MedPath

Survey of Osteoarthritis Real World Therapies (SORT)

Completed
Conditions
osteoarthritis of the knee
10023213
Registration Number
NL-OMON38125
Lead Sponsor
Syreon Corporation
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
200
Inclusion Criteria

INCLUSION CRITERIA
1. Male or female subjects who are at least 50 years of age at the time of enrollment.
2. Subjects with a clinical diagnosis of primary osteoarthritis of the knee(s) .
3. Subjects who are presently receiving prescribed oral or topical analgesics for a minimum duration of two weeks prior to enrollment.
4. Subjects who have provided informed consent and are willing and able to follow the protocol.

Exclusion Criteria

EXCLUSION CRITERIA
1. Subjects with any arthritis other than primary osteoarthritis.
2. Subjects who are or have been treated with DMARDS, methotrexate or biologics.
3. Subjects considered by the investigator to be unwilling or unable to complete the study or unable to comprehend or complete the study questionnaires.
4. Subjects who are unwilling to comply with the protocol or who are unable to complete the questionnaires.
5. Subjects with active litigation and compensation issues including disability dispute cases with government.
6. Subjects with subtotal or total joint replacement in the affected knee.
7. Subjects with chronic severe pain of other causes that in the opinion of the investigator may require long-term analgesia or confound the present study.
8. Subjects currently enrolled in a clinical trial or who have participated in a clinical trial within the past 30 days.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary Objective:<br /><br>Among patients with symptomatic osteoarthritis of the knee(s) who are<br /><br>prescribed oral or topical analgesics for their symptoms, characterize over a<br /><br>12-month follow-up period the clinical care and outcomes of patients who report<br /><br>inadequate pain relief (as defined by BPI *Average Pain* score) at baseline.</p><br>
Secondary Outcome Measures
NameTimeMethod
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