|---|---|---|
| The Secondary Measures of the UCLA Functional Assessments | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Previous total hip replacement, hemi-arthroplasty, or fusion on the ipsilateral side,
Patients with a previous Girdlestone procedure,
Patient has a known metal allergy to any component of the investigational device (e.g.cobalt, chromium, titanium or ceramics),
Patient has had a total knee arthroplasty of either leg,
Patient has vascular insufficiency, muscular atrophy, or neuromuscular disease in the affected limb (based on the Investigator's discretion),
Patients with congenital disorder or deformity not adequately addressed by hip replacement or has sufficient anatomic variance or remodeling of the hip joint that may place the patient at risk for mechanical failure or that requires a structural bone graft (based on the Investigator's discretion),
Patients with severe instability or deformity of the ligaments or surrounding soft tissues that would preclude stability of the implant (based on the Investigator's discretion),
Patients with Charcot or neuropathic arthropathy, or neuromuscular disease or any other condition that would interfere with patient self-assessment or pain, the function or quality of life required for patient reported outcomes during the study (based on the Investigator's discretion),
Patient, male or postmenopausal female, with a history of metabolic bone disease, as defined by the following:
Active malignancy,
Patient has an active infection (e.g. hepatitis, AIDS, ARC or is HIV positive)- systemic or at the site of intended surgery,
Clinical diagnosis of renal insufficiency where renal function is abnormal and incapable of sustaining essential bodily functions. (e.g. as reported by KRONOS lab BUN, Creatinine and estimated glomerular filtration rate (GFR <15 mL/min/1.73 m2)
Currently participating in any investigational studies not related to this study's preoperative or postoperative care,
Patient has a mental illness or belongs to a vulnerable population (e.g., is a prisoner or a severe drug abuser, or is developmentally disabled) such that his or her ability to provide informed consent or comply with follow-up requirements is compromised,
Patient is pregnant or interested in becoming pregnant in the next 2 years, (Due to the required x-rays for the study),
Other severe acute or chronic medical condition that may interfere with the interpretation of the study results, in the judgment of the investigator, which would make the patient inappropriate for entry into this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Hospital | Los Angeles | California | 90057 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11904577 | Result | 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. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ceramic on Metal Prosthesis | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Op |
| |||||||||||||
| Op |
| |||||||||||||
| Immediately |
| |||||||||||||
| 3 Month |
| |||||||||||||
| 6 Month |
| |||||||||||||
| 12 Month |
| |||||||||||||
| 24 Month |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ceramic on Metal Prosthesis | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Endpoint/Measures: Success at 24 Months | The patient success definition is measured at the 24 month interval by the following:
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 | 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. | Posted | Number | participants | 24 Month |
The period includes all the time with a date of surgery on or before the date of database closure.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ceramic on Metal Prosthesis | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matt C. Paul, Project Manager | MicroPort Orthepedics | (901) 867-4350 | mpaul@ortho.microport.com |
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| 24 months |
| WOMAC Raw Total Score | 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). | 24 months |
| Metal Ion Analysis (Unilateral Only):Serum Cobalt | 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. | 24 months |
| Metal Ion Analysis; Unilateral Only; Serum Chromium | 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 | 24 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^(2) |
|
| Height | Mean | Standard Deviation | Inches |
|
| Weight | Mean | Standard Deviation | lbs |
|
| Diagnosis | Number | participants |
|
|
|
|
| Secondary | The Secondary Measures of the UCLA Functional Assessments | 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. | Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 177 participants were evaluated at 24 months. | Posted | Mean | Standard Deviation | units on a scale (10 points) | 24 months |
|
|
|
| Secondary | WOMAC Raw Total Score | 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). | Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 175 participants were evaluated at 24 months. | Posted | Mean | Standard Deviation | units on a scale | 24 months |
|
|
|
| Secondary | Metal Ion Analysis (Unilateral Only):Serum Cobalt | 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. | 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. | Posted | Mean | Standard Deviation | ug/L | 24 months |
|
|
|
| Secondary | Metal Ion Analysis; Unilateral Only; Serum Chromium | 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 | 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. | Posted | Mean | Standard Deviation | ug/L | 24 months |
|
|
|
| 22 |
| 253 |
| 85 |
| 253 |
| Atrial Fibrillation | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Osteonecrosis | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Carcinoid tumor of the stomach | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Abscess Neck | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Intermittent Claudication | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Intervertebral disc operation | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
|
| Myocardial infarction | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Ovarian Cancer | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pancreatic carcinoma | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Retroperitoneal Haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Subcutaneous abscess | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Surgical failure | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pain in Hip | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Trochanteric bursitis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Knee Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
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