RESUMEN
BACKGROUND: Vascular adverse events after collagenase injection for Dupuytren disease are absent in large trials and systematic reviews. The aim of this study is to present a case series of delayed vascular complications after collagenase treatment. METHODS: A prospective evaluation of 1181 consecutively treated patients at one orthopedic department identified three patients reporting symptoms of possible vascular complication. Baseline demographics and description of symptoms were collected, with a physical examination documenting extension deficit and neurovascular status. All patients completed the Cold Intolerance Symptom Severity (CISS) scale (range 4-100, lower is better) and underwent Doppler sonography examination of the digital arteries. RESULTS: All patients were treated in the small finger and two had an isolated proximal interphalangeal joint contracture. All patients had a delayed presentation of a few months, with episodes of white discoloration of the treated finger relieved within 30 min and associated with variable pain, paresthesia, stiffness and weakness. Two of the patients reported cold exposure as an episode trigger and had a pathological CISS score (40 and 36, respectively). Doppler sonography identified a nonpatent ulnar digital artery in one patient. CONCLUSIONS: Delayed vascular complication after collagenase treatment is rare, but surgeons and patients should be aware of the risk, especially when treating the small finger.
Asunto(s)
Contractura de Dupuytren , Humanos , Contractura de Dupuytren/diagnóstico por imagen , Contractura de Dupuytren/tratamiento farmacológico , Contractura de Dupuytren/cirugía , Colagenasa Microbiana/efectos adversos , Resultado del Tratamiento , Colagenasas/efectos adversos , InyeccionesRESUMEN
PURPOSE: To compare collagenase injection with surgical fasciectomy in Dupuytren disease (DD) for the prevalence of contracture in treated fingers 5 years after treatment. METHODS: This was a single-center, comparative cohort study comprising 2 cohorts of patients treated for DD in 1 or more of 3 ulnar fingers with collagenase injection (159 patients) or surgical fasciectomy (59 patients). At 5 years after treatment, 13 collagenase-treated and 8 fasciectomy-treated patients had undergone subsequent treatment on the treated fingers and were considered to have current contracture. Of the remaining patients, 112 collagenase-treated patients (128 hands, 180 fingers) and 46 fasciectomy-treated patients (49 hands, 63 fingers) attended follow-up evaluation performed by 2 independent examiners (participation rate 84% and 93%, respectively). We defined current contracture in a treated finger as an active extension deficit of ≥20° in the metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joint or a total (MCP + PIP) active extension deficit (TAED) of ≥30°. We used linear mixed models to analyze differences between the cohorts over time. RESULTS: In the collagenase cohort, current contracture was present in 45 (25%) MCP and 60 (33%) PIP joints, and in the fasciectomy cohort, current contracture was present in 12 MCP (19%) and 30 PIP (48%) joints; a TAED of ≥30° was present in 79 (44%) of the collagenase-treated and 30 (48%) of the fasciectomy-treated fingers. In MCP and PIP joints with ≥20° pretreatment contracture, complete correction was observed in 82 (56%) MCP and 30 (30%) PIP joints in the collagenase cohort and 23 (70%) MCP and 5 (16%) PIP joints in the fasciectomy cohort. There was no statistically significant difference between the 2 cohorts in the TAED change over time. CONCLUSIONS: In patients with DD, collagenase injection and surgical fasciectomy improved finger joint contracture over the pretreatment status but had a high prevalence of joint contracture in the treated fingers 5 years after treatment. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.
Asunto(s)
Contractura de Dupuytren , Luxaciones Articulares , Estudios de Cohortes , Colagenasas/uso terapéutico , Contractura de Dupuytren/tratamiento farmacológico , Contractura de Dupuytren/cirugía , Fasciotomía , Articulaciones de los Dedos/cirugía , Humanos , Colagenasa Microbiana/uso terapéutico , Resultado del TratamientoRESUMEN
Background and purpose - Few prospective studies have reported the long-term effect durability of collagenase injections for Dupuytren disease. We assessed the 3-year treatment outcome of collagenase injections and predictors of recurrence.Patients and methods - We conducted a single-center prospective cohort study. Indication for collagenase injection was palpable Dupuytren's cord and active extension deficit (AED) ≥ 20° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint. From November 2012 through June 2013, we treated 86 consecutive patients (92 hands, 126 fingers). A hand therapist measured joint contracture before, 5 weeks, and 3 years after injection. The patients rated their treatment satisfaction. Primary outcome was proportion of treated joints with ≥ 20° AED worsening between the 5-week and 3-year measurements. We analyzed predictors of recurrence.Results - 3-year outcomes were available for 83 of the 86 patients (89 hands, 120 treated fingers). Between the 5-week and 3-year measurements, AED worsened by ≥ 20° in 17 MCP (14%) and 28 PIP (23%) joints. At 3 years, complete correction (passive extension deficit 0-5°) was present in 73% of MCP and 35% of PIP joints. Treatment of small finger PIP joint contracture, greater pretreatment contracture severity, and previous fasciectomy on the treated finger were statistically significant predictors of recurrence. Treatment satisfaction was rated as very satisfied or satisfied in 59 of 87 hands. No long-term treatment-related adverse events were observed.Interpretation - 3 years after collagenase injections for Dupuytren disease, improvement was maintained and treatment satisfaction reported in two-thirds of the treated hands, with no adverse events. Complete contracture correction was achieved in 3 of 4 MCP joints, but in only a third of the PIP joints.
