ID

31277

Description

Global® AP™ Total Shoulder Arthroplasty; ODM derived from: https://clinicaltrials.gov/show/NCT00719771

Lien

https://clinicaltrials.gov/show/NCT00719771

Mots-clés

Versions (1)
  1. 06/08/2018 06/08/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

6 août 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00719771

Anglais

Eligibility Osteoarthritis NCT00719771

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients selected for inclusion will present for primary shoulder arthroplasty with a diagnosis of osteoarthritis and will consent to participate.
Description

Arthroplasty of the shoulder Primary | Osteoarthritis | Informed Consent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0186662
UMLS CUI [1,2]
C0205225
UMLS CUI [2]
C0029408
UMLS CUI [3]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
are under 18 years of age or over 70
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of avn, inflammatory arthritis, fracture or malunion.
Description

Avascular necrosis | Arthritis | Fracture | Malunion

Type de données

boolean

Alias
UMLS CUI [1]
C3887513
UMLS CUI [2]
C0003864
UMLS CUI [3]
C0016658
UMLS CUI [4]
C3898471
have a hemi-arthroplasty
Description

Hemiarthroplasty

Type de données

boolean

Alias
UMLS CUI [1]
C0744743
have destruction of the proximal humerus that precludes rigid fixation of the humeral component
Description

Destruction Proximal humerus | Humeral component fixation Excluded

Type de données

boolean

Alias
UMLS CUI [1,1]
C0238790
UMLS CUI [1,2]
C0588209
UMLS CUI [2,1]
C0449344
UMLS CUI [2,2]
C0332196
have arthritis with insufficient cuff tissue
Description

Arthritis | Rotator Cuff tissue Insufficient

Type de données

boolean

Alias
UMLS CUI [1]
C0003864
UMLS CUI [2,1]
C0085515
UMLS CUI [2,2]
C0040300
UMLS CUI [2,3]
C0205412
have had a failed rotator cuff surgery
Description

Rotator Cuff Operative Surgical Procedures failed

Type de données

boolean

Alias
UMLS CUI [1,1]
C0085515
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0231175
have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified
Description

Loss Musculature Limb Affected | Neuromuscular impairment Limb Affected | Vascular deficiency Limb Affected | Procedure Impaired

Type de données

boolean

Alias
UMLS CUI [1,1]
C1517945
UMLS CUI [1,2]
C1995013
UMLS CUI [1,3]
C0015385
UMLS CUI [1,4]
C0392760
UMLS CUI [2,1]
C4062805
UMLS CUI [2,2]
C0015385
UMLS CUI [2,3]
C0392760
UMLS CUI [3,1]
C1394931
UMLS CUI [3,2]
C0015385
UMLS CUI [3,3]
C0392760
UMLS CUI [4,1]
C0184661
UMLS CUI [4,2]
C0221099
have evidence of active infection
Description

Communicable Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0009450
present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint) - have a known active metastatic or neoplastic disease
Description

Neuromuscular impairment Shoulder | Neuropathic joints | Injury of brachial plexus Associated with Flail shoulder joint | Neoplasm Metastasis | Neoplastic disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C4062805
UMLS CUI [1,2]
C0037004
UMLS CUI [2]
C0149739
UMLS CUI [3,1]
C0161446
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C2894970
UMLS CUI [4]
C0027627
UMLS CUI [5]
C1882062
are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow-up visits prescribed by the protocol
Description

Compliance behavior Rehabilitation therapy Unwilling | Compliance behavior Rehabilitation therapy Unable | Postoperative follow-up visit failed

Type de données

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0034991
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0034991
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C2585426
UMLS CUI [3,2]
C0231175
are skeletally immature.
Description

Skeletal Immature

Type de données

boolean

Alias
UMLS CUI [1,1]
C0521324
UMLS CUI [1,2]
C0205252
have a known allergic reaction to implant metals, polyethylene or a tissue reaction to corrosion or wear products
Description

Allergic Reaction Metallic implant | Allergic Reaction Polyethylenes | Tissue Reaction Corrosion | Tissue Reaction Clothes

Type de données

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C3693688
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0032487
UMLS CUI [3,1]
C0040300
UMLS CUI [3,2]
C0443286
UMLS CUI [3,3]
C0010106
UMLS CUI [4,1]
C0040300
UMLS CUI [4,2]
C0443286
UMLS CUI [4,3]
C0009072
have other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible
Description

CNS disorder | Substance Dependence | Evaluation Joint replacement Difficult | Evaluation Joint replacement Unsuccessful

Type de données

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0038580
UMLS CUI [3,1]
C1261322
UMLS CUI [3,2]
C1442800
UMLS CUI [3,3]
C0332218
UMLS CUI [4,1]
C1261322
UMLS CUI [4,2]
C1442800
UMLS CUI [4,3]
C1272705
are currently participating in another clinical study
Description

Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
are taking > 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery
Description

Adrenal Cortex Hormones U/day | Prednisone | Inhaler Excluded

Type de données

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0456683
UMLS CUI [2]
C0032952
UMLS CUI [3,1]
C0021461
UMLS CUI [3,2]
C0332196
are currently involved in any personal injury litigation, medical legal or worker's compensation claims.
Description

Personal injury Litigation Involved | Other Coding | Involvement with Worker Compensation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0680559
UMLS CUI [1,2]
C0079706
UMLS CUI [1,3]
C1314939
UMLS CUI [2]
C3846158
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0043233
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Similar models

Eligibility Osteoarthritis NCT00719771

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Arthroplasty of the shoulder Primary | Osteoarthritis | Informed Consent
Item
patients selected for inclusion will present for primary shoulder arthroplasty with a diagnosis of osteoarthritis and will consent to participate.
boolean
C0186662 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0029408 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Age
Item
are under 18 years of age or over 70
boolean
C0001779 (UMLS CUI [1])
Avascular necrosis | Arthritis | Fracture | Malunion
Item
diagnosis of avn, inflammatory arthritis, fracture or malunion.
boolean
C3887513 (UMLS CUI [1])
C0003864 (UMLS CUI [2])
C0016658 (UMLS CUI [3])
C3898471 (UMLS CUI [4])
Hemiarthroplasty
Item
have a hemi-arthroplasty
boolean
C0744743 (UMLS CUI [1])
Destruction Proximal humerus | Humeral component fixation Excluded
Item
have destruction of the proximal humerus that precludes rigid fixation of the humeral component
boolean
C0238790 (UMLS CUI [1,1])
C0588209 (UMLS CUI [1,2])
C0449344 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Arthritis | Rotator Cuff tissue Insufficient
Item
have arthritis with insufficient cuff tissue
boolean
C0003864 (UMLS CUI [1])
C0085515 (UMLS CUI [2,1])
C0040300 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
Rotator Cuff Operative Surgical Procedures failed
Item
have had a failed rotator cuff surgery
boolean
C0085515 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Loss Musculature Limb Affected | Neuromuscular impairment Limb Affected | Vascular deficiency Limb Affected | Procedure Impaired
Item
have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified
boolean
C1517945 (UMLS CUI [1,1])
C1995013 (UMLS CUI [1,2])
C0015385 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,4])
C4062805 (UMLS CUI [2,1])
C0015385 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C1394931 (UMLS CUI [3,1])
C0015385 (UMLS CUI [3,2])
C0392760 (UMLS CUI [3,3])
C0184661 (UMLS CUI [4,1])
C0221099 (UMLS CUI [4,2])
Communicable Disease
Item
have evidence of active infection
boolean
C0009450 (UMLS CUI [1])
Neuromuscular impairment Shoulder | Neuropathic joints | Injury of brachial plexus Associated with Flail shoulder joint | Neoplasm Metastasis | Neoplastic disease
Item
present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint) - have a known active metastatic or neoplastic disease
boolean
C4062805 (UMLS CUI [1,1])
C0037004 (UMLS CUI [1,2])
C0149739 (UMLS CUI [2])
C0161446 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C2894970 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4])
C1882062 (UMLS CUI [5])
Compliance behavior Rehabilitation therapy Unwilling | Compliance behavior Rehabilitation therapy Unable | Postoperative follow-up visit failed
Item
are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow-up visits prescribed by the protocol
boolean
C1321605 (UMLS CUI [1,1])
C0034991 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0034991 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C2585426 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
Skeletal Immature
Item
are skeletally immature.
boolean
C0521324 (UMLS CUI [1,1])
C0205252 (UMLS CUI [1,2])
Allergic Reaction Metallic implant | Allergic Reaction Polyethylenes | Tissue Reaction Corrosion | Tissue Reaction Clothes
Item
have a known allergic reaction to implant metals, polyethylene or a tissue reaction to corrosion or wear products
boolean
C1527304 (UMLS CUI [1,1])
C3693688 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0032487 (UMLS CUI [2,2])
C0040300 (UMLS CUI [3,1])
C0443286 (UMLS CUI [3,2])
C0010106 (UMLS CUI [3,3])
C0040300 (UMLS CUI [4,1])
C0443286 (UMLS CUI [4,2])
C0009072 (UMLS CUI [4,3])
CNS disorder | Substance Dependence | Evaluation Joint replacement Difficult | Evaluation Joint replacement Unsuccessful
Item
have other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible
boolean
C0007682 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C1261322 (UMLS CUI [3,1])
C1442800 (UMLS CUI [3,2])
C0332218 (UMLS CUI [3,3])
C1261322 (UMLS CUI [4,1])
C1442800 (UMLS CUI [4,2])
C1272705 (UMLS CUI [4,3])
Study Subject Participation Status
Item
are currently participating in another clinical study
boolean
C2348568 (UMLS CUI [1])
Adrenal Cortex Hormones U/day | Prednisone | Inhaler Excluded
Item
are taking > 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery
boolean
C0001617 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0032952 (UMLS CUI [2])
C0021461 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Personal injury Litigation Involved | Other Coding | Involvement with Worker Compensation
Item
are currently involved in any personal injury litigation, medical legal or worker's compensation claims.
boolean
C0680559 (UMLS CUI [1,1])
C0079706 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
C1314939 (UMLS CUI [3,1])
C0043233 (UMLS CUI [3,2])
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