ID

18692

Description

Safety and Effectiveness Study of the Reflection Ceramic Acetabular System; ODM derived from: https://clinicaltrials.gov/show/NCT00663351

Link

https://clinicaltrials.gov/show/NCT00663351

Keywords

Versions (1)
  1. 11/16/16 11/16/16 -
Uploaded on

November 16, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00663351

English

Eligibility Osteoarthritis NCT00663351

1 forms  
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
(patient must meet all of the following characteristics to be enrolled in the study):
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
males and females, 21 to 80 years of age, inclusive;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
primary diagnosis of non-inflammatory arthritis (osteoarthritis) or inflammatory arthritis (rheumatoid arthritis), or patients requiring a revision as specified previously;
Description

Osteoarthritis | Arthritis | Rheumatoid Arthritis | Revision Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C0029408
UMLS CUI [2]
C0003864
UMLS CUI [3]
C0003873
UMLS CUI [4,1]
C1527075
UMLS CUI [4,2]
C0686904
the patient or his/her legal guardian is willing to consent to participate in the study by signing and dating the approved consent form;
Description

Informed Consent | Informed Consent Legal Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
the patient will be available for follow-up through at least two years postoperative;
Description

Follow-up Postoperative Patient Available

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0032790
UMLS CUI [1,3]
C0030705
UMLS CUI [1,4]
C0470187
the patient has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk (fda requirement);
Description

Medical Clearance Preoperative Acceptable | Cardiac function | Pulmonary function | Hematologic function | Condition Operative risk Excessive Free of

Data type

boolean

Alias
UMLS CUI [1,1]
C4042833
UMLS CUI [1,2]
C0445204
UMLS CUI [1,3]
C1879533
UMLS CUI [2]
C0232164
UMLS CUI [3]
C0231921
UMLS CUI [4]
C0221130
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0747003
UMLS CUI [5,3]
C0442802
UMLS CUI [5,4]
C0332296
the patient has a total harris hip score of less than or equal to 60 (fda requirement);
Description

Harris hip score

Data type

boolean

Alias
UMLS CUI [1]
C2919875
the patient meets none of the exclusion criteria.
Description

Exclusion Criteria None Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0549184
UMLS CUI [1,3]
C1550543
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
(patient with any of the following characteristics must be excluded from the study):
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
patients known to have insufficient quantity or quality of bone support resulting from conditions such as cancer, femoral osteotomy, girdlestone resection, significant osteoporosis or metabolic disorders of calcified tissues. patients with physical conditions tending to place extreme loads on implants such as morbid obesity (> 100 pounds over desirable body weight), charcot joints, muscle deficiencies, or multiple joint disabilities;
Description

Bone Support Quantity Insufficient | Bone Support Quality Insufficient | Malignant Neoplasms | Osteotomy Femoral | Excision arthroplasty of the hip | Osteoporosis Significant | Metabolic Diseases Tissue Calcified | Obesity, Morbid | Neurogenic arthropathy | Myopathy | Polyarthropathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C1521721
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0231180
UMLS CUI [2,1]
C0262950
UMLS CUI [2,2]
C1521721
UMLS CUI [2,3]
C0332306
UMLS CUI [2,4]
C0231180
UMLS CUI [3]
C0006826
UMLS CUI [4,1]
C0029468
UMLS CUI [4,2]
C0015811
UMLS CUI [5]
C0408397
UMLS CUI [6,1]
C0029456
UMLS CUI [6,2]
C0750502
UMLS CUI [7,1]
C0025517
UMLS CUI [7,2]
C0040300
UMLS CUI [7,3]
C0175895
UMLS CUI [8]
C0028756
UMLS CUI [9]
C0003892
UMLS CUI [10]
C0026848
UMLS CUI [11]
C0702154
patients with active localized or systemic infection;
Description

Focal Infection | Sepsis

Data type

boolean

Alias
UMLS CUI [1]
C0016397
UMLS CUI [2]
C0243026
patients who have not reached full skeletal maturity;
Description

Skeletal maturity Full Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C3825673
UMLS CUI [1,2]
C0443225
UMLS CUI [1,3]
C0332268
patient psychological or neurological conditions which tend to preempt the patient's ability or willingness to restrict activities or follow medical advice, especially during the postoperative period, e.g.: drug or alcohol abuse, serious mental illness or retardation, or general neurological conditions;
Description

Mental condition Compliance behavior Limited Postoperative Period | nervous system disorder Compliance behavior Limited Postoperative Period | Substance Use Disorders | Mental disorder Serious | Mental Retardation Serious | Condition Neurologic General

Data type

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0032790
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C0439801
UMLS CUI [2,4]
C0032790
UMLS CUI [3]
C0038586
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0205404
UMLS CUI [5,1]
C0025362
UMLS CUI [5,2]
C0205404
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C0205494
UMLS CUI [6,3]
C0205246
the patient is participating in any other pharmaceutical, biologic or medical device clinical investigation;
Description

Study Subject Participation Status | Investigational New Drugs | Clinical Research biological | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C0008972
UMLS CUI [3,2]
C0205460
UMLS CUI [4]
C2346570
immunosuppressive disorders - immunosuppressive disorders are chronic conditions characterized by markedly inhibited ability to respond to antigenic stimuli. examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), patients receiving therapy to prevent homograft rejection, patients who have acquired immunodeficiency syndrome (aids), or auto-immune diseases (except rheumatoid arthritis).
Description

Immunosuppression | Therapeutic immunosuppression | Adrenal Cortex Hormones | Cytotoxic agent | Antilymphocytic serum | Therapeutic radiology procedure High dose | Therapeutic procedure Preventing Homograft reaction | Acquired Immunodeficiency Syndrome | Autoimmune Diseases | Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0021079
UMLS CUI [3]
C0001617
UMLS CUI [4]
C0304497
UMLS CUI [5]
C3826731
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C0444956
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C1292733
UMLS CUI [7,3]
C1268810
UMLS CUI [8]
C0001175
UMLS CUI [9]
C0004364
UMLS CUI [10]
C0003873
pregnancy.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
patients with known sensitivity to materials in the device.
Description

Hypersensitivity Device material

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3873103
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Similar models

