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.

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. - RCT comparing two surgical techniques for secondary Dupuytren contracture

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34920

Enrollment

Registered

2010-01-20

Start date

2010-01-26

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

hand diseases Secondary Dupuytren's contracture

Interventions

Anti-coagulants should be stopped before the surgical procedures. 1) Limited fasciectomy and limited dermofasciectomy - Commonly used technique the participating clinic - Use of tourniquet - Limited

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -males and females - patients of 18 years and older - secondary Dupuytren's contracture - PIP > 30 degrees / MCP > 20 degrees - one or more affected rays - severe or less severe diatheses - ASA criteria I, II, and III

Exclusion criteria

Exclusion criteria: - Primary Dupuytren*s contracture - Amputation of 1 or more fingers of the affected hand. - More than 2 times hand surgery in the affected ray. - disorder (trauma/congenital) in the past that affects the affected finger (0-situation is unknown). - Dystrophic characteristics in the past. - use of anticoagulants that can not be stopped for surgery - ASA IV and V

Design outcomes

Primary

Measure	Time frame
- Convalescence: return to function and return to work - VAS score: standardized list of questions about pain and well-being of the patient; to register the pain of the hand and donor site. - Contracture reductions: 1) Total passive extension deficity (TPED): the sum of the passive extension deficits of the metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints. 2) Boyes measure: measuring the distance from pulp to distal palmar crease with the hand in a maximum fist position. Flexion is defined as reduced if the distance is more than 1.5 cm.	—

Measure

Time frame

- Convalescence: return to function and return to work - VAS score: standardized list of questions about pain and well-being of the patient; to register the pain of the hand and donor site. - Contracture reductions: 1) Total passive extension deficity (TPED): the sum of the passive extension deficits of the metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints. 2) Boyes measure: measuring the distance from pulp to distal palmar crease with the hand in a maximum fist position. Flexion is defined as reduced if the distance is more than 1.5 cm.

—

Secondary

Measure	Time frame
Intervention: o Register the anaesthetics drugs administered and vital signs during surgery. o Register of arthrolysis (if it is used) Hand sensibility and complications due to intervention: o Semmes Weinstein testo Swelling measured following hand volume o DASH score: standardized list of questions about hand and arm function of the patient o CISS-score: cold-intollerance o Esthetic and contracture correction: Kodak photos o EQ-5D: cost-effectiveness o MRI: fat monitoring o cord: investigate the new intervention technique Patients satisfaction: o To determine the patient satisfaction, a questionaire with VAS-scale was made.	—

Measure

Time frame

Intervention: o Register the anaesthetics drugs administered and vital signs during surgery. o Register of arthrolysis (if it is used) Hand sensibility and complications due to intervention: o Semmes Weinstein testo Swelling measured following hand volume o DASH score: standardized list of questions about hand and arm function of the patient o CISS-score: cold-intollerance o Esthetic and contracture correction: Kodak photos o EQ-5D: cost-effectiveness o MRI: fat monitoring o cord: investigate the new intervention technique Patients satisfaction: o To determine the patient satisfaction, a questionaire with VAS-scale was made.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)