BOND Study: the Benefit Of Night Splinting in Dupuytrens' (BOND)

September 21, 2021 updated by: Liverpool University Hospitals NHS Foundation Trust

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L7 8XP
        • Royal Liverpool & Broadgreen University Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Splinted
Patients will be given Thermoplastic Hand Splint to wear overnight for 12 weeks.
Device: Thermoplastic Hand Splint
Thermoplastic Night splint created and moulded to the individual patients hand in-house using generic thermoplastic.
NO_INTERVENTION: Un-Splinted
Patients will not wear a night splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 0 weeks, 12 weeks and 52 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool University Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: Graham Cheung, MBBCh FRCS, Consultant Hand Surgeon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ANTICIPATED)

December 31, 2018

Study Completion (ANTICIPATED)

June 30, 2019

Study Registration Dates

First Submitted

January 23, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (ESTIMATE)

January 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5396

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dupuytren Contracture

Clinical Trials on Thermoplastic Hand Splint

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe