Dupuytren ContractureBONDNCT03031080
BOND Study: the Benefit Of Night Splinting in Dupuytrens'
A study testing Thermoplastic Hand Splint in people with Dupuytren Contracture, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dupuytren Contracture
- What is being tested?
- Thermoplastic Hand Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Liverpool & Broadgreen University Hospitals NHS Trust
Liverpool, Merseyside, L7 8XP
About this study
Official title: The Effectiveness of Night Splinting After Collagenase Injection for Dupuytren's Contracture
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.
Read the detailed description
This trial will assess the effectiveness of night splinting in Dupuytrens' contracture on functional and quality of life outcomes.
- Conditions
- Dupuytren Contracture
- Being tested
- Thermoplastic Hand Splint
- Keywords
- Collagenase, Night-splinting, Dupuytrens, Contracture
- Medical subject headings
- Dupuytren Contracture, Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermoplastic Hand SplintDevice
Thermoplastic Night splint created and moulded to the individual patients hand in-house using generic thermoplastic.
| Study group | Role | What they receive |
|---|---|---|
| Splinted | Active comparator | Patients will be given Thermoplastic Hand Splint to wear overnight for 12 weeks. Receives: Device: Thermoplastic Hand Splint |
| Un-Splinted | No intervention | Patients will not wear a night splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 0 weeks, 12 weeks and 52 weeks
Secondary outcomes (2)
PEM Questionnaire
Patient Evaluation Measure to give disability score
Measured: At 0 weeks, 12 weeks and 52 weeks
URAM Questionnaire
Hand specific outcome questionnaire to assess quality of life outcomes
Measured: At 0 weeks, 12 weeks and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start1 Jun 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion30 Jun 2019 (estimated)
Why it stopped: Intervention (Xiapex) was removed from the market
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial - Block Randomisation
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Graham Cheung, MBBCh FRCS, Principal investigator, Consultant Hand Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031080
- Sponsor's protocol ID
- 5396
- Acronym
- BOND
- Status last verified
- Apr 2018
- First submitted
- 23 Jan 2017
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Night Splinting After Collagenase Injection for Dupuytren's Contracture
- ClinicalTrials.gov ID
- NCT03031080
- Acronym / sponsor ID
- BOND / 5396
- Conditions
- Dupuytren Contracture
- Keywords
- Collagenase, Night-splinting, Dupuytrens, Contracture
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Intervention (Xiapex) was removed from the market
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial - Block Randomisation
| Arm | Type | Receives |
|---|---|---|
| Splinted | Active comparator | Device: Thermoplastic Hand SplintPatients will be given Thermoplastic Hand Splint to wear overnight for 12 weeks. |
| Un-Splinted | No intervention | –Patients will not wear a night splint |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermoplastic Hand SplintThermoplastic Night splint created and moulded to the individual patients hand in-house using generic thermoplastic. | Device | Splinted |
Primary outcome
Range of motion
Time frame: At 0 weeks, 12 weeks and 52 weeks
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
2 secondary outcomes
PEM Questionnaire
Time frame: At 0 weeks, 12 weeks and 52 weeks
URAM Questionnaire
Time frame: At 0 weeks, 12 weeks and 52 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham Cheung, MBBCh FRCS principal investigator
Consultant Hand Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermoplastic Hand Splint in people with Dupuytren Contracture, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: At 0 weeks, 12 weeks and 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.