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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03228849
Other study ID # 2014/288
Secondary ID
Status Completed
Phase N/A
First received July 18, 2017
Last updated July 22, 2017
Start date June 2013
Est. completion date July 2015

Study information

Verified date July 2017
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to compare conservative treatment versus a new suture anchor technique for bony mallet finger in 29 patients.


Description:

This study aims to compare conservative treatment versus a new suture anchor technique for bony mallet finger in 29 patients who presented to investigators' clinic between 2013 and 2015. Patients were randomly assigned to conservative or surgical treatment groups. Patients in the conservative group were followed with immobilization with aluminum splint and physical therapy. Patients in the surgical group were treated with investigators' new surgical suture anchor technique and then received physical therapy. The patients were followed for 12 months. Primary study outcomes were extension deficit, days to return to work and DIP flexion.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date July 2015
Est. primary completion date June 15, 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Wehbe Schneider type 1 - 2 and type A - B fractures

- ability to provide closed reduction

- patients' voluntariness

Exclusion Criteria:

- Wehbe Schneider type C and type 3 fractures

Study Design


Intervention

Procedure:
Suture anchor technique
Suture anchors were used to attach bony fragment. On week 6, patients were then started on physical therapy for 2 weeks.
Conservative Treatment
The injured finger was immobilized in an aluminium splint for 6 weeks. Patients were then started on physical therapy for 2 weeks.

Locations

Country Name City State
Turkey Istanbul University Faculty of Medicine Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (29)

Abouna JM, Brown H. The treatment of mallet finger. The results in a series of 148 consecutive cases and a review of the literature. Br J Surg. 1968 Sep;55(9):653-67. — View Citation

Alla SR, Deal ND, Dempsey IJ. Current concepts: mallet finger. Hand (N Y). 2014 Jun;9(2):138-44. doi: 10.1007/s11552-014-9609-y. — View Citation

Angermann P, Lohmann M. [Hand and wrist injuries. A study of 50.272 injuries]. Ugeskr Laeger. 1995 Feb 6;157(6):734-7. Danish. — View Citation

Auchincloss JM. Mallet-finger injuries: a prospective, controlled trial of internal and external splintage. Hand. 1982 Jun;14(2):168-73. — View Citation

Crawford GP. The molded polythene splint for mallet finger deformities. J Hand Surg Am. 1984 Mar;9(2):231-7. — View Citation

Eddy M. Hands, fingers, thumbs - assessment and management of common hand injuries in general practice. Aust Fam Physician. 2012 Apr;41(4):202-9. — View Citation

Garberman SF, Diao E, Peimer CA. Mallet finger: results of early versus delayed closed treatment. J Hand Surg Am. 1994 Sep;19(5):850-2. — View Citation

Hamas RS, Horrell ED, Pierret GP. Treatment of mallet finger due to intra-articular fracture of the distal phalanx. J Hand Surg Am. 1978 Jul;3(4):361-3. — View Citation

Handoll HH, Vaghela MV. Interventions for treating mallet finger injuries. Cochrane Database Syst Rev. 2004;(3):CD004574. Review. — View Citation

Husain SN, Dietz JF, Kalainov DM, Lautenschlager EP. A biomechanical study of distal interphalangeal joint subluxation after mallet fracture injury. J Hand Surg Am. 2008 Jan;33(1):26-30. doi: 10.1016/j.jhsa.2007.09.006. — View Citation

Jones NF, Peterson J. Epidemiologic study of the mallet finger deformity. J Hand Surg Am. 1988 May;13(3):334-8. — View Citation

Kim JY, Lee SH. Factors Related to Distal Interphalangeal Joint Extension Loss After Extension Block Pinning of Mallet Finger Fractures. J Hand Surg Am. 2016 Mar;41(3):414-9. doi: 10.1016/j.jhsa.2015.11.026. Epub 2016 Jan 12. — View Citation

Lubahn JD. Mallet finger fractures: a comparison of open and closed technique. J Hand Surg Am. 1989 Mar;14(2 Pt 2):394-6. — View Citation

Maitra A, Dorani B. The conservative treatment of mallet finger with a simple splint: a case report. Arch Emerg Med. 1993 Sep;10(3):244-8. — View Citation

