ID

15759

Description

Ascension® Post- Approval Study; PyroCarbon Metacarpophalangeal Total Joint Prosthesis; ODM derived from: https://clinicaltrials.gov/show/NCT02408471

Link

https://clinicaltrials.gov/show/NCT02408471

Keywords

Versions (1)
  1. 6/11/16 6/11/16 -
Uploaded on

June 11, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02408471

English

Eligibility Rheumatoid Arthritis NCT02408471

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
indications consistent with the fda approved indications for use: index, long, ring, or small finger metacarpophalangeal (mcp) joints that exhibit symptoms of pain, limited motion, or inadequate bony alignment (i.e., subluxation/dislocation) secondary to articular destruction or degenerative disease related to rheumatoid arthritis, systemic lupus erythematosus, osteoarthritis, or post-traumatic arthritis where soft tissue reconstruction can provide adequate stabilization
Description

degenerative disease related to rheumatoid arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0024141
UMLS CUI [3]
C0029408
willing to participate in the study
Description

willing to participate

Data type

boolean

Alias
UMLS CUI [1]
C0021430
signed an informed consent form
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
the means and ability to return for all required study visits
Description

follow-up

Data type

boolean

Alias
UMLS CUI [1]
C1522577
are not transient
Description

transient

Data type

boolean

Alias
UMLS CUI [1]
C0040704
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inadequate bone stock at the implantation site
Description

patients who have any of the following contraindications will be excluded from the study:

Data type

boolean

active infection in the mcp joint
Description

infection in the mcp joint

Data type

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C0025525
nonfunctioning and irreparable mcp musculotendinous system
Description

mcp musculotendinous system

Data type

boolean

Alias
UMLS CUI [1,1]
C0584646
UMLS CUI [1,2]
C0025525
physical interference with or by other prostheses during implantation or use
Description

other prostheses

Data type

boolean

Alias
UMLS CUI [1,1]
C0175649
UMLS CUI [1,2]
C0521102
procedures requiring modification of the prosthesis
Description

modification of the prosthesis

Data type

boolean

Alias
UMLS CUI [1,1]
C0175649
UMLS CUI [1,2]
C0579005
skin, bone, circulatory and/or neurological deficiency at the implantation site
Description

deficiency at the implantation site

Data type

boolean

Alias
UMLS CUI [1,1]
C0230992
UMLS CUI [1,2]
C0011155
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Similar models

Eligibility Rheumatoid Arthritis NCT02408471

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
degenerative disease related to rheumatoid arthritis
Item
indications consistent with the fda approved indications for use: index, long, ring, or small finger metacarpophalangeal (mcp) joints that exhibit symptoms of pain, limited motion, or inadequate bony alignment (i.e., subluxation/dislocation) secondary to articular destruction or degenerative disease related to rheumatoid arthritis, systemic lupus erythematosus, osteoarthritis, or post-traumatic arthritis where soft tissue reconstruction can provide adequate stabilization
boolean
C0003873 (UMLS CUI [1])
C0024141 (UMLS CUI [2])
C0029408 (UMLS CUI [3])
willing to participate
Item
willing to participate in the study
boolean
C0021430 (UMLS CUI [1])
informed consent
Item
signed an informed consent form
boolean
C0021430 (UMLS CUI [1])
follow-up
Item
the means and ability to return for all required study visits
boolean
C1522577 (UMLS CUI [1])
transient
Item
are not transient
boolean
C0040704 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
bone stock
Item
inadequate bone stock at the implantation site
boolean
infection in the mcp joint
Item
active infection in the mcp joint
boolean
C3714514 (UMLS CUI [1,1])
C0025525 (UMLS CUI [1,2])
mcp musculotendinous system
Item
nonfunctioning and irreparable mcp musculotendinous system
boolean
C0584646 (UMLS CUI [1,1])
C0025525 (UMLS CUI [1,2])
other prostheses
Item
physical interference with or by other prostheses during implantation or use
boolean
C0175649 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
modification of the prosthesis
Item
procedures requiring modification of the prosthesis
boolean
C0175649 (UMLS CUI [1,1])
C0579005 (UMLS CUI [1,2])
deficiency at the implantation site
Item
skin, bone, circulatory and/or neurological deficiency at the implantation site
boolean
C0230992 (UMLS CUI [1,1])
C0011155 (UMLS CUI [1,2])
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