Back to resultsBOND Study: the Benefit Of Night Splinting in Dupuytrens' (BOND)
Primary Purpose
Dupuytren Contracture
Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Thermoplastic Hand Splint
Sponsored by
About this trial
This is an interventional supportive care trial for Dupuytren Contracture focused on measuring Collagenase, Night-splinting, Dupuytrens, Contracture
Eligibility Criteria
Inclusion Criteria:
- Single digit contractures greater than 30 degrees
- No prior surgery for their contractures.
- Successful collagenase and manipulation therapy (contracture reduced to within 10 degrees of full extension).
Exclusion Criteria:
- Multiple digit contractures
- Prior surgery for their contractures.
- Failure of collagenase and manipulation therapy (contracture not reduced to within 10 degrees of full extension).
- Inability to consent to treatment.
Sites / Locations
- Royal Liverpool & Broadgreen University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Splinted
Un-Splinted
Arm Description
Patients will be given Thermoplastic Hand Splint to wear overnight for 12 weeks.
Patients will not wear a night splint
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
PEM Questionnaire
Patient Evaluation Measure to give disability score
URAM Questionnaire
Hand specific outcome questionnaire to assess quality of life outcomes
Full Information
NCT ID
NCT03031080
First Posted
January 23, 2017
Last Updated
September 21, 2021
Sponsor
Liverpool University Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03031080
Brief Title
BOND Study: the Benefit Of Night Splinting in Dupuytrens'
Acronym
BOND
Official Title
The Effectiveness of Night Splinting After Collagenase Injection for Dupuytren's Contracture
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Intervention (Xiapex) was removed from the market
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool University Hospitals NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
This trial will assess the effectiveness of night splinting in Dupuytrens' contracture on functional and quality of life outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytren Contracture
Keywords
Collagenase, Night-splinting, Dupuytrens, Contracture
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Controlled Trial - Block Randomisation
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Splinted
Arm Type
Active Comparator
Arm Description
Patients will be given Thermoplastic Hand Splint to wear overnight for 12 weeks.
Arm Title
Un-Splinted
Arm Type
No Intervention
Arm Description
Patients will not wear a night splint
Intervention Type
Device
Intervention Name(s)
Thermoplastic Hand Splint
Intervention Description
Thermoplastic Night splint created and moulded to the individual patients hand in-house using generic thermoplastic.
Primary Outcome Measure Information:
Title
Range of motion
Description
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
Time Frame
At 0 weeks, 12 weeks and 52 weeks
Secondary Outcome Measure Information:
Title
PEM Questionnaire
Description
Patient Evaluation Measure to give disability score
Time Frame
At 0 weeks, 12 weeks and 52 weeks
Title
URAM Questionnaire
Description
Hand specific outcome questionnaire to assess quality of life outcomes
Time Frame
At 0 weeks, 12 weeks and 52 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Single digit contractures greater than 30 degrees
No prior surgery for their contractures.
Successful collagenase and manipulation therapy (contracture reduced to within 10 degrees of full extension).
Exclusion Criteria:
Multiple digit contractures
Prior surgery for their contractures.
Failure of collagenase and manipulation therapy (contracture not reduced to within 10 degrees of full extension).
Inability to consent to treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham Cheung, MBBCh FRCS
Organizational Affiliation
Consultant Hand Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Liverpool & Broadgreen University Hospitals NHS Trust
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L7 8XP
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BOND Study: the Benefit Of Night Splinting in Dupuytrens'
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