Behandlung der Dupuytren’schen Kontraktur mit Kollagenase – Ein-Jahres-Follow-up-Analyse anhand von 37 Patienten

Binter, A.; Neuwirth, Maximilian; Rab, Matthias

doi:10.1055/s-0034-1395604

Cited by 8 publications

(5 citation statements)

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“…85% of the patients in the same study had a significant improvement of the contracture of at least 50%. The CORD II study as well as further clinical studies confirmed the efficacy and safety of this investigational treatment option [13–19, 4, 20–22].…”

Section: Introductionmentioning

confidence: 75%

Prospective observation of Clostridium histolyticum collagenase for the treatment of Dupuytren’s disease in 788 patients: the Austrian register

Arora

Angermann

Paul

et al. 2019

Arch Orthop Trauma Surg

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Introduction Since March 2011, the microbial collagenase of Clostridium histolyticum ( Xiapex®, Swedish Orphan Biovitrum AB, Stockholm, Sweden) has become available in the European Union for treatment of Dupuytren’s disease. The purpose of this study was to evaluate potential safety risks of Xiapex® and to contribute to a better understanding for its use. Methods A prospective, non-interventional, observational study using Xiapex® for Dupuytren’s disease named XIANIS was conducted between 1.10.2011 and 01.10.2017. Treatment was conducted in accordance to the manufacturer information. Patients were invited for follow-up after 1 week, 1 month, 3 months and 1 year. Demographic data, treatment data, pain levels, anaesthetic application during passive manipulation, subjective function improvement, subjective satisfaction and adverse events were recorded. Results 788 patients with 814 treatments were included who suffered from Dupuytren’s contracture for a mean of 64 months. The metacarpophalangeal joint was affected in 57% of cases and the PIP joint in 40.8% with a mean contracture of 39° and 56°, respectively. A change in the contracture down to 0°–5° was reported in 66.5% of cases, while 25.5% achieved a partial improvement. The pain during the injection was rated 4.5 and 3.3 during passive manipulation. Adverse events were reported in the majority of treated patients with skin tears being one main common event (26%). Further adverse outcomes were bleeding/hematoma, joint swelling, injection-site swelling, pressure sensitivity, erythema, injection-site pain, peripheral edema, blood blisters, blisters, painless lymphadenopathy, painful lymphadenopathy, axillary pain, arthralgia and sensory abnormality. There were no reported tendon ruptures, anaphylactic reactions or ligament injuries. On 1-year follow-up, 29% showed an increased contracture of a mean of 24° with the need for surgical treatment in 2% of patients. 74% of patients were very satisfied and 72% showed a high functional improvement. Conclusion The injectable collagenase Clostridium histolyticum (Xiapex®) proved to be effective and safe in patients with Dupuytren’s disease. Minor adverse events disappeared within 30 days and the need for surgical treatment within 1 year was very low (2%). No major complications or rare side effects were seen in this prospective observational study.

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Section: Introductionmentioning

confidence: 75%

Prospective observation of Clostridium histolyticum collagenase for the treatment of Dupuytren’s disease in 788 patients: the Austrian register

Arora

Angermann

Paul

et al. 2019

Arch Orthop Trauma Surg

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“…During the past several years, studies with short-term (< 3 months)141516171819) or 1-year7891020) results have reported promising FFC resolution after CCH injection. Longer-term studies have also shown similar resolution rates and contracture improvement but showed mixed results with recurrence.…”

Section: Discussionmentioning

confidence: 99%

“…The purpose of this study was to examine the rates of contracture resolution and recurrence in patients who underwent enzymatic fasciotomy consisting of CCH injection, manipulation, splinting, and home-based therapy for treatment of Dupuytren contracture involving the metacarpophalangeal (MCP) or PIP joint. Given the successful maintenance of contracture resolution described by multiple studies at 1 year78910) and the tendency for recurrence during longer follow-up periods,111213) we hypothesized that contracture resolution would be maintained at 1 year but would tend to return by 2 years after CCH injection.…”

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confidence: 99%

Collagenase Clostridium Histolyticum Injection for Dupuytren Contracture: 2-Year Follow-up

