Finger InjuriesNCT03228849

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

A study testing Suture anchor technique and Conservative Treatment in people with Finger Injuries and Finger Fracture, run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Any age
Conditions the study is for: Finger Injuries, Finger Fracture, Finger Mallet
What is being tested?: Suture anchor technique and Conservative Treatment
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Jun 2013to Jul 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Wehbe Schneider type 1 - 2 and type A - B fractures
ability to provide closed reduction
patients' voluntariness

Who cannot join

Wehbe Schneider type C and type 3 fractures

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul University Faculty of Medicine
Istanbul, 34093

Other trials in Turkey (Türkiye)

About this study

Official title: Conservative Management Equally Effective to New Suture Anchor Technique for Acute Mallet Finger Deformity: A Prospective Randomized Clinical Trial

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

Read the detailed 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.

Conditions: Finger Injuries, Finger Fracture, Finger Mallet
Being tested: Suture anchor technique, Conservative Treatment
Keywords: Bony mallet injury, Anchor suture, Conservative treatment, DIP joint
Medical subject headings: Finger Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03228849
Study group	Role	What they receive
Conservative Treatment	Active comparator	Patients were treated with 6 weeks with splinting and were then started on physical therapy for 2 weeks. Receives: Procedure: Conservative Treatment
Surgical Treatment	Active comparator	Patients were treated with the new suture anchor technique and after 6 weeks were started on physical therapy for 2 weeks. Receives: Procedure: Suture anchor technique

What is being measured

The primary outcome is the main question the study is designed to answer.

Extension deficit
The inability to actively extend DIP joint to 0 degrees.
Measured: 12 months
DIP flexion
The maximum angle of flexion at DIP joint
Measured: 12 months
Days to return to work
Time to return to work
Measured: Starting from the date of the start of treatment until patients returns to work, assessed up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Jul 2015

First posted25 Jul 2017
Study startJun 2013
Primary completion15 Jun 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Finger InjuriesStudies of the same condition, open and under way.
More trials run by Istanbul UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients were randomly assigned to surgical or conservative groups. After 6 weeks patients in both groups were started on the same rehabilitation protocol.
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03228849
Sponsor's protocol ID: 2014/288
Status last verified: Jul 2017
First submitted: 18 Jul 2017
Last updated: 25 Jul 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No consent was obtained from the patients specifically to share their participant data.

Publications

Angermann P, Lohmann M. [Hand and wrist injuries. A study of 50.272 injuries]. Ugeskr Laeger. 1995 Feb 6;157(6):734-7. Danish.
PubMed 7701632
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.
PubMed 27019806
Eddy M. Hands, fingers, thumbs - assessment and management of common hand injuries in general practice. Aust Fam Physician. 2012 Apr;41(4):202-9.
PubMed 22472680
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.
PubMed 24839413
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.
PubMed 6884844
Handoll HH, Vaghela MV. Interventions for treating mallet finger injuries. Cochrane Database Syst Rev. 2004;2004(3):CD004574. doi: 10.1002/14651858.CD004574.pub2.
PubMed 15266538
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.
PubMed 681720
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.
PubMed 21042117
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.
PubMed 26070233
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.
PubMed 2732433
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.
PubMed 6749606
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.
PubMed 7806817
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.
PubMed 3379264
Nakamura K, Nanjyo B. Reassessment of surgery for mallet finger. Plast Reconstr Surg. 1994 Jan;93(1):141-9; discussion 150-1.
PubMed 8278469
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.
PubMed 24209945

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Conservative Treatment With Relative Motion Flexion Orthosis for Boutonniere Injuries in Fingers
Finger Joint Deformities, Tendon Injuries
Not yet recruiting
Study Evaluating the Safety and Efficacy of the TMChM Prosthesis in the Treatment of People With Chronic Flexor Tendon Fingers Injuries
Tendon Injuries
Not yet recruiting
Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers
Hand Fractures
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
RecruitingPhase 4
Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Osteoarthritis, Tendinopathy

All Finger Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Conservative Management Equally Effective to New Suture Anchor Technique for Acute Mallet Finger Deformity: A Prospective Randomized Clinical Trial
ClinicalTrials.gov ID: NCT03228849
Acronym / sponsor ID: 2014/288
Conditions: Finger Injuries, Finger Fracture, Finger Mallet
Keywords: Bony mallet injury, Anchor suture, Conservative treatment, DIP joint
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Istanbul UniversityUniversity, hospital or other
Study start: Jun 2013 (actual)
Primary completion: 15 Jun 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 25 Jul 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Patients were randomly assigned to surgical or conservative groups. After 6 weeks patients in both groups were started on the same rehabilitation protocol.

Arm	Type	Receives
Conservative Treatment	Active comparator	Procedure: Conservative TreatmentPatients were treated with 6 weeks with splinting and were then started on physical therapy for 2 weeks.
Surgical Treatment	Active comparator	Procedure: Suture anchor techniquePatients were treated with the new suture anchor technique and after 6 weeks were started on physical therapy for 2 weeks.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Wehbe Schneider type 1 - 2 and type A - B fractures
ability to provide closed reduction
patients' voluntariness

Key exclusion criteria (1 listed)

Wehbe Schneider type C and type 3 fractures

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Suture anchor techniqueSuture anchors were used to attach bony fragment. On week 6, patients were then started on physical therapy for 2 weeks.	Procedure or surgery	Surgical Treatment
Conservative TreatmentThe injured finger was immobilized in an aluminium splint for 6 weeks. Patients were then started on physical therapy for 2 weeks.	Procedure or surgery	Conservative Treatment

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
Background: PubMed 7701632Angermann P, Lohmann M. [Hand and wrist injuries. A study of 50.272 injuries]. Ugeskr Laeger. 1995 Feb 6;157(6):734-7. Danish.
Background: PubMed 27019806Salazar 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.
Background: PubMed 22472680Eddy M. Hands, fingers, thumbs - assessment and management of common hand injuries in general practice. Aust Fam Physician. 2012 Apr;41(4):202-9.
Background: PubMed 24839413Alla 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.
Background: PubMed 6884844Moss 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.
Background: PubMed 15266538Handoll HH, Vaghela MV. Interventions for treating mallet finger injuries. Cochrane Database Syst Rev. 2004;2004(3):CD004574. doi: 10.1002/14651858.CD004574.pub2.
Background: PubMed 681720Hamas 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.
Background: PubMed 21042117Smit 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.
Background: PubMed 26070233Toker 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.
Background: PubMed 2732433Lubahn 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.
Background: PubMed 6749606Auchincloss 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.
Background: PubMed 7806817Garberman 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.
Individual participant dataSharing planned: No. No consent was obtained from the patients specifically to share their participant data.

Related trials for Finger Injuries

Recruiting
Conservative Treatment With Relative Motion Flexion Orthosis for Boutonniere Injuries in Fingers
Finger Joint Deformities, Tendon Injuries
Not yet recruiting
Study Evaluating the Safety and Efficacy of the TMChM Prosthesis in the Treatment of People With Chronic Flexor Tendon Fingers Injuries
Tendon Injuries
Not yet recruiting
Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers
Hand Fractures
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
RecruitingPhase 4
Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Osteoarthritis, Tendinopathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sefa Giray Batıbay, MD principal investigator

Istanbul University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Suture anchor technique and Conservative Treatment in people with Finger Injuries and Finger Fracture, run by Istanbul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extension deficit (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03228849, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.