The CeCORD-J study on collagenase injection versus aponeurectomy for Dupuytren's contracture compared by hand function and cost effectiveness

Abstract

This study compared hand function and the cost-effectiveness of treatment between collagenase Clostridium histolyticum (CCH) injection and limited fasciectomy for patients with Dupuytren’s contracture (DC). The CeCORD-J study is a prospective, multicenter, non-randomized controlled, observational study of two parallel groups. Participants were DC patients with multiple affected fingers, including flexion contracture of the proximal interphalangeal (PIP) joint. The primary outcome was the Hand10 score, as a patient-reported outcome measure (PROM). We set secondary outcomes of EQ-5D-5L (QOL) score, degree of extension deficit, and direct cost. Propensity score adjustment was used to balance differences in patient characteristics between groups. Participants comprised 52 patients in the Collagenase group and 26 patients in the Surgery group. There were no significant differences in the Hand10 and QOL scores between the two groups at 26 weeks. Mean direct cost was 248,000 yen higher in the Surgery group than in the Collagenase group. Extension deficit angle of the PIP joint was significantly larger in the Collagenase group at 26 weeks. Although the Collagenase group showed dominance in cost-effectiveness, there was no significant difference between the two groups in hand function at 26 weeks.

Industry Sponsorship Bias in Collagenase Clinical Trials for Dupuytren Disease

“…Range of motion was not specifically reported in trials by Zhou et al, Alberton et al, Sanjuan-Cervero et al, Yamamoto et al, and Skov et al and so had to be calculated by the authors. 9,15,20,22,23 The authors also had to make estimations based off of graphs in Warwick et al allowing for error in visual interpretation. 16 Additionally, these calculations did not provide confidence intervals in order for any significant difference to be determined between groups; therefore, this portion of our hypothesis to determine difference between sponsorship could not be determined.…”

“…The ROM values could be underestimated if full flexion had also increased after treatment; however, flexion is rarely affected by DD with extension being the main detriment from the disease process. Range of motion was not specifically reported in trials by Zhou et al, Alberton et al, Sanjuan-Cervero et al, Yamamoto et al, and Skov et al and so had to be calculated by the authors 9,15,20,22,23 . The authors also had to make estimations based off of graphs in Warwick et al allowing for error in visual interpretation 16 .…”

Comparing Complications and Patient Satisfaction Following Injectable Collagenase Versus Limited Fasciectomy for Dupuytren’s Disease: A Systematic Review and Meta-Analysis

“…Of these 14 studies [ 26 - 39 ], six pertained to CCH injection [ 26 , 35 - 39 ], two to LF [ 33 , 34 ], and six directly compared these two treatment modalities [ 27 - 32 ], as summarized in Table 1 .…”

“…The two LF studies comprised both an RCT [ 34 ] and prospective cohort studies [ 33 ]. Half of the comparative studies were retrospective reviews [ 28 - 29 , 32 ], with the remaining being prospective in nature [ 27 , 30 , 31 ]. Essential details, such as the number of patients, mean patient ages, gender, and follow-up durations, were consistently reported across all studies.…”

“…For the comparative studies [ 27 - 32 ], the total number of joints considered was 812, involving 365 patients. Of these, five studies [ 27 - 31 ] provided information on complications, totaling 728 treated joints in 319 patients, with 135 patients undergoing LF and 184 receiving CCH injections.…”