ID

32365

Description

Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study; ODM derived from: https://clinicaltrials.gov/show/NCT02029469

Link

https://clinicaltrials.gov/show/NCT02029469

Keywords

Versions (1)
  1. 10/28/18 10/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 28, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Shoulder Arthritis Osteoarthritis NCT02029469

English

Eligibility Shoulder Arthritis Osteoarthritis NCT02029469

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the following patient will be included in the study - patient who:
Description

Patients Included

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332257
is treated with the ascension hra;
Description

Resurfacing shoulder humeral stem prosthesis

Data type

boolean

Alias
UMLS CUI [1]
C3875732
is disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis;
Description

Arthritis | Rheumatoid Arthritis | Osteoarthritis | Avascular necrosis

Data type

boolean

Alias
UMLS CUI [1]
C0003864
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0029408
UMLS CUI [4]
C3887513
has mild or moderate humeral head deformity and /or limited motion;
Description

Humeral head Deformity Mild | Humeral head Deformity Moderate | Humeral head Motion Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0223683
UMLS CUI [1,2]
C0302142
UMLS CUI [1,3]
C2945599
UMLS CUI [2,1]
C0223683
UMLS CUI [2,2]
C0302142
UMLS CUI [2,3]
C0205081
UMLS CUI [3,1]
C0223683
UMLS CUI [3,2]
C0026597
UMLS CUI [3,3]
C0439801
has post-traumatic arthritis;
Description

Posttraumatic arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0152086
has an intact or reparable rotator cuff;
Description

Rotator Cuff Intact

Data type

boolean

Alias
UMLS CUI [1,1]
C0085515
UMLS CUI [1,2]
C0205266
has the means and ability to return for all required study visits
Description

Ability Clinic Visits

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0008952
is willing to participate in the study;
Description

Study Subject Participation Status Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0600109
has signed an informed consent form;
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
is at least 18 years of age and skeletally mature at the time of surgery;
Description

Age | Skeleton Mature

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0816871
UMLS CUI [2,2]
C0205286
is less than 75 years of age at the time of surgery
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the following patients will be excluded from the study - patients who:
Description

Patients Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332196
infection, sepsis, and osteomyelitis;
Description

Communicable Disease | Sepsis | Osteomyelitis

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0243026
UMLS CUI [3]
C0029443
osteoporosis;
Description

Osteoporosis

Data type

boolean

Alias
UMLS CUI [1]
C0029456
metabolic disorders which may impair bone formation;
Description

Metabolic Diseases Impairing Bone formation

Data type

boolean

Alias
UMLS CUI [1,1]
C0025517
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0029433
osteomalacia;
Description

Osteomalacia

Data type

boolean

Alias
UMLS CUI [1]
C0029442
rapid joint destruction, marked bone loss or bone resorption apparent on x-ray;
Description

Joint destruction Rapid X-ray | Bone loss Marked X-ray | Bone Resorption X-ray

Data type

boolean

Alias
UMLS CUI [1,1]
C0541875
UMLS CUI [1,2]
C0456962
UMLS CUI [1,3]
C0034571
UMLS CUI [2,1]
C0029453
UMLS CUI [2,2]
C1706089
UMLS CUI [2,3]
C0034571
UMLS CUI [3,1]
C0005974
UMLS CUI [3,2]
C0034571
revision procedures where other devices or treatments have failed
Description

Revision procedure | Medical Devices failed | Treatment failed

Data type

boolean

Alias
UMLS CUI [1]
C1527075
UMLS CUI [2,1]
C0025080
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0231175
refuses to be in the study; or does not have the means and ability to return for all required study visits;
Description

Refusal to Participate Clinical Trial | Clinic Visits Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C1136454
UMLS CUI [1,2]
C0008976
UMLS CUI [2,1]
C0008952
UMLS CUI [2,2]
C1299582
currently participating in another clinical study.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Shoulder Arthritis Osteoarthritis NCT02029469

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patients Included
Item
the following patient will be included in the study - patient who:
boolean
C0030705 (UMLS CUI [1,1])
C0332257 (UMLS CUI [1,2])
Resurfacing shoulder humeral stem prosthesis
Item
is treated with the ascension hra;
boolean
C3875732 (UMLS CUI [1])
Arthritis | Rheumatoid Arthritis | Osteoarthritis | Avascular necrosis
Item
is disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis;
boolean
C0003864 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0029408 (UMLS CUI [3])
C3887513 (UMLS CUI [4])
Humeral head Deformity Mild | Humeral head Deformity Moderate | Humeral head Motion Limited
Item
has mild or moderate humeral head deformity and /or limited motion;
boolean
C0223683 (UMLS CUI [1,1])
C0302142 (UMLS CUI [1,2])
C2945599 (UMLS CUI [1,3])
C0223683 (UMLS CUI [2,1])
C0302142 (UMLS CUI [2,2])
C0205081 (UMLS CUI [2,3])
C0223683 (UMLS CUI [3,1])
C0026597 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
Posttraumatic arthritis
Item
has post-traumatic arthritis;
boolean
C0152086 (UMLS CUI [1])
Rotator Cuff Intact
Item
has an intact or reparable rotator cuff;
boolean
C0085515 (UMLS CUI [1,1])
C0205266 (UMLS CUI [1,2])
Ability Clinic Visits
Item
has the means and ability to return for all required study visits
boolean
C0085732 (UMLS CUI [1,1])
C0008952 (UMLS CUI [1,2])
Study Subject Participation Status Willing
Item
is willing to participate in the study;
boolean
C2348568 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Informed Consent
Item
has signed an informed consent form;
boolean
C0021430 (UMLS CUI [1])
Age | Skeleton Mature
Item
is at least 18 years of age and skeletally mature at the time of surgery;
boolean
C0001779 (UMLS CUI [1])
C0816871 (UMLS CUI [2,1])
C0205286 (UMLS CUI [2,2])
Age
Item
is less than 75 years of age at the time of surgery
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Patients Excluded
Item
the following patients will be excluded from the study - patients who:
boolean
C0030705 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Communicable Disease | Sepsis | Osteomyelitis
Item
infection, sepsis, and osteomyelitis;
boolean
C0009450 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
C0029443 (UMLS CUI [3])
Osteoporosis
Item
osteoporosis;
boolean
C0029456 (UMLS CUI [1])
Metabolic Diseases Impairing Bone formation
Item
metabolic disorders which may impair bone formation;
boolean
C0025517 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0029433 (UMLS CUI [1,3])
Osteomalacia
Item
osteomalacia;
boolean
C0029442 (UMLS CUI [1])
Joint destruction Rapid X-ray | Bone loss Marked X-ray | Bone Resorption X-ray
Item
rapid joint destruction, marked bone loss or bone resorption apparent on x-ray;
boolean
C0541875 (UMLS CUI [1,1])
C0456962 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C0029453 (UMLS CUI [2,1])
C1706089 (UMLS CUI [2,2])
C0034571 (UMLS CUI [2,3])
C0005974 (UMLS CUI [3,1])
C0034571 (UMLS CUI [3,2])
Revision procedure | Medical Devices failed | Treatment failed
Item
revision procedures where other devices or treatments have failed
boolean
C1527075 (UMLS CUI [1])
C0025080 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
Refusal to Participate Clinical Trial | Clinic Visits Unable
Item
refuses to be in the study; or does not have the means and ability to return for all required study visits;
boolean
C1136454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0008952 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Study Subject Participation Status
Item
currently participating in another clinical study.
boolean
C2348568 (UMLS CUI [1])
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