BOND Study: the Benefit Of Night Splinting in Dupuytrens'

Not Applicable

Withdrawn

• Conditions: Dupuytren Contracture
• Interventions: Device: Thermoplastic Hand Splint

• Registration Number: NCT03031080
• Lead Sponsor: Liverpool University Hospitals NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-25
• Study Start: 2017-06-01
• Status Verified: 2018-04
• Primary Completion: 2018-12-31
• Study Completion: 2019-06-30
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Splinted	Thermoplastic Hand Splint	Patients will be given Thermoplastic Hand Splint to wear overnight for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Royal Liverpool & Broadgreen University Hospitals NHS Trust; 🇬🇧 Liverpool, Merseyside, United Kingdom