BOND Study: the Benefit Of Night Splinting in Dupuytrens'

NCT03031080 | Withdrawn

• 1 other identifier: 5396
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Dupuytren Contracture

Keywords

Collagenase, Night-splinting, Dupuytrens, Contracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• PEM Questionnaire

  At 0 weeks, 12 weeks and 52 weeks

• URAM Questionnaire

  At 0 weeks, 12 weeks and 52 weeks

Study Arms (2)

Splinted

ACTIVE COMPARATOR

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

Device: Thermoplastic Hand Splint

Un-Splinted

NO INTERVENTION

Patients will not wear a night splint

Interventions

Thermoplastic Hand Splint DEVICE

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

Splinted

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Royal Liverpool & Broadgreen University Hospitals NHS Trust

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

MeSH Terms

Conditions

Dupuytren Contracture; Contracture

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Joint Diseases

Study Officials

• Graham Cheung, MBBCh FRCS

  Consultant Hand Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomised Controlled Trial - Block Randomisation

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 25, 2017
• Study Start: June 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: June 30, 2019
• Last Updated: September 27, 2021

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)