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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12618000951257p | Other Identifier | Australian government |
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This is a randomized study to determine whether radiation therapy reduces the risk of progression / recurrence of Dupuytren's disease / contracture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Therapy | Experimental | early stage DD (no flexion contraction in affected hand) - randomized to Radiotherapy |
|
| Standard of Care | No Intervention | Patients are receiving standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | Radiation therapy (RT) should commence within 12 weeks of randomization in the prevention group and within 12 weeks of local treatment (NA) for the adjuvant group. RT will consist of 30Gy in 10 equal fractions. The RT schedule will be 5 initial fractions, then a 4-12 week break and then the final 5 fractions. Each group of 5 treatments must be delivered within a 7 day period. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Passive Extension Deficit (PED) | Deterioration greater than 20 degrees Passive Extension Deficit (PED) in any joint(s) of any of the affected digit(s) from post-intervention baseline in the presence of a palpable cord OR instigation of salvage surgical fasciectomy (SF) or NA to any of the affected digit(s). | Day 0 (corresponding to the day of local treatment for intervention groups) and then at 6, 12, 24, 36, 48, 60, 84 and 108 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with any adverse events of interest | Number of participants with any adverse events of interest | Day 0 (corresponding to the day of local treatment for intervention groups) and then at 6, 12, 24, 36, 48, 60, 84 and 108 months |
| Mean Pain Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruce McGibbon, MD | Contact | 203-8633-701 | bruce.mcgibbon@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bruce McGibbon, MD | Yale University | Principal Investigator |
| Frank D Buono, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greenwich Hospital | Greenwich | Connecticut | 06830 | United States |
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| ID | Term |
|---|---|
| D004387 | Dupuytren Contracture |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
Mean Visual Analogue Scale (VAS 0-10) for pain, higher scores indicate more pain. |
| Day 0 (corresponding to the day of local treatment for intervention groups) and then at 6, 12, 24, 36, 48, 60, 84 and 108 months |
| Total Score Unité Rhumatologique des Affections de la Main (URAM) | URAM (total score) for Dupuytren's disease specific function, is a 9-item scale with total scores ranging from 0 to 45. Higher scores mean greater disability. | Day 0 (corresponding to the day of local treatment for intervention groups) and then at 6, 12, 24, 36, 48, 60, 84 and 108 months |
| Total Score QuickDASH | QuickDASH (total score) for physical fundctionand symptoms, is an 11 item scale with total score range 0-100. Higher scores mean more severe disability. | Day 0 (corresponding to the day of local treatment for intervention groups) and then at 6, 12, 24, 36, 48, 60, 84 and 108 months |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003286 | Contracture |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |