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Intervention (Xiapex) was removed from the market
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The BOND study is a prospective, randomised single blinded controlled trial to assess the effect of night splinting in patients who have had collagenase injection and manipulation therapy for Dupuytren's Contracture.
This trial will assess the effectiveness of night splinting in Dupuytrens' contracture on functional and quality of life outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Splinted | Active Comparator | Patients will be given Thermoplastic Hand Splint to wear overnight for 12 weeks. |
|
| Un-Splinted | No Intervention | Patients will not wear a night splint |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermoplastic Hand Splint | Device | Thermoplastic Night splint created and moulded to the individual patients hand in-house using generic thermoplastic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Range of motion | To assess change in range of motion measured in degrees between pre-treatment, immediately post-treatment, 12 weeks post-treatment and 12 months post-treatment | At 0 weeks, 12 weeks and 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PEM Questionnaire | Patient Evaluation Measure to give disability score | At 0 weeks, 12 weeks and 52 weeks |
| URAM Questionnaire | Hand specific outcome questionnaire to assess quality of life outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Graham Cheung, MBBCh FRCS | Consultant Hand Surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Liverpool & Broadgreen University Hospitals NHS Trust | Liverpool | Merseyside | L7 8XP | United Kingdom |
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| ID | Term |
|---|---|
| D004387 | Dupuytren Contracture |
| D003286 | Contracture |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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Randomised Controlled Trial - Block Randomisation
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Initial heath-care provider and participant are not masked as would be impossible to do so. Outcome assessor (a different health care provider) and investigators will be masked as to whether the patient is in the splinted or unsplinted cohort.
| At 0 weeks, 12 weeks and 52 weeks |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007592 | Joint Diseases |