ID

22236

Descrição

A Comparison of an Advanced Metal Hip System to a Resurfacing Hip System; ODM derived from: https://clinicaltrials.gov/show/NCT00380549

Link

https://clinicaltrials.gov/show/NCT00380549

Palavras-chave

Versões (1)
  1. 24/05/2017 24/05/2017 -
Transferido a

24 de maio de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00380549

Inglês

Eligibility Osteoarthritis NCT00380549

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
(1) individuals undergoing unilateral total hip replacement with the conserve®
Descrição

Total Hip Replacement Unilateral

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040508
UMLS CUI [1,2]
C0205092
acetabular component and the conserve® a-class bfhä femoral head in combination with an uncemented femoral stem produced from the ti-6a1-4v alloy (astm f-136) with or without titanium plasma coating.
Descrição

Acetabular Hip Joint Prostheses | Femoral Head Prosthesis | Femoral stem prosthesis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0182473
UMLS CUI [2]
C0015803
UMLS CUI [3]
C1304657
(2) patients who are undergoing primary hip surgery for noninflammatory degenerative joint disease (nidjd). composite diagnoses of nidjd include osteo/degenerative arthritis, traumatic arthritis, congenital hip dysplasia, and avascular necrosis.
Descrição

Hip surgery Primary Osteoarthritis of hip | Degenerative polyarthritis | Traumatic arthropathy | Hip Dislocation, Congenital | Avascular necrosis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0596706
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0029410
UMLS CUI [2]
C0029408
UMLS CUI [3]
C0152086
UMLS CUI [4]
C0019555
UMLS CUI [5]
C3887513
(3) patients 18 years of age or older (skeletally mature). (4) patients for whom there is a reasonable expectation that they will be available for each examination scheduled over a two year post-operative follow-up period and for annual exams until the last patient entered into the study has achieved two years of follow-up.
Descrição

Age | Skeletal maturity | Protocol Compliance | Clinical Study Follow-up Postoperative Period | annual; examination

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C3825673
UMLS CUI [3]
C0525058
UMLS CUI [4,1]
C3274571
UMLS CUI [4,2]
C0032790
UMLS CUI [5]
C1401325
(5) patients who agree to participate and sign the informed consent form. (6) patients who do not meet any of the exclusion criteria.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
(1) patients with previous fusions, acute femoral neck fractures, above knee amputations, or significant arthritic changes to the knees.
Descrição

Fusion procedure | Femoral Neck Fractures | Amputation above Knee | arthritic change Knee

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1293131
UMLS CUI [2]
C0015806
UMLS CUI [3,1]
C0002688
UMLS CUI [3,2]
C1282910
UMLS CUI [3,3]
C0022742
UMLS CUI [4,1]
C0741221
UMLS CUI [4,2]
C0022742
(2) patients with evidence of active infection. (3) patients with neurologic or musculoskeletal disease that may adversely affect gait or weight-bearing.
Descrição

Communicable Disease | Nervous system disorder Affecting Gait | Musculoskeletal Disease Affecting Gait | Nervous system disorder Affecting Weight Bearing | Musculoskeletal Disease Affecting Weight Bearing

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0016928
UMLS CUI [3,1]
C0026857
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0016928
UMLS CUI [4,1]
C0027765
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0085086
UMLS CUI [5,1]
C0026857
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0085086
(4) patients who have previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device.
Descrição

Resurfacing Hemi Ipsilateral | Resurfacing Total | HIP ARTHROPLASTY BIPOLAR | HIP ARTHROPLASTY UNIPOLAR | Total hip replacement prosthesis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0444754
UMLS CUI [1,2]
C1285521
UMLS CUI [1,3]
C0441989
UMLS CUI [2,1]
C0444754
UMLS CUI [2,2]
C0439810
UMLS CUI [3]
C0744913
UMLS CUI [4]
C0744916
UMLS CUI [5]
C0302751
(5) patients with neuropathic joints. (6) patients with severe documented psychiatric disease. (7) patients requiring structural bone grafts. (8) patients with a documented allergy to cobalt chromium molybdenum. (9) patients with an ipsilateral girdlestone. (10) patients with sickle cell disease. (11) patients with renal failure as defined by serum creatinine level greater than 180 fmol/l.
Descrição

Neuropathic joints | Mental disorder Severe | Bone Transplantation Patient need for | Hypersensitivity Cobalt-Chromium-Molybdenum Alloy | Excision arthroplasty of the hip Ipsilateral | Anemia, Sickle Cell | Kidney Failure | Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149739
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0005976
UMLS CUI [3,2]
C0686904
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0205998
UMLS CUI [5,1]
C0408397
UMLS CUI [5,2]
C0441989
UMLS CUI [6]
C0002895
UMLS CUI [7]
C0035078
UMLS CUI [8]
C0201976
(12) patients who otherwise meet the study criteria, but refuse to consent in writing to participate in the study.
Descrição

Informed Consent Refused

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
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Similar models

Eligibility Osteoarthritis NCT00380549

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Total Hip Replacement Unilateral
Item
(1) individuals undergoing unilateral total hip replacement with the conserve®
boolean
C0040508 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
Acetabular Hip Joint Prostheses | Femoral Head Prosthesis | Femoral stem prosthesis
Item
acetabular component and the conserve® a-class bfhä femoral head in combination with an uncemented femoral stem produced from the ti-6a1-4v alloy (astm f-136) with or without titanium plasma coating.
boolean
C0182473 (UMLS CUI [1])
C0015803 (UMLS CUI [2])
C1304657 (UMLS CUI [3])
Hip surgery Primary Osteoarthritis of hip | Degenerative polyarthritis | Traumatic arthropathy | Hip Dislocation, Congenital | Avascular necrosis
Item
(2) patients who are undergoing primary hip surgery for noninflammatory degenerative joint disease (nidjd). composite diagnoses of nidjd include osteo/degenerative arthritis, traumatic arthritis, congenital hip dysplasia, and avascular necrosis.
boolean
C0596706 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0029410 (UMLS CUI [1,3])
C0029408 (UMLS CUI [2])
C0152086 (UMLS CUI [3])
C0019555 (UMLS CUI [4])
C3887513 (UMLS CUI [5])
Age | Skeletal maturity | Protocol Compliance | Clinical Study Follow-up Postoperative Period | annual; examination
Item
(3) patients 18 years of age or older (skeletally mature). (4) patients for whom there is a reasonable expectation that they will be available for each examination scheduled over a two year post-operative follow-up period and for annual exams until the last patient entered into the study has achieved two years of follow-up.
boolean
C0001779 (UMLS CUI [1])
C3825673 (UMLS CUI [2])
C0525058 (UMLS CUI [3])
C3274571 (UMLS CUI [4,1])
C0032790 (UMLS CUI [4,2])
C1401325 (UMLS CUI [5])
Informed Consent
Item
(5) patients who agree to participate and sign the informed consent form. (6) patients who do not meet any of the exclusion criteria.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Fusion procedure | Femoral Neck Fractures | Amputation above Knee | arthritic change Knee
Item
(1) patients with previous fusions, acute femoral neck fractures, above knee amputations, or significant arthritic changes to the knees.
boolean
C1293131 (UMLS CUI [1])
C0015806 (UMLS CUI [2])
C0002688 (UMLS CUI [3,1])
C1282910 (UMLS CUI [3,2])
C0022742 (UMLS CUI [3,3])
C0741221 (UMLS CUI [4,1])
C0022742 (UMLS CUI [4,2])
Communicable Disease | Nervous system disorder Affecting Gait | Musculoskeletal Disease Affecting Gait | Nervous system disorder Affecting Weight Bearing | Musculoskeletal Disease Affecting Weight Bearing
Item
(2) patients with evidence of active infection. (3) patients with neurologic or musculoskeletal disease that may adversely affect gait or weight-bearing.
boolean
C0009450 (UMLS CUI [1])
C0027765 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0016928 (UMLS CUI [2,3])
C0026857 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0016928 (UMLS CUI [3,3])
C0027765 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0085086 (UMLS CUI [4,3])
C0026857 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0085086 (UMLS CUI [5,3])
Resurfacing Hemi Ipsilateral | Resurfacing Total | HIP ARTHROPLASTY BIPOLAR | HIP ARTHROPLASTY UNIPOLAR | Total hip replacement prosthesis
Item
(4) patients who have previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device.
boolean
C0444754 (UMLS CUI [1,1])
C1285521 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
C0444754 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
C0744913 (UMLS CUI [3])
C0744916 (UMLS CUI [4])
C0302751 (UMLS CUI [5])
Neuropathic joints | Mental disorder Severe | Bone Transplantation Patient need for | Hypersensitivity Cobalt-Chromium-Molybdenum Alloy | Excision arthroplasty of the hip Ipsilateral | Anemia, Sickle Cell | Kidney Failure | Creatinine measurement, serum
Item
(5) patients with neuropathic joints. (6) patients with severe documented psychiatric disease. (7) patients requiring structural bone grafts. (8) patients with a documented allergy to cobalt chromium molybdenum. (9) patients with an ipsilateral girdlestone. (10) patients with sickle cell disease. (11) patients with renal failure as defined by serum creatinine level greater than 180 fmol/l.
boolean
C0149739 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0005976 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0205998 (UMLS CUI [4,2])
C0408397 (UMLS CUI [5,1])
C0441989 (UMLS CUI [5,2])
C0002895 (UMLS CUI [6])
C0035078 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
Informed Consent Refused
Item
(12) patients who otherwise meet the study criteria, but refuse to consent in writing to participate in the study.
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
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