Collagenase injections for Dupuytren's disease: prospective cohort study assessing 2-year treatment effect durability

Abstract

ObjectivesTo assess 2-year durability of joint contracture correction following collagenase injections for Dupuytren's disease.DesignProspective cohort study.SettingOrthopaedic Department in Sweden.ParticipantsPatients with palpable Dupuytren's cord and active extension deficit (AED) ≥30° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint. A surgeon injected 0.80 mg collagenase into multiple cord parts and performed finger manipulation under local anaesthesia after 24–48 hours. A hand therapist measured joint contracture before and 5 weeks after injection in all treated patients. Of 57 consecutive patients (59 hands), 48 patients (50 hands) were examined by a hand therapist 24–35 months (mean 26) after injection. Five of the patients had received a second injection in the same finger within 6 months of the first injection.Outcome measuresPrimary outcome was proportion of treated joints with ≥20° worsening in AED from 5 weeks to 2 years.ResultsBetween the 5-week and the 2-year measurements, AED had worsened by ≥20° in seven MCP and seven PIP joints (28% of the treated hands; all had received a single injection). Mean AED for the MCP joints was 54° before injection, 6° at 5 weeks and 9° at 2 years and for the PIP joints 30°, 13° and 16°, respectively. For joints with ≥10° contracture at baseline, mean (95 % CI) baseline to 2 years AED improvement was for MCP 49° (41–54) and for PIP 25° (17–32). No treatment-related adverse events were observed at the 2-year follow-up evaluation.ConclusionsTwo years after collagenase injections for Dupuytren's disease, improvement was maintained in 72% of the treated hands. Complete contracture correction was seen in more than 80% of the MCP but in less than half of the PIP joints.

Efficacy of Collagenase Clostridium Histolyticum for Dupuytren Disease: A Systematic Review

“…The fact that a greater number of patients have reached the primary end point in studies lasting more than 1 year is due, in part, to the fact that many of these studies have been funded by or related to the company that markets the drug, which is why the patient selection criteria, the surgeon's experience or the protocol for patient maintenance, minimizing the losses of individuals with a positive result, may be regarded as biased. 9,34,35,37,48,54,60 With regard to joint treatment, the demonstrated results concur with many of the series published. The outcome for the MCP joint is better than the outcome for the PIP, and the recurrences of the latter are also much more frequent.…”

“…The measurement of results has mixed values at varying degrees of measuring: a priori 16 articles used the range of movement (ROM) to evaluate results in whole or in part, while the remaining 35 did not use this method, limiting themselves to assessing extension deficit results in degrees by separate joints, groups of joints (passive extension deficit [PED]), or one article even 44 The administered dose was standard in all studies, except for two studies that used double dose on the same hand at a time, 17,46 and four that used the standard dose plus the amount remaining in the vial in various formats. 39,[47][48][49] Twenty-three studies followed an injection protocol in which they allowed one to three infiltrations per joint and patient, four 25,29,38,47 studies used one or two injections, even though they followed the CORD protocols, and presumably if it were needed, they would have used three, and the rest used a protocol of one injection for an infiltration of a joint. In the studies that specified how many vials were used per joint, the mean was 1.23 (range 0.8-1.6; SD: 0.36), with only one study having used less than one vial per joint, 50 and with the studies by Gilpin 14 (1.5) and Sood 30 (1.6) being the ones that used more than one vial per joint.…”

“…40 The systematic implementation of a physiotherapy protocol after CCH treatment is another controversial point regarding the outcomes. Thirteen articles indicate that patients were systematically referred to an established physiotherapy protocol or that monitoring was performed by specialist physiotherapists, 20,25,29,32,34,35,40,41,44,48,[51][52][53] four specify that patients did not receive physical therapy, 6,22,49,54 two have indicated it only if necessary, 46,55 and the rest did not indicate whether or not a physiotherapy protocol was included in the treatment protocol.…”

“…56 The bibliography is variable in this regard. Twenty-seven articles refer to the systematic use of this device, 6,14,15,17,20,22,25,26,30,33,35,36,[38][39][40][41]44,[46][47][48][49]51,54,[57][58][59][60] and a multicenter study reports that only one of the centers used it without performing a statistical analysis of what this measurement could indicate. 61…”

“…Apart from the CORDLESS studies, 9,10 few studies have collected the incidence of recurrences in their results. 19,30,34,35,37,48,58 The rate of recurrence during the follow-up period ranged from 1.7% in 1 year 37 to 59% in the series by Sood 30 within the same period, but with its own criteria of recurrence. Upon eliminating these two values, this rate ranged between 7-28%.…”