Mak L, Aitkens LD, Novak CB. Mallet finger injuries-A new method to maintain distal interphalangeal joint extension. J Hand Ther. 2016 Jul-Sep;29(3):352-5. doi: 10.1016/j.jht.2016.01.002. Epub 2016 Feb 9. — View Citation

Moss JG, Steingold RF. The long term results of mallet finger injury. A retrospective study of one hundred cases. Hand. 1983 Jun;15(2):151-4. — View Citation

Nakamura K, Nanjyo B. Reassessment of surgery for mallet finger. Plast Reconstr Surg. 1994 Jan;93(1):141-9; discussion 150-1. — View Citation

Panchal-Kildare S, Malone K. Skeletal anatomy of the hand. Hand Clin. 2013 Nov;29(4):459-71. doi: 10.1016/j.hcl.2013.08.001. — View Citation

Phadnis J, Yousaf S, Little N, Chidambaram R, Mok D. Open reduction internal fixation of the unstable mallet fracture. Tech Hand Up Extrem Surg. 2010 Sep;14(3):155-9. doi: 10.1097/BTH.0b013e3181d13800. — View Citation

Roh YH, Lee BK, Park MH, Noh JH, Gong HS, Baek GH. Effects of health literacy on treatment outcome and satisfaction in patients with mallet finger injury. J Hand Ther. 2016 Oct - Dec;29(4):459-464. doi: 10.1016/j.jht.2016.06.004. Epub 2016 Oct 17. — View Citation

Saito K, Kihara H. A randomized controlled trial of the effect of 2-step orthosis treatment for a mallet finger of tendinous origin. J Hand Ther. 2016 Oct - Dec;29(4):433-439. doi: 10.1016/j.jht.2016.07.005. Epub 2016 Oct 18. — View Citation

Salazar Botero S, Hidalgo Diaz JJ, Benaïda A, Collon S, Facca S, Liverneaux PA. Review of Acute Traumatic Closed Mallet Finger Injuries in Adults. Arch Plast Surg. 2016 Mar;43(2):134-44. doi: 10.5999/aps.2016.43.2.134. Epub 2016 Mar 18. Review. — View Citation

Schneider LH. A biomechanical study of distal interphalangeal joint subluxation after mallet fracture injury. J Hand Surg Am. 2008 Sep;33(7):1248-9; author reply 1249. doi: 10.1016/j.jhsa.2008.04.014. — View Citation

Smit JM, Beets MR, Zeebregts CJ, Rood A, Welters CF. Treatment options for mallet finger: a review. Plast Reconstr Surg. 2010 Nov;126(5):1624-9. doi: 10.1097/PRS.0b013e3181ef8ec8. Review. — View Citation

Stern PJ, Kastrup JJ. Complications and prognosis of treatment of mallet finger. J Hand Surg Am. 1988 May;13(3):329-34. — View Citation

Toker S, Türkmen F, Pekince O, Korucu I, Karalezli N. Extension Block Pinning Versus Hook Plate Fixation for Treatment of Mallet Fractures. J Hand Surg Am. 2015 Aug;40(8):1591-6. doi: 10.1016/j.jhsa.2015.04.027. Epub 2015 Jun 10. — View Citation

Ulusoy MG, Karalezli N, Koçer U, Uysal A, Karaaslan O, Kankaya Y, Aslan C. Pull-in suture technique for the treatment of mallet finger. Plast Reconstr Surg. 2006 Sep;118(3):696-702. — View Citation

Valdes K, Naughton N, Algar L. Conservative treatment of mallet finger: A systematic review. J Hand Ther. 2015 Jul-Sep;28(3):237-45; quiz 246. doi: 10.1016/j.jht.2015.03.001. Epub 2015 Mar 10. Review. — View Citation

Valdes K, Naughton N, Algar L. ICF components of outcome measures for mallet finger: A systematic review. J Hand Ther. 2016 Oct - Dec;29(4):388-395. doi: 10.1016/j.jht.2016.06.005. Epub 2016 Oct 22. — View Citation

* Note: There are 29 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Extension deficit The inability to actively extend DIP joint to 0 degrees. 12 months
Primary DIP flexion The maximum angle of flexion at DIP joint 12 months
Primary Days to return to work Time to return to work Starting from the date of the start of treatment until patients returns to work, assessed up to 12 months
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