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

A pilot randomized controlled trial comparing the effect of a percutaneous and lipofilling technique in patients with a primary Dupuytren*s contracture with standard fasciectomy surgery on convalescence, contracture correction and recurrence rate. - RCT comparing two surgical techniques for Dupuytren's contracture

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31898

Enrollment

Registered

2008-11-27

Start date

2009-02-24

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

Dupuytren's contracture hand diseases

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 - all ages - primary Dupuytren*s contracture - PIP > 30º/ MCP > 20º - one or more affected rays - severe or less severe diatheses - American society of Anaesthesiologists (ASA) criteria I, II and III

Exclusion criteria

Exclusion criteria: - recurrent Dupuytren*s contracture - history of hand surgery on the affected finger(s) - use of blood thinners 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 test o Swelling measured following hand volume o DASH score: standardized list of questions about hand and arm function of the patient Patients satisfaction: o To determine the patient satisfaction, the patients are asked to fill in five questions (on a VAS scale) at 6 months and 1 year post-operatively: - Are you satisfied with the undertaken operation and treatment? - Are you satisfied with the gain of hand function? - Are you satisfied with the recovery time that was needed to regain full hand function again? - If the choice presented itself again, would you consider this form of surgery? - Would you recommend this kind of surgery to a friend or family?	—

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 test o Swelling measured following hand volume o DASH score: standardized list of questions about hand and arm function of the patient Patients satisfaction: o To determine the patient satisfaction, the patients are asked to fill in five questions (on a VAS scale) at 6 months and 1 year post-operatively: - Are you satisfied with the undertaken operation and treatment? - Are you satisfied with the gain of hand function? - Are you satisfied with the recovery time that was needed to regain full hand function again? - If the choice presented itself again, would you consider this form of surgery? - Would you recommend this kind of surgery to a friend or family?

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)