BOND Study: the Benefit Of Night Splinting in Dupuytrens'

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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This trial will assess the effectiveness of night splinting in Dupuytrens' contracture on functional and quality of life outcomes.

Conditions

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Dupuytren Contracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised Controlled Trial - Block Randomisation

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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Splinted

Patients will be given Thermoplastic Hand Splint to wear overnight for 12 weeks.

Group Type ACTIVE_COMPARATOR

Thermoplastic Hand Splint

Intervention Type DEVICE

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

Un-Splinted

Patients will not wear a night splint

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Thermoplastic Hand Splint

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes