BOND Study: the Benefit Of Night Splinting in Dupuytrens'

The Effectiveness of Night Splinting After Collagenase Injection for Dupuytren's Contracture

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03031080

Acronym

BOND

Enrollment

Registered

2017-01-25

Start date

2017-06-01

Completion date

2019-06-30

Last updated

2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytren Contracture

Keywords

Collagenase, Night-splinting, Dupuytrens, Contracture

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.

Interventions

DEVICEThermoplastic Hand Splint

Thermoplastic Night splint created and moulded to the individual patients hand in-house using generic thermoplastic.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Investigator, Outcomes 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.

Intervention model description

Randomised Controlled Trial - Block Randomisation

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

1. Single digit contractures greater than 30 degrees 2. No prior surgery for their contractures. 3. Successful collagenase and manipulation therapy (contracture reduced to within 10 degrees of full extension).

Exclusion criteria

1. Multiple digit contractures 2. Prior surgery for their contractures. 3. Failure of collagenase and manipulation therapy (contracture not reduced to within 10 degrees of full extension). 4. Inability to consent to treatment.

Design outcomes

Primary

Measure	Time frame	Description
Range of motion	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

Secondary

Measure	Time frame	Description
PEM Questionnaire	At 0 weeks, 12 weeks and 52 weeks	Patient Evaluation Measure to give disability score
URAM Questionnaire	At 0 weeks, 12 weeks and 52 weeks	Hand specific outcome questionnaire to assess quality of life outcomes

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026