Study of treatments for Dupuytren’s contractures

Hand-2: Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers: a randomised, multi-centre non-inferiority trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12525655

Enrollment

406

Registered

2020-09-18

Start date

2021-04-01

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytren’s contractures Musculoskeletal Diseases

Interventions

There are two different treatments for Dupuytren's contracture that are most commonly used in the NHS. However, there is no strong evidence about which of these treatments is best for patients or the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years 2. One or more fingers with a Dupuytren’s contracture of >30 with functional problems 3. No previous treatment for Dupuytren’s contracture on affected finger 4. Well defined cord(s) and suitable for NF (needle fasciotomy) or LF (limited fasciectomy) 5. Able to comply with the requirements of the study up to 24 months post-intervention

Exclusion criteria

Exclusion criteria: 1. Dupuytren’s contracture of the distal interphalangeal joints (DIP) only 2. Planned dermofasciectomy or very limited fasciectomy (excision of <1 cm cord segment) 3. Previously recruited into this study for treatment of either hand

Design outcomes

Secondary

Measure	Time frame
1. Participant-reported hand function and hand health measured using the Hand Health Profile of the PEM at 3 weeks, 6 weeks, 3 months, 6 months and 24 months post-treatment intervention 2. Participant-reported assessment of location-specific health (the hand) using the Single Assessment Numeric Evaluation (SANE) tool and the Measure Yourself Medical Outcome Profile (MYMOP) tool at 2 weeks, 3 weeks, 4 weeks, 6 weeks, 3 months, 6 months and 24 months post-treatment intervention 3. Loss of finger extension using measuring tool (SLiCK device) at 6 weeks, and 6, 12 and 24 months post-treatment intervention 4. Adverse events and complications, recurrence of DC, and revisions or salvage surgery recorded in the Case Report Form and participant questionnaire responses up to 24 months post-treatment intervention 5. Health-related quality of life, health resource use, and cost-effectiveness assessed by a health economic analysis of health & social services costs at 2 weeks, 3 weeks 6 weeks, 6 months, 12 and 24 months post-treatment intervention	—

Measure

Time frame

1. Participant-reported hand function and hand health measured using the Hand Health Profile of the PEM at 3 weeks, 6 weeks, 3 months, 6 months and 24 months post-treatment intervention 2. Participant-reported assessment of location-specific health (the hand) using the Single Assessment Numeric Evaluation (SANE) tool and the Measure Yourself Medical Outcome Profile (MYMOP) tool at 2 weeks, 3 weeks, 4 weeks, 6 weeks, 3 months, 6 months and 24 months post-treatment intervention 3. Loss of finger extension using measuring tool (SLiCK device) at 6 weeks, and 6, 12 and 24 months post-treatment intervention 4. Adverse events and complications, recurrence of DC, and revisions or salvage surgery recorded in the Case Report Form and participant questionnaire responses up to 24 months post-treatment intervention 5. Health-related quality of life, health resource use, and cost-effectiveness assessed by a health economic analysis of health & social services costs at 2 weeks, 3 weeks 6 weeks, 6 months, 12 and 24 months post-treatment intervention

—

Primary

Measure	Time frame
Participant-reported assessment of hand function using the PEM questionnaire at 12 months post-treatment intervention	—

Countries

England, Scotland, United Kingdom

Contacts

Public ContactAisha Shafayat

hand2@nottingham.ac.uk+44 (0)115 8231578

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026