BOND Study: the Benefit Of Night Splinting in Dupuytrens'

Dupuytren Contracture Clinical Trial

— BOND  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03031080
• Other study ID #: 5396
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: April 2018
• Source: Liverpool University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture

Intervention

Device:
• Thermoplastic Hand Splint
Thermoplastic Night splint created and moulded to the individual patients hand in-house using generic thermoplastic.

Locations

Country	Name	City	State
United Kingdom	Royal Liverpool & Broadgreen University Hospitals NHS Trust	Liverpool	Merseyside

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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