The objectives of this study are to assess the safety and efficacy of concurrent administration of two injections of AA4500 into the same hand of subjects with multiple Dupuytren's contractures caused by palpable cords.
Methodology/Study Design: This is an open-label, study in men and women with multiple Dupuytren's contractures. Approximately 60 subjects who have at least two Dupuytren's contractures caused by palpable cords in the same hand will be enrolled. After all pre-injection procedures are completed on Day 1, eligible men and women will receive two concurrent injections of AA4500 0.58 mg into the same hand. On Day 2, a finger extension procedure to facilitate cord disruption will be performed in those subjects who do not have spontaneous disruption of their cord(s). Follow-up visits for the evaluation of safety and efficacy will be on Day 8, Day 30, and Day 60. Upon completion of the Day 60 follow-up visit, subjects who require further treatment will have the option to receive three additional open-label treatments according to the XIAFLEX package insert (Appendix C). Subjects may receive up to a total of five injections and individual cords may receive up to a total of three injections.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
2 concurrent injections (0.58 mg) into 2 cords on the same hand
Tucson Orthopaedic Institute
Tucson, Arizona, United States
The Indiana Hand Center
Indianapolis, Indiana, United States
Department of Orthopaedics SUNY-Stony Brook
Stony Brook, New York, United States
Health Research Institute
Oklahoma City, Oklahoma, United States
Percent Change From Baseline in Total Fixed Flexion
Total fixed flexion is defined as the sum of the fixed flexion contractures of the two joints receiving treatment. Change in fixed-flexion contracture is measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees
Time frame: 30 days after last injection
Change in Total Range of Motion
The total range of motion is the sum of the range of motion measurements of the two treated joints. Range of motion is defined as difference between full flexion angle and full extension angle expressed in degrees.
Time frame: 30 days after last injection
Subject Satisfaction With Treatment
At the Day 60 follow-up visit, each subject will be asked to rate his/her satisfaction with treatment as follows: 1. Very Satisfied 2. Quite Satisfied 3. Neither Satisfied nor Dissatisfied 4. Quite Dissatisfied 5. Very Dissatisfied
Time frame: 60 days after last injection
Investigator Assessment of Improvement With Treatment
At the Day 60 follow-up visit, the investigator will determine the degree of improvement in the severity of the subject's treated finger(s) compared with screening as follows: 1. Very Much Improved 2. Much improved 3. Minimally Improved 4. No Change 5. Minimally Worse 6. Much Worse 7. Very Much Worse
Time frame: 60 days after last injection
Clinical Success by Joint Type
Clinical success is defined as a reduction in fixed flexion contracture to 5° or less 30 days after injection of AA4500.
Time frame: 30 days after injection
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