2019

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Background Dupuytren disease is characterized by the development of palmar fibrous tissue that can lead to fixed flexion contracture (FFC) and contribute to functional loss of the involved digits. Our goal was to investigate rates of contracture resolution and recurrence in patients who underwent enzymatic fasciotomy for Dupuytren contracture consisting of collagenase clostridium histolyticum (CCH) injection followed by passive manipulation combined with splinting and home-based therapy. Methods We prospectively enrolled 34 patients (44 metacarpophalangeal [MCP] and 33 proximal interphalangeal [PIP] joints) treated by one orthopaedic hand surgeon between November 2010 and November 2014. On day 1, CCH was injected into a palpable fibrous cord of the involved fingers. The next day, the finger was passively extended to its maximal corrective position. FFC was measured for each joint before injection and immediately after manipulation. Patients were instructed to wear an extension splint at night and perform stretching exercises at home and were re-evaluated at 6 weeks, 4 months, 1 year, and 2 years. Resolution was defined as improvement of contracture to ≤ 5° of neutral. Recurrence was defined as an increase in FCC of ≥ 20° after treatment. Results Immediate contracture resolution occurred in 42 of 44 MCP joints ( p < 0.001), improving from 50° to 1.5°, and in 14 of 33 PIP joints ( p = 0.182), improving from 44° to 16°. Four joints had recurrence within 6 weeks. Of the 48 joints with minimum 4-month follow-up (mean, 26 months), 12 had recurrence at 2-year follow-up (MCP, 6; PIP, 6). At 2-year follow-up, MCP and PIP contractures measured 17° and 35.5°, respectively. Older age and multiple digit involvement were associated with higher recurrence rates. Conclusions CCH offers a safe, nonoperative option to correct FCC in Dupuytren disease with greater success for MCP joints compared to PIP joints. There is a tendency of reoccurrence within 2 years of treatment. Further investigation is needed to determine optimal timing of repeat CCH injection to improve upon or extend the period of contracture resolution.

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“…Demnach lassen sich mit CCH die Kontrakturen signifikant reduzieren und die Beweglichkeit der betroffenen Gelenke verbessern [1]. Die Rezidivrate erwies sich in einer 3-jahresanalyse als vergleichbar mit jener bei chirurgischer Standardbehandlung [2], und bei meist nur einmal erforderlicher Injektion ist die Behandlungsmethode effektiv und sicher [3][4][5]. Wir wenden in unserer Abteilung seit 2011 CCH an.…”

Section: Einleitung ▼unclassified

“…In einem Einjahres-Follup-up bei 37 Patienten mit 40 Fingergelenkskontrakturen kam es bislang zu einem Rezidiv. Die besten Behandlungsergebnisse waren bei Patienten mit isolierter Kontraktur des Metacarpophalangeal (MCP)-Gelenks erzielt worden, die Patientenzufriedenheit ist hoch [5]. Bei einer Prävalenz von 0,6 bis 31,6 % in den westlichen Industrieländern [6], der sich daraus ableitenden sozioökonomischen Bedeutung der Dupuytren-Kontraktur sowie des Kostendrucks im Gesundheitswesen sind außer der medizinischen Bewertung neuer Behandlungsmethoden im Vergleich zum Goldstandard auch ökonomische Betrachtungen sinnvoll und notwendig.…”

Section: Einleitung ▼unclassified

Kosteneffektivität der Behandlung von Patienten mit Dupuytren-Kontraktur mit mikrobieller Collagenase Clostridium histolyticum (Xiapex®) im Vergleich zur partiellen Fasziektomie in Österreich

Neuwirth

Binter

Pipam

et al. 2016

Handchir Mikrochir plast Chir

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Behandlung der Dupuytren’schen Kontraktur mit Kollagenase – Ein-Jahres-Follow-up-Analyse anhand von 37 Patienten

Abstract: The best results could be achieved in patients with isolated contractures of the MCP joint. Regarding the good functional results, the low complication rates and the high patient satisfaction, CCH represents a simple and effective treatment for Dupuytren's contracture in selected cases.

Cited by 8 publications

References 9 publications

Prospective observation of Clostridium histolyticum collagenase for the treatment of Dupuytren’s disease in 788 patients: the Austrian register

Prospective observation of Clostridium histolyticum collagenase for the treatment of Dupuytren’s disease in 788 patients: the Austrian register

Collagenase Clostridium Histolyticum Injection for Dupuytren Contracture: 2-Year Follow-up

Kosteneffektivität der Behandlung von Patienten mit Dupuytren-Kontraktur mit mikrobieller Collagenase Clostridium histolyticum (Xiapex®) im Vergleich zur partiellen Fasziektomie in Österreich

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