ID

41155

Description

Clinical Outcomes in Shoulder Hemi-arthroplasty Using a PyC Spherical Interpositional Implant; ODM derived from: https://clinicaltrials.gov/show/NCT02424760

Link

https://clinicaltrials.gov/show/NCT02424760

Keywords

  1. 7/2/20 7/2/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 2, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility Localized, Primary Osteoarthritis NCT02424760

Eligibility Localized, Primary Osteoarthritis NCT02424760

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients requiring a humeral head replacement (hhr) with inspyre as per indication of the instruction for use:
Description

Requirement Humeral head Replacement

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0223683
UMLS CUI [1,3]
C0035139
with degenerative indication such as primary gleno humeral (gh) osteoarthritis, post-traumatic arthritis, primary and secondary avascular osteonecrosis of the humeral head,
Description

Osteoarthritis of glenohumeral joint | Arthritis Posttraumatic | Avascular necrosis of bone Primary Humeral head | Avascular necrosis of bone Secondary Humeral head

Data type

boolean

Alias
UMLS CUI [1]
C0409939
UMLS CUI [2,1]
C0003864
UMLS CUI [2,2]
C0231288
UMLS CUI [3,1]
C0027543
UMLS CUI [3,2]
C0205225
UMLS CUI [3,3]
C0223683
UMLS CUI [4,1]
C0027543
UMLS CUI [4,2]
C0175668
UMLS CUI [4,3]
C0223683
presenting a functional rotator cuff,
Description

Rotator Cuff Functional

Data type

boolean

Alias
UMLS CUI [1,1]
C0085515
UMLS CUI [1,2]
C0205245
able to return for all scheduled and required study visit;
Description

Adherence Clinical Trial Visits

Data type

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0008952
having provided informed consent about scientific study participation if applicable.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute proximal humeral fracture,
Description

Humeral Fracture Proximal

Data type

boolean

Alias
UMLS CUI [1,1]
C0020162
UMLS CUI [1,2]
C0205107
systemic or local infection,
Description

Sepsis | Local infection

Data type

boolean

Alias
UMLS CUI [1]
C0243026
UMLS CUI [2]
C1400591
rotator cuff tear,
Description

Nontraumatic rotator cuff tear

Data type

boolean

Alias
UMLS CUI [1]
C1828213
instability of the humeral head,
Description

Instability Humeral head

Data type

boolean

Alias
UMLS CUI [1,1]
C1444783
UMLS CUI [1,2]
C0223683
axillary nerve palsy,
Description

Axillary nerve palsy

Data type

boolean

Alias
UMLS CUI [1]
C2062709
revision arthroplasty.
Description

Arthroplasty revision

Data type

boolean

Alias
UMLS CUI [1,1]
C0003893
UMLS CUI [1,2]
C0558347

Similar models

Eligibility Localized, Primary Osteoarthritis NCT02424760

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Requirement Humeral head Replacement
Item
patients requiring a humeral head replacement (hhr) with inspyre as per indication of the instruction for use:
boolean
C1514873 (UMLS CUI [1,1])
C0223683 (UMLS CUI [1,2])
C0035139 (UMLS CUI [1,3])
Osteoarthritis of glenohumeral joint | Arthritis Posttraumatic | Avascular necrosis of bone Primary Humeral head | Avascular necrosis of bone Secondary Humeral head
Item
with degenerative indication such as primary gleno humeral (gh) osteoarthritis, post-traumatic arthritis, primary and secondary avascular osteonecrosis of the humeral head,
boolean
C0409939 (UMLS CUI [1])
C0003864 (UMLS CUI [2,1])
C0231288 (UMLS CUI [2,2])
C0027543 (UMLS CUI [3,1])
C0205225 (UMLS CUI [3,2])
C0223683 (UMLS CUI [3,3])
C0027543 (UMLS CUI [4,1])
C0175668 (UMLS CUI [4,2])
C0223683 (UMLS CUI [4,3])
Rotator Cuff Functional
Item
presenting a functional rotator cuff,
boolean
C0085515 (UMLS CUI [1,1])
C0205245 (UMLS CUI [1,2])
Adherence Clinical Trial Visits
Item
able to return for all scheduled and required study visit;
boolean
C1510802 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0008952 (UMLS CUI [1,3])
Informed Consent
Item
having provided informed consent about scientific study participation if applicable.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Humeral Fracture Proximal
Item
acute proximal humeral fracture,
boolean
C0020162 (UMLS CUI [1,1])
C0205107 (UMLS CUI [1,2])
Sepsis | Local infection
Item
systemic or local infection,
boolean
C0243026 (UMLS CUI [1])
C1400591 (UMLS CUI [2])
Nontraumatic rotator cuff tear
Item
rotator cuff tear,
boolean
C1828213 (UMLS CUI [1])
Instability Humeral head
Item
instability of the humeral head,
boolean
C1444783 (UMLS CUI [1,1])
C0223683 (UMLS CUI [1,2])
Axillary nerve palsy
Item
axillary nerve palsy,
boolean
C2062709 (UMLS CUI [1])
Arthroplasty revision
Item
revision arthroplasty.
boolean
C0003893 (UMLS CUI [1,1])
C0558347 (UMLS CUI [1,2])

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