NCT05300893 Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture
| NCT ID | NCT05300893 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uppsala University |
| Condition | Dupuytren Contracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2022-09-14 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 154 participants in total. It began in 2022-09-14 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Dupuytren's contracture (DC) is associated with progressive finger flexion and extension deficit caused by fibrosis in the palm and digits. Treatment options include minimally invasive procedures such as percutaneous needle fasciotomy (PNF) and collagenase clostridium histolyticum injections as well as open fasciectomy. PNF has recently become more popular in Sweden because it is an office-based procedure which is relatively easy to perform without the usual risks and costs of open surgery. After treatment with PNF patients usually continue with supervised rehabilitation, which includes physical therapy and night splinting. Whether night splinting is beneficial in terms of reducing recurrence of DC is currently debated. This study aims to investigate whether night splinting after performed PNF helps to reduce recurrence rate or not. Patients who meet the inclusion criteria will be randomized into two groups: The first group will be treated as usual with physical therapy and night splinting after PNF. The second group will be treated with physical therapy without night splinting after PNF. Follow up includes physical examination regarding active range of motion, sensation and grip strength at procedure day and 2 weeks, 3, 12 and 36 months later as well as questionnaires regarding hand function, pain and quality of life at procedure day and 3, 12 and 36 months later. Patients who are randomized into the second group (no night splinting) will also be examined 3 weeks after PNF for observation in case of an early impairment regarding extension deficit.
Eligibility Criteria
Inclusion Criteria: * 18 years of age and older, * Palpable Dupuytren strand with passive extension deficit according to stadium 1 and 2 of the classification of Tubiana in one or two fingers excluding the thumb, defined as at least 30 degrees in the MCP joint and/or at least 20 degrees in the PIP joint and a maximum of 75 degrees in the MCP or PIP joint Exclusion Criteria: * Multiple, invasive or wide strands in the palm, * Skin irritation, * Strand localization in the digit only, * Digital nerve injury, * Any former treatment for Dupuytren's contracture in the same digit, * Thumb contracture, * Stadium 3 and 4 according to the classification of Tubiana
Contact & Investigator
Stephan Wilbrand, MD, PhD
PRINCIPAL INVESTIGATOR
Uppsala University
Frequently Asked Questions
Who can join the NCT05300893 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dupuytren Contracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05300893 currently recruiting?
Yes, NCT05300893 is actively recruiting participants. Contact the research team at daniel.muder@surgsci.uu.se for enrollment information.
Where is the NCT05300893 trial being conducted?
This trial is being conducted at Falun, Sweden, Uppsala, Sweden, Örebro, Sweden.
Who is sponsoring the NCT05300893 clinical trial?
NCT05300893 is sponsored by Uppsala University. The principal investigator is Stephan Wilbrand, MD, PhD at Uppsala University. The trial plans to enroll 154 participants.