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Orthopaedics & Traumatology: Surgery & Research
Sous presse. Epreuves corrigées par l'auteur. Disponible en ligne depuis le samedi 25 août 2018
Doi : 10.1016/j.otsr.2018.05.012
Received : 10 November 2017 ;  accepted : 16 May 2018
Adverse effects associated with collagenase clostridium histolyticum in Dupuytren disease: A prospective study
 

Rafael Sanjuan-Cerveró a, b, , Francisco J Carrera-Hueso c, Pedro Vazquez-Ferreiro b, d
a Orthopedics and Traumatology Surgery, Hospital de Denia, Partida Beniadlà, S/N, Denia, 03700 Alicante, Spain 
b University of Granada, Spain 
c Pharmacy Service, Hospital Dr Moliner, Porta Coeli s/n Serra, 46118 Valencia, Spain 
d Ophtalmologic Department, Hospital Virxen da Xunqueira, Cee, 15270 A Coruña, Spain 

Corresponding author. C/del Vall 42, 1°, 1a Cullera, 46400 Valencia, Spain.C/dem Vall 42, 1°, 1a CulleraValencia46400Spain
Highlights

The efficacy of CCH is achieved in most cases, more frequently in cases of mild severity. In one month evolution only indicates the correct administration of the drug.
The occurrence of adverse effects in higher according to contracture severity, proximal-interphalangeal joints contractures and fifth finger.
The association between number of adverse effects and treatment effectiveness is inconclusive.

The full text of this article is available in PDF format.
Abstract
Background

Collagenase clostridium histolyticum is now recognized as a viable treatment for Dupuytren disease. The high rate of adverse effects reported in patients continues to spark debate and raise questions about the true frequency of effects and their associated mechanisms of action.

Hypothesis

To investigate whether outcomes of CCH treatment are related to the number of adverse effects experienced. To evaluate short-term clinical outcomes in a series of patients.

Material and methods

Prospective single-center cohort study. The Primary End Point for effectiveness at 30 days was deficit of 0°–5°. Adverse effects were evaluated during CCH injection, removal of the dressing prior to finger extension, and finger extension. To investigate the relationship between adverse effects and treatment effectiveness, we analyzed the association between number of effects and clinical outcome at 30 days.

Results

A total of 208 injections were evaluated. The mean baseline contracture was 32.11°. Ninety-four patients (45.2%) had a mild contracture. Treatment was effective at 30 days in 194 of the injections (93.3%). The rate of effectiveness per joint was 93.5% for metacarpophalangeal joints (n =129) and 92.9% for proximal-interphalangeal joints (n =65). In total, 734 adverse effects were reported (mean, 3.53). No statistically significant associations were identified between disease severity and secondary effects. Variance analysis showed statistically significant differences in patients with severe contractures (mean, 3.91; 95% CI 3.57–4.25), and in patients with proximal-interphalangeal contractures (mean, 4.17; 95% CI 3.76–4.59).

Conclusions

We found no relationship between number of adverse effects and treatment effectiveness at one month following CCH injection.

Level of proof

IV, cohort prospective study.

The full text of this article is available in PDF format.

Keywords : Collagenase clostridium histolitycum, Dupuytren disease, Drug safety, Complication, Effectiveness




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