A pilot randomized controlled trial comparing the effect of minimal invasive technique vs. standard (dermo)fasciectomy surgery in patients with secondary Dupuytren's contractur on convalescence, contraction correction and recurrence rate.

A pilot randomized controlled trial comparing the effect of a percutaneous and lipofilling technique in patients with a secondary Dupuytren’s contracture with standard fasciectomy surgery on convalenscence, contracture correction and recurrence rate.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20615

Enrollment

Registered

2010-02-12

Start date

2010-02-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Secondary/ recurrent Dupuytren's disease

Interventions

1. Intervention: Percutaneous lipofilling technique

2. Control: (Dermo) fasciectomy surgery.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Males and females; 2. Age; 3. Secondary Dupuytren's contracture; 4. PIP> 30º / MCP > 20º; 5. One or more affected diatheses; 6. ASA criteria I, II, and III.

Exclusion criteria

Exclusion criteria: 1. > 2 times surgery on affected ray; 2. congenital/trauma in past that affects the affected ray in a way that there is no 0 value; 3. Use of blood thinners that can not be stopped for surgery; 4. ASA IV and V; 5. severe CRPS in the past.

Design outcomes

Primary

Measure	Time frame
1. Convalescence (in days): VAS, 6 questions (diary); 2. Contracture reduction (in degrees): range motion (in degrees), boyes measure (in cm.), pictures.	—

Secondary

Measure	Time frame
1. Intervention (Register the anaesthetics drugs administered and vital signs during surgery, no protocol is used; Register the therapy used for PIP joint); 2. Hand sensibility and complications due to intervention: semmes weinstein ( 5 filaments (2.83; 3.61; 4.31; 4.56; 6.65)), volume (in cm.), DASH; 3. Patient satisfaction (VAS scale); 4. MRI and Echo (selection of the intervention group).	—

Contacts

Public ContactS.E.R. Hovius

PO BOX 2040

s.e.r.hovius@erasmusmc.nl+31 (0)10 703 3407

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)