Asunto(s)
Clostridium histolyticum , Contractura de Dupuytren/tratamiento farmacológico , Colagenasa Microbiana/uso terapéutico , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Contractura de Dupuytren/fisiopatología , Femenino , Articulaciones de los Dedos/fisiopatología , Humanos , Inyecciones , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Rango del Movimiento Articular/fisiología , Recurrencia , Índice de Severidad de la EnfermedadRESUMEN
INTRODUCTION: There is no definitive cure for Dupuytren disease (DD), and recurrence of finger contractures after treatment is common. Surgical fasciectomy is considered the standard treatment method for recurrence, although associated with a high incidence of complications. Collagenase injection, a non-surgical treatment option, has been shown to be a safe and effective method; however, most studies regarding collagenase have involved first-time treatment. Collagenase efficacy in patients with recurrent DD beyond the immediate effect has not yet been determined. The aim of our study is to compare surgical fasciectomy and collagenase injection in treating recurrent DD. METHODS AND ANALYSIS: The study is a single-centre randomised controlled trial. Inclusion criteria are recurrence of DD in one or more fingers after previous treatment with fasciectomy or collagenase injection, a passive extension deficit ≥30° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint, and a palpable cord causing the recurrent contracture. A total of 56 patients will be randomised to either surgical fasciectomy or collagenase injection. A hand therapist blinded to patients' group allocation will measure range of motion at baseline, 3 months, 12 months, 24 months and 60 months. The primary outcomes are the total active extension deficit (MCP plus PIP) at 3 months and the proportion of patients with contracture worsening ≥20° in the treated finger joint at 2 years compared with 3 months. The secondary outcomes include changes in total active motion, active and passive extension deficit from baseline up to 5 years, scores on patient-reported outcome measures, adverse events and costs of treatment. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Regional Ethical Review Board, Lund University, Sweden(2017/623). The trial will be conducted according to the Helsinki Declaration of 1975, revised in 2000. The results of the trial will be disseminated as published articles in peer-reviewed journals. TRIAL REGISTRATION: NCT03406338; Pre-results.
Asunto(s)
Colagenasas/uso terapéutico , Contractura de Dupuytren/terapia , Fasciotomía , Adulto , Protocolos Clínicos , Colagenasas/administración & dosificación , Contractura de Dupuytren/tratamiento farmacológico , Contractura de Dupuytren/cirugía , Fasciotomía/métodos , Humanos , Inyecciones , RecurrenciaRESUMEN
BACKGROUND: The most commonly reported outcome measure in Dupuytren disease is the extension deficit in finger joints. This study aimed to investigate the examiners' influence on the measured difference between active and passive extension deficit. METHODS: A prospective cohort study was conducted on 157 consecutive patients (81% men, mean age 70 years) scheduled for collagenase treatment for Dupuytren disease. Before injection, one of three experienced hand therapists measured active extension deficit (AED) and passive extension deficit (PED) in the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints of the affected fingers using a hand-held metal goniometer. We included joints with ≥10° AED, and calculated mean AED and PED in MCP and PIP joints measured by each examiner. For adjusted analysis we used a mixed effects model to determine the relationship between the examiner and the AED-PED difference. RESULTS: For all 291 joints measured, mean AED was 46° (SD 21) and mean PED was 37° (SD 23). Mean difference between AED and PED measured by examiner 1 was 6° (SD 6), by examiner 2 was 9° (SD 9), and by examiner 3 was 12° (SD 9). The mixed effects model analysis showed that the identity of the examining therapist was a significant determinant of the AED-PED difference. CONCLUSIONS: In Dupuytren disease measurement of active and passive extension deficit in finger joint contractures may vary significantly between different examiners. This must be taken into consideration when designing clinical studies and comparing outcomes between studies.
Asunto(s)
Contractura de Dupuytren/fisiopatología , Articulaciones de los Dedos/fisiopatología , Articulación Metacarpofalángica/fisiopatología , Relaciones Médico-Paciente , Anciano , Anciano de 80 o más Años , Colagenasas/administración & dosificación , Contractura de Dupuytren/tratamiento farmacológico , Femenino , Articulaciones de los Dedos/efectos de los fármacos , Humanos , Masculino , Articulación Metacarpofalángica/efectos de los fármacos , Persona de Mediana Edad , Estudios Prospectivos , Rango del Movimiento Articular/efectos de los fármacos , Rango del Movimiento Articular/fisiología , Resultado del TratamientoRESUMEN
Collagenase injection for Dupuytren's contracture is commonly administered without anesthesia. The authors studied the benefit of injecting local anesthesia before collagenase in reducing treatment-related pain. This prospective cohort study included 187 patients (mean age, 69 years; 80 percent men) at two orthopedic departments in Sweden. At one center, 161 consecutive patients scheduled for collagenase injection were assigned to two groups by alternating outpatient clinics; 78 received collagenase without local anesthesia using a modified method (injecting 0.80 mg in multiple spots in the cord) and 83 received local anesthesia injected in the proximal palm before collagenase. At the other center, 26 consecutive patients received collagenase using the standard method (0.58 mg injected in one spot) without local anesthesia. Immediately after the first injection (collagenase or local anesthesia), the patients rated the severity of injection-related pain on a visual analogue scale from 0 (no pain) to 10 (worst pain). Before finger manipulation 1 or 2 days after injection, the patients rated the pain experienced since injection. Mean score ± SD for pain experienced during modified collagenase injection was 4.3 ± 2.5 without local anesthesia and 2.3 ± 1.7 during injection of local anesthesia (before collagenase) (age- and sex-adjusted mean difference, 2.1; 95 percent CI, 1.5 to 2.7; p < 0.001). Mean pain score ± SD during standard collagenase injection without local anesthesia was 4.8 ± 1.8. Mean pain score ± SD during the injection-manipulation interval was 2.9 ± 1.9 in the group without local anesthesia and 2.9 ± 2.3 in the local anesthesia group (p = 0.79). This study shows that local anesthesia significantly reduces the patient's overall pain experience during collagenase treatment for Dupuytren's contracture. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.
Asunto(s)
Anestesia Local/métodos , Anestésicos Locales/administración & dosificación , Colagenasas/administración & dosificación , Contractura de Dupuytren/terapia , Inyecciones Intralesiones/efectos adversos , Dolor/tratamiento farmacológico , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dolor/etiología , Estudios ProspectivosRESUMEN
BACKGROUND AND PURPOSE: Treatment of Dupuytren's contracture (DC) with collagenase Clostridium histolyticum (CCH) consists of injection followed by finger manipulation. We used a modified method, injecting a higher dose than recommended on the label into several parts of the cord, which allows treatment of multiple joint contractures in 1 session and may increase efficacy. We studied the occurrence of skin tears and short-term outcome with this procedure. PATIENTS AND METHODS: We studied 164 consecutive hands with DC, palpable cord, and extension deficit of ≥ 20º in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint (mean patient age 70 years, 82% men). A hand surgeon injected all the content of 1 CCH vial (approximately 0.80 mg) into multiple spots in the cord and performed finger extension under local anesthesia after 1 or 2 days. A nurse recorded skin tears on a diagram and conducted a standard telephone follow-up within 4 weeks. A hand therapist measured joint contracture before injection and at a median of 23 (IQR: 7-34) days after finger extension. RESULTS: A skin tear occurred in 66 hands (40%). The largest diameter of the tear was ≤ 5 mm in 30 hands and > 10 mm in 14 hands. Hands with skin tear had greater mean pretreatment MCP extension deficit than those without tear: 59º (SD 26) as opposed to 32º (SD 23). Skin tear occurred in 21 of 24 hands with MCP contracture of ≥ 75º. All tears healed with open-wound treatment. No infections occurred. Mean improvement in total (MCP + PIP) extension deficit was 55º (SD 28). INTERPRETATION: Skin tears occurred in 40% of hands treated with collagenase injections, but only a fifth of them were larger than 1 cm. Tears were more likely in hands with severe MCP joint contracture. All tears healed without complications. Short-term contracture reduction was good.