Comparison of New Suture Anchor Technique for Bony Mallet Injury Versus Conservative Treatment

NCT ID: NCT03228849

Last Updated: 2017-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Finger Injuries Finger Fracture Finger Mallet

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were randomly assigned to surgical or conservative groups. After 6 weeks patients in both groups were started on the same rehabilitation protocol.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conservative Treatment

Patients were treated with 6 weeks with splinting and were then started on physical therapy for 2 weeks.

Group Type ACTIVE_COMPARATOR

Conservative Treatment

Intervention Type PROCEDURE

The injured finger was immobilized in an aluminium splint for 6 weeks. Patients were then started on physical therapy for 2 weeks.

Surgical Treatment

Patients were treated with the new suture anchor technique and after 6 weeks were started on physical therapy for 2 weeks.

Group Type ACTIVE_COMPARATOR

Suture anchor technique

Intervention Type PROCEDURE

Suture anchors were used to attach bony fragment. On week 6, patients were then started on physical therapy for 2 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Suture anchor technique

Suture anchors were used to attach bony fragment. On week 6, patients were then started on physical therapy for 2 weeks.

Intervention Type PROCEDURE

Conservative Treatment

The injured finger was immobilized in an aluminium splint for 6 weeks. Patients were then started on physical therapy for 2 weeks.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hayati Durmaz

Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sefa Giray Batıbay, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND
PMID: 7701632 (View on PubMed)

Salazar Botero S, Hidalgo Diaz JJ, Benaida 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.

Reference Type BACKGROUND
PMID: 27019806 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 22472680 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24839413 (View on PubMed)

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. doi: 10.1016/s0072-968x(83)80006-0.

Reference Type BACKGROUND
PMID: 6884844 (View on PubMed)

Handoll HH, Vaghela MV. Interventions for treating mallet finger injuries. Cochrane Database Syst Rev. 2004;(3):CD004574. doi: 10.1002/14651858.CD004574.pub2.

Reference Type BACKGROUND
PMID: 15266538 (View on PubMed)

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. doi: 10.1016/s0363-5023(78)80038-0.

Reference Type BACKGROUND
PMID: 681720 (View on PubMed)

Smit JM, Beets MR, Zeebregts CJ, Rood A, Welters CFM. Treatment options for mallet finger: a review. Plast Reconstr Surg. 2010 Nov;126(5):1624-1629. doi: 10.1097/PRS.0b013e3181ef8ec8.

Reference Type BACKGROUND
PMID: 21042117 (View on PubMed)

Toker S, Turkmen 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.

Reference Type BACKGROUND
PMID: 26070233 (View on PubMed)

Lubahn JD. Mallet finger fractures: a comparison of open and closed technique. J Hand Surg Am. 1989 Mar;14(2 Pt 2):394-6. doi: 10.1016/0363-5023(89)90121-4. No abstract available.

Reference Type BACKGROUND
PMID: 2732433 (View on PubMed)

Auchincloss JM. Mallet-finger injuries: a prospective, controlled trial of internal and external splintage. Hand. 1982 Jun;14(2):168-73. doi: 10.1016/s0072-968x(82)80011-9. No abstract available.

Reference Type BACKGROUND
PMID: 6749606 (View on PubMed)

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. doi: 10.1016/0363-5023(94)90200-3.

Reference Type BACKGROUND
PMID: 7806817 (View on PubMed)

Jones NF, Peterson J. Epidemiologic study of the mallet finger deformity. J Hand Surg Am. 1988 May;13(3):334-8. doi: 10.1016/s0363-5023(88)80003-0.

Reference Type BACKGROUND
PMID: 3379264 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8278469 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24209945 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26003015 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27780628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27496991 (View on PubMed)

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. doi: 10.1136/emj.10.3.244.

Reference Type BACKGROUND
PMID: 8216604 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27769840 (View on PubMed)

Stern PJ, Kastrup JJ. Complications and prognosis of treatment of mallet finger. J Hand Surg Am. 1988 May;13(3):329-34. doi: 10.1016/s0363-5023(88)80002-9.

Reference Type BACKGROUND
PMID: 3379263 (View on PubMed)

Ulusoy MG, Karalezli N, Kocer 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. doi: 10.1097/01.prs.0000232983.23840.f2.

Reference Type BACKGROUND
PMID: 16932181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20818217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26794127 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18261661 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 18762129 (View on PubMed)

Crawford GP. The molded polythene splint for mallet finger deformities. J Hand Surg Am. 1984 Mar;9(2):231-7. doi: 10.1016/s0363-5023(84)80148-3.

Reference Type BACKGROUND
PMID: 6715831 (View on PubMed)

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. doi: 10.1002/bjs.1800550905. No abstract available.

Reference Type BACKGROUND
PMID: 4877731 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27765527 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014/288

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mallet Finger Splinting Study
NCT01388751 COMPLETED NA