Does Use of a Night Extension Orthosis Improve Outcomes in Patients With Dupuytren Contracture Treated With Injectable Collagenase?

Nathan Lorris Bowers, Gregory Alan Merrell, Todd Foster, F Thomas D Kaplan, Nathan Lorris Bowers, Gregory Alan Merrell, Todd Foster, F Thomas D Kaplan

Abstract

Purpose: Current prescribing information for the treatment of patients with Dupuytren contracture with injectable collagenase Clostridium histolyticum (CCH) recommends use of a night extension orthosis for 4 months after treatment. The present study examines whether this treatment improves the outcomes.

Methods: Adult patients with Dupuytren contracture treated with CCH during the study period were eligible for inclusion. The patients were randomized to orthosis or no orthosis groups and were stratified based on the severity of contracture prior to randomization. The orthosis group was fitted postmanipulation with a hand-based custom orthosis that held the treated finger in maximal comfortable extension, and the patients were instructed to wear the orthosis at night for 3 months. The patients were assessed at 7-10 days, 30 days, and 90 days postmanipulation. Orthosis compliance was measured with a survey. The primary outcome measure was improvement in total active extension (TAE), defined as the sum of active metacarpophalangeal (MCP), proximal interphalangeal, and distal interphalangeal joint extension in the treated finger at 90 days after treatment. Secondary outcomes included total active flexion (TAF), Michigan Hand Questionnaire scores, patient satisfaction, and clinical success.

Results: Twenty-six patients completed the study, 12 in the orthosis group and 14 in the no orthosis group. The majority of contractures (90%) were primarily through the MCP joint. The patients in both the groups demonstrated significant improvements in TAE at 90-day follow-up (orthosis P = .002, no orthosis P = .001) . The difference in improvement in the median TAE between the 2 groups was not significant (P = .40). There were no significant differences between groups for TAE, TAF, Michigan Hand Questionnaire scores, patient satisfaction, or clinical success at any of the time points assessed (P > .05).

Conclusions: In patients with Dupuytren contracture with primarily MCP joint involvement, providing an orthosis after treatment with CCH may not offer a short-term benefit compared with CCH treatment alone in terms of TAE, TAF, or patient-reported outcome measures.

Type of study/level of evidence: Therapeutic I.

Keywords: Collagenase; Dupuytren; Orthosis fabrication.

© 2021 The Authors.

Figures

Figure 1
Figure 1
CONSORT 2010 flow diagram. Adult patients with Dupuytren contracture and a palpable cord treated with CCH by the primary investigator (28 patients) or his designee (1 patient) from February 2018 to January 2020 were screened for inclusion in the study.
Figure 2
Figure 2
Graph showing the median TAE in each group, with ranges from the 25th to the 75th percentile.

References

    1. Badalamente M.A., Hurst L.C., Hentz V.R. Collagen as a clinical target: nonoperative treatment of Dupuytren’s disease. J Hand Surg Am. 2002;27(5):788–798.
    1. Gilpin D., Coleman S., Hall S., Houston A., Karrasch J., Jones N. Injectable collagenase Clostridium histolyticum: a new nonsurgical treatment for Dupuytren’s disease. J Hand SurgAm. 2010;35(12):2027–2038.e1.
    1. Auxilium Pharmaceuticals Inc 2018.
    1. Hurst L.C., Badalamente M.A., Hentz V.R., et al. Injectable collagenase clostridium histolyticum for Dupuytren’s contracture. N Engl J Med. 2009;361(10):968–979.
    1. Peimer C.A., Blazar P., Coleman S., et al. Dupuytren contracture recurrence following treatment with collagenase clostridium histolyticum (CORDLESS study): 3-year data. J Hand Surg Am. 2013;38(1):12–22.
    1. Peimer C.A., Blazar P., Coleman S., Kaplan F.T.D., Smith T., Lindau T. Dupuytren contracture recurrence following treatment with collagenase Clostridium histolyticum (CORDLESS [collagenase option for reduction of Dupuytren long-term evaluation of safety study]): 5-year data. J Hand Surg Am. 2015;40(8):1597–1605.
    1. Tam L., Chung Y.Y. Needle aponeurotomy for Dupuytren contracture: effectiveness of postoperative night extension splinting. Plast Surg (Oakv) 2016;24(1):23–26.
    1. Ebskov L.B., Boeckstyns M.E., Sørensen A.I., Søe-Nielsen N. Results after surgery for severe Dupuytren’s contracture: does a dynamic extension splint influence outcome? Scand J Plast Reconstr Surg Hand Surg. 2000;34(2):155–160.
    1. Glassey N. A study of the effect of night extension splintage on post fasciectomy Dupuytren’s patients. Br J Hand Ther. 2001;6(3):89–94.
    1. Rives K., Gelberman R., Smith B., Carney K. Severe contractures of the proximal interphalangeal joint in Dupuytren’s disease: results of a prospective trial of operative correction and dynamic extension splinting. J Hand Surg Am. 1992;17(6):1153–1159.
    1. Jerosch-Herold C., Shepstone L., Chojnowski A.J., Larson D., Barrett E., Vaughan S.P. Night-time splinting after fasciectomy or dermo-fasciectomy for Dupuytren’s contracture: a pragmatic, multi-centre, randomised controlled trial. BMC Musculoskelet Disord. 2011;12:136.
    1. Collis J., Collocott S., Hing W., Kelly E. The effect of night extension orthoses following surgical release of Dupuytren contracture: a single-center, randomized, controlled trial. J Hand Surg Am. 2013;38(7):1285–1294.e2.
    1. Kemler M.A., Houpt P., van der Horst C.M. A pilot study assessing the effectiveness of postoperative splinting after limited fasciectomy for Dupuytren’s disease. J Hand Surg Eur. 2012;37(8):733–737.
    1. Malafa M.M., Lehrman C., Criley J.W., Amirlak B. Collagenase Dupuytren contracture: achieving single treatment success with a hand therapist-based protocol. Plast Reconstr Surg Glob Open. 2016;4(2):e629.
    1. Badalamente M.A., Hurst L.C. Enzyme injection as nonsurgical treatment of Dupuytren’s disease. J Hand Surg Am. 2000;25(4):629–636.
    1. Badalamente M.A., Hurst L.C. Efficacy and safety of injectable mixed collagenase subtypes in the treatment of Dupuytren’s contracture. J Hand Surg Am. 2007;32(6):767–774.
    1. Kaplan F.T., Badalamente M.A., Hurst L.C., Merrell G.A., Pahk R. Delayed manipulation after collagenase clostridium histolyticum injection for Dupuytren contracture. Hand (N Y) 2015;10(3):578–582.
    1. Witthaut J., Jones G., Skrepnik N., Kushner H., Houston A., Lindau T.R. Efficacy and safety of collagenase clostridium histolyticum injection for Dupuytren contracture: short-term results from 2 open-label studies. J Hand Surg Am. 2013;38(1):2–11.
    1. Harris P.A., Taylor R., Thielke R., Payne J., Gonzalez N., Conde J.G. Research Electronic Data Capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–381.
    1. IBM Corp; 2016. IBM SPSS Statistics for Windows. Version 24.0.
    1. Cyr L.M., Ross R.G. How controlled stress affects healing tissues. J Hand Ther. 1998;11(2):125–130.
    1. Citron N., Hearnden A. Skin tension in the aetiology of Dupuytren’s disease; a prospective trial. J Hand Surg Br. 2003;28(6):528–530.
    1. Evans R.B., Dell P.C., Fiolkowski P. A clinical report of the effect of mechanical stress on functional results after fasciectomy for Dupuytren’s contracture. J Hand Ther. 2002;15(4):331–339.
    1. Flowers K.R., LaStayo P. Effect of total end range time on improving passive range of motion. J Hand Ther. 1994;7(3):150–157.
    1. Glasgow C., Fleming J., Tooth L.R., Hockey R.L. The long-term relationship between duration of treatment and contracture resolution using dynamic orthotic devices for the stiff proximal interphalangeal joint: a prospective cohort study. J Hand Ther. 2012;25(1):38–46. quiz 47.
    1. Glasgow C., Wilton J., Tooth L. Optimal daily total end range time for contracture: resolution in hand splinting. J Hand Ther. 2003;16(3):207–218.

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