Gebruik van triamcinolon met verlengde afgifte bij de behandeling van rotator cuff-ziekte

Patients receiving the 32-unit injection of FX006.

One injection of extended release triamcinolone. 32 milligram injection of the extended release triamcinolone in a 75:25 ratio of polylactic-co-glycolic acid (PLGA) microspheres to drug load of 25%. The drug product is reconstituted with diluent containing an isotonic, sterile aqueous solution of sodium chloride, carboxymethylcellulose sodium and polysorbate-80 to form a suspension prior to injection.

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Assess the overall safety extended release triamcinolone in acetate (TA-ER/FX006) in patient with rotator cuff disease. Safety is evaluated on the basis of incidence of adverse events (AE). These would be reported by the patient or discovered by the investigator from the following measure below: VAS (Visual Analogue Scale) is a scale to measure patient's pain. SANE (Single Assessment Numeric Evaluation) a scale of 0 to 100 that patients rate their joint function, with 100 being normal function. VR12 (Veterans RAND 12 Item Health Survey) is a patient-reported measure of a patient's overall health. ASES (American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) is a survey which measures function and pain in the shoulder. Surveys could indicate an AE if there was increasing pain or worsening function which would not be expected. This would direct the investigator into further physical exam and inquiry on possible injuries or any other AE. Outcomes will not be aggregated.

Assess changes in shoulder pain. Change in shoulder pain as measured by VAS. The VAS (Visual Analogue Scale for pain) is a continuous scale to measure patient's pain. The scale is from 0 to 100 with 100 being the worst pain and 0 being no pain.

Assess changes in shoulder function. Change in shoulder function as measured by SANE. SANE (Single Assessment Numeric Evaluation) is a scale of 0 to 100 that patients rate their knee function, with 100 being normal function and 0 being no function.

The Veterans RAND 12-Item Health Survey (VR-12) is a self-reported measure of health-related quality of life consisting of 12 items covering 8 health domains. Responses are summarized into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. Both are norm-based T-scores, standardized to a mean of 50 and a standard deviation of 10 in the U.S. general population, with a possible range of 0 to 100. For both PCS and MCS, higher scores indicate better health (a better outcome). Scores above the mean of 50 (e.g., 1 SD above = 60) represent better-than-average health, and scores below 50 (e.g., 1 SD below = 40) represent worse-than-average health.

ASES (American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form) is a patient-reported questionnaire that measures shoulder pain and function on a 0-100 scale, with 50 points for each. Higher scores indicate less pain and better function; lower scores indicate worse outcomes.

There are two sections to the form; pain and activities of daily living. The pain section includes four yes or no questions regarding timing of pain and pain medication, and one question involving a VAS scale from 0 (no pain) to 10 (worst pain). The activities of daily living section has 10 questions and is ranked on a 0 (unable to perform) to 3 (no difficulty performing) scale.