Eligibility Osteoarthritis NCT00663351

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Client Characteristics
Item
(patient must meet all of the following characteristics to be enrolled in the study):
boolean
C0815172 (UMLS CUI [1])
Age
Item
males and females, 21 to 80 years of age, inclusive;
boolean
C0001779 (UMLS CUI [1])
Osteoarthritis | Arthritis | Rheumatoid Arthritis | Revision Patient need for
Item
primary diagnosis of non-inflammatory arthritis (osteoarthritis) or inflammatory arthritis (rheumatoid arthritis), or patients requiring a revision as specified previously;
boolean
C0029408 (UMLS CUI [1])
C0003864 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
C1527075 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
Informed Consent | Informed Consent Legal Guardian
Item
the patient or his/her legal guardian is willing to consent to participate in the study by signing and dating the approved consent form;
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Follow-up Postoperative Patient Available
Item
the patient will be available for follow-up through at least two years postoperative;
boolean
C3274571 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0470187 (UMLS CUI [1,4])
Medical Clearance Preoperative Acceptable | Cardiac function | Pulmonary function | Hematologic function | Condition Operative risk Excessive Free of
Item
the patient has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk (fda requirement);
boolean
C4042833 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
C0232164 (UMLS CUI [2])
C0231921 (UMLS CUI [3])
C0221130 (UMLS CUI [4])
C0348080 (UMLS CUI [5,1])
C0747003 (UMLS CUI [5,2])
C0442802 (UMLS CUI [5,3])
C0332296 (UMLS CUI [5,4])
Harris hip score
Item
the patient has a total harris hip score of less than or equal to 60 (fda requirement);
boolean
C2919875 (UMLS CUI [1])
Exclusion Criteria None Fulfill
Item
the patient meets none of the exclusion criteria.
boolean
C0680251 (UMLS CUI [1,1])
C0549184 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Client Characteristics
Item
(patient with any of the following characteristics must be excluded from the study):
boolean
C0815172 (UMLS CUI [1])
Bone Support Quantity Insufficient | Bone Support Quality Insufficient | Malignant Neoplasms | Osteotomy Femoral | Excision arthroplasty of the hip | Osteoporosis Significant | Metabolic Diseases Tissue Calcified | Obesity, Morbid | Neurogenic arthropathy | Myopathy | Polyarthropathy
Item
patients known to have insufficient quantity or quality of bone support resulting from conditions such as cancer, femoral osteotomy, girdlestone resection, significant osteoporosis or metabolic disorders of calcified tissues. patients with physical conditions tending to place extreme loads on implants such as morbid obesity (> 100 pounds over desirable body weight), charcot joints, muscle deficiencies, or multiple joint disabilities;
boolean
C0262950 (UMLS CUI [1,1])
C1521721 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0231180 (UMLS CUI [1,4])
C0262950 (UMLS CUI [2,1])
C1521721 (UMLS CUI [2,2])
C0332306 (UMLS CUI [2,3])
C0231180 (UMLS CUI [2,4])
C0006826 (UMLS CUI [3])
C0029468 (UMLS CUI [4,1])
C0015811 (UMLS CUI [4,2])
C0408397 (UMLS CUI [5])
C0029456 (UMLS CUI [6,1])
C0750502 (UMLS CUI [6,2])
C0025517 (UMLS CUI [7,1])
C0040300 (UMLS CUI [7,2])
C0175895 (UMLS CUI [7,3])
C0028756 (UMLS CUI [8])
C0003892 (UMLS CUI [9])
C0026848 (UMLS CUI [10])
C0702154 (UMLS CUI [11])
Focal Infection | Sepsis
Item
patients with active localized or systemic infection;
boolean
C0016397 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
Skeletal maturity Full Lacking
Item
patients who have not reached full skeletal maturity;
boolean
C3825673 (UMLS CUI [1,1])
C0443225 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Mental condition Compliance behavior Limited Postoperative Period | nervous system disorder Compliance behavior Limited Postoperative Period | Substance Use Disorders | Mental disorder Serious | Mental Retardation Serious | Condition Neurologic General
Item
patient psychological or neurological conditions which tend to preempt the patient's ability or willingness to restrict activities or follow medical advice, especially during the postoperative period, e.g.: drug or alcohol abuse, serious mental illness or retardation, or general neurological conditions;
boolean
C3840291 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0032790 (UMLS CUI [1,4])
C0027765 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0032790 (UMLS CUI [2,4])
C0038586 (UMLS CUI [3])
C0004936 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0025362 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0348080 (UMLS CUI [6,1])
C0205494 (UMLS CUI [6,2])
C0205246 (UMLS CUI [6,3])
Study Subject Participation Status | Investigational New Drugs | Clinical Research biological | Investigational Medical Device
Item
the patient is participating in any other pharmaceutical, biologic or medical device clinical investigation;
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0008972 (UMLS CUI [3,1])
C0205460 (UMLS CUI [3,2])
C2346570 (UMLS CUI [4])
Immunosuppression | Therapeutic immunosuppression | Adrenal Cortex Hormones | Cytotoxic agent | Antilymphocytic serum | Therapeutic radiology procedure High dose | Therapeutic procedure Preventing Homograft reaction | Acquired Immunodeficiency Syndrome | Autoimmune Diseases | Rheumatoid Arthritis
Item
immunosuppressive disorders - immunosuppressive disorders are chronic conditions characterized by markedly inhibited ability to respond to antigenic stimuli. examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), patients receiving therapy to prevent homograft rejection, patients who have acquired immunodeficiency syndrome (aids), or auto-immune diseases (except rheumatoid arthritis).
boolean
C4048329 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
C0304497 (UMLS CUI [4])
C3826731 (UMLS CUI [5])
C1522449 (UMLS CUI [6,1])
C0444956 (UMLS CUI [6,2])
C0087111 (UMLS CUI [7,1])
C1292733 (UMLS CUI [7,2])
C1268810 (UMLS CUI [7,3])
C0001175 (UMLS CUI [8])
C0004364 (UMLS CUI [9])
C0003873 (UMLS CUI [10])
Pregnancy
Item
pregnancy.
boolean
C0032961 (UMLS CUI [1])
Hypersensitivity Device material
Item
patients with known sensitivity to materials in the device.
boolean
C0020517 (UMLS CUI [1,1])
C3873103 (UMLS CUI [1,2])
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