BOND Study: the Benefit Of Night Splinting in Dupuytrens'

Liverpool University Hospitals NHS Foundation Trust

Status: Withdrawn

Conditions: Dupuytren Contracture

Treatments: Device: Thermoplastic Hand Splint

Study type: Interventional

Funder types: Other

Identifiers

NCT03031080

5396

Details and patient eligibility

About

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.

Full description

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

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Splinted

Active Comparator group

Description:

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

Treatment:

Device: Thermoplastic Hand Splint

Un-Splinted

No Intervention group

Description:

Patients will not wear a night splint