Fasciectomy vs Collagenase Injection in Recurrent Dupuytren Disease

Surgical Fasciectomy Versus Collagenase Injection in Treating Recurrent Dupuytren Disease: a Randomized Controlled Trial

Patrocinadores

Patrocinador principal: Region Skane

Fuente Region Skane
Resumen breve

This randomized controlled trial will compare the outcome of surgery (fasciectomy) with that of local injection of Collagenase Clostridium Histolyticum in patients with recurrent finger joint contracture after previous treatment with either surgery or collagenase injection. Half of the participants will be treated with surgery while the other half will receive collagenase injection.

Descripción detallada

No definitive cure for Dupuytren disease (DD) currently exists and recurrence of finger contractures after treatment is common. Surgical fasciectomy is considered the standard treatment method for patients with recurrence. However, the procedure is associated with a high incidence of complications. Injection of Collagenase Clostridium Histolyticum into Dypuytren cords causing the contracture is a non-surgical treatment for DD and has been shown to be a safe and effective method. Most studies regarding collagenase injection have involved first-time treatment. Efficacy of collagenase injection in patients with recurrent DD, beyond the immediate effect, has not yet been determined. This randomized trial will compare the outcome of surgical fasciectomy and collagenase injection in treating patients with finger joints contracture due to recurrent DD. The study is a single-center randomized controlled trial. Patients referred to an orthopedic department are screened for eligibility. The inclusion criteria are recurrence of DD in one or more fingers after previous treatment with fasciectomy or collagenase injection, a passive extension deficit ≥30 degrees in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint in a previously treated finger, and a palpable cord believed to cause the recurrent contracture. A total of 56 patients will be randomized (computer-generated randomization list, stratified according to type of previous treatment and affected finger), to either surgical fasciectomy or collagenase injection. A blinded hand therapist will measure range of motion (including active and passive extension deficit) at baseline and 3 months, 12 months, 24 months and 60 months after treatment. The primary outcomes are the total active extension deficit (MCP plus PIP) at 3 months and the proportion of patients with contracture worsening ≥20 degrees in the treated finger joint at 2 years compared to 3 months. The secondary outcomes include total passive extension deficit, the 11-item disabilities of the arm, shoulder and hand (QuickDASH) score, EuroQol 5-dimensions (EQ-5D) index, cold intolerance symptom severity score, palmar pain score, pain visual analog scale (VAS) score, satisfaction VAS score, adverse events and costs.

Estado general Enrolling by invitation
Fecha de inicio March 20, 2018
Fecha de Terminación May 31, 2024
Fecha de finalización primaria May 31, 2021
Fase Phase 4
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints) Change from baseline to 3 months
Proportion of patients with worsening in total active extension deficit ≥20 degrees 24 months compared to 3 months
Resultado secundario
Medida Periodo de tiempo
11-item disabilities of the arm, shoulder and hand (QuickDASH) score Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
EuroQoL 5-dimensions (EQ-5D) Index Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
Pain score Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
Satisfaction score 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
Adverse events Anytime during 24 months after treatment
Costs From baseline through 24 months
Total active motion Change from baseline to 3 months, 12 months, 24 months and 60 months
Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints) Change from baseline to 12 months, 24 months and 60 months
Proportion of patients with worsening in total active extension deficit ≥20 degrees 60 months compared to 3 months
Palmar pain score Change over time from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months.
Cold intolerance symptom severity score Change from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months.
Total passive extension deficit (metacarpophalangeal plus proximal interphalangeal joints) Change from baseline to 24 months and 60 months
Inscripción 56
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: Fasciectomy

Descripción: Surgical excision of Dupuytren cords causing finger joint contractures. Surgery done under regional or general anesthesia. Additional procedures (such as capsulotomy or skin graft) done if surgeon deemed necessary.

Etiqueta de grupo de brazo: Surgical fasciectomy

Otro nombre: Surgery

Tipo de intervención: Drug

Nombre de intervención: Collagenase Clostridium Histolyticum

Descripción: Injection of Collagenase into the Dupuytren cord after local anesthesia (nerve block) followed 24-48 hours later by finger manipulation after local anesthesia

Etiqueta de grupo de brazo: Collagenase Clostridium Histolyticum

Otro nombre: Non-surgical treatment

Elegibilidad

Criterios:

Inclusion Criteria:

- Seeking treatment for recurrence of Dupuytren´s contracture in at least one finger.

- Passive extension deficit of 30 degrees or greater in the metacarpophalangeal and/or proximal interphalangeal joint in a finger previously treated with surgical fasciectomy or collagenase injections.

- Palpable cord in the palm and/or affected finger causing the recurrent contracture.

- No surgery or collagenase in the finger with recurrent contracture in the past 12 months.

Exclusion Criteria:

- Medical comorbidities that constitute a contraindication for surgical fasciectomy or collagenase injection.

- Signs of nerve or vascular injury in the affected finger.

- Osteoarthritis in the metacarpophalangeal and/or proximal interphalangeal joint joint in the affected finger

- Complications after the previous treatment, such as infection or complex regional pain syndrome (CRPS).

- Previous trauma or other surgery involving the affected finger.

- More than 2 previous surgeries or collagenase treatments in the affected finger.

- Previous treatment with both fasciectomy and collagenase in the affected finger.

- Examining surgeon deems further fasciectomy inappropriate or potentially associated with very high complication risk, for example in severe contracture and/or severe scarring after the previous surgeries and considers salvage procedures (such as amputation) as the more appropriate treatment.

- Patient refusal to participate

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Isam Atroshi, MD, PhD Principal Investigator Lund University
Ubicación
Instalaciones: Department of Orthopedics Hässleholm-Kristianstad
Ubicacion Paises

Sweden

Fecha de verificación

September 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Region Skane

Nombre completo del investigador: Isam Atroshi

Título del investigador: Professor

Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Surgical fasciectomy

Tipo: Active Comparator

Descripción: Fasciectomy according to usual care (surgery), implying excision of Dupuytren's cords and tissues to release the finger joint contractures

Etiqueta: Collagenase Clostridium Histolyticum

Tipo: Experimental

Descripción: Injection of 0.8 mg collagenase clostridium histolyticum into multiple spots in the Dupuytren cords followed by finger manipulation 1-2 days later to release the finger joint contractures

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: Randomized parallel Group, ratio 1:1.

Propósito primario: Treatment

Enmascaramiento: Single (Outcomes Assessor)

Descripción de enmascaramiento: Before examination the patients will wear thin gloves in the treated hands to conceal possible surgical scars so the examiner will be blinded to the group allocation.

Fuente: ClinicalTrials.gov