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Trial record 2 of 85 for:    dupuytren | Recruiting, Not yet recruiting, Available Studies

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

This study is not yet open for participant recruitment.
Verified January 2017 by Royal Liverpool and Broadgreen University Hospitals NHS Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT03031080
First Posted: January 25, 2017
Last Update Posted: January 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Royal Liverpool and Broadgreen University Hospitals NHS Trust
  Purpose
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.

Condition Intervention
Dupuytren Contracture Device: Thermoplastic Hand Splint

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomised Controlled Trial - Block Randomisation
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Supportive Care
Official Title: The Effectiveness of Night Splinting After Collagenase Injection for Dupuytren's Contracture

Resource links provided by NLM:


Further study details as provided by Royal Liverpool and Broadgreen University Hospitals NHS Trust:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • PEM Questionnaire [ Time Frame: At 0 weeks, 12 weeks and 52 weeks ]
    Patient Evaluation Measure to give disability score

  • URAM Questionnaire [ Time Frame: At 0 weeks, 12 weeks and 52 weeks ]
    Hand specific outcome questionnaire to assess quality of life outcomes


Estimated Enrollment: 60
Anticipated Study Start Date: March 1, 2017
Estimated Study Completion Date: June 30, 2019
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031080


Contacts
Contact: Daniel Brown, MBBCh, FRCS 01517062000 ext 3697 daniel.brown@rlbuht.nhs.uk
Contact: RD&I Governance Manager 01517062000 ext 3320 RGT@rlbuht.nhs.uk

Sponsors and Collaborators
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Investigators
Principal Investigator: Graham Cheung, MBBCh FRCS Consultant Hand Surgeon
  More Information

Responsible Party: Royal Liverpool and Broadgreen University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03031080     History of Changes
Other Study ID Numbers: 5396
First Submitted: January 23, 2017
First Posted: January 25, 2017
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Royal Liverpool and Broadgreen University Hospitals NHS Trust:
Collagenase, Night-splinting, Dupuytrens, Contracture

Additional relevant MeSH terms:
Dupuytren Contracture
Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases