Bony Mallet FingerNCT01072760
Kirschner Wire and Pull-out Wire Fixation for the Treatment of Bony Mallet Finger
A study testing K wire in people with Bony Mallet Finger, run by The Second Hospital of Qinhuangdao at 1 site in China.
Trial summary
The objective of this report is to describe a new surgical technique for the treatment of bony mallet finger which involves the application of both Kirschner wire and pull-out wire fixation. It is believed to decrease the risk of the complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bony Mallet Finger
- What is being tested?
- K wire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- May 2003to Feb 2009
- 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
- bony mallet finger;
- patient had failed trials of nonsurgical treatment;
- fracture involving more than 1/3 of the joint surface;
- fragment displacement or subluxation of the DIP joint.
Who cannot join
- tendinous mallet finger;
- success of nonsurgical treatment;
- comminuted fracture;
- fracture involving at or less than 1/3 of the joint surface which could be successfully replaced with nonsurgical treatment.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this report is to describe a new surgical technique for the treatment of bony mallet finger which involves the application of both Kirschner wire and pull-out wire fixation. It is believed to decrease the risk of the complications.
Read the detailed description
From May 2003 to December 2008, we used Kirschner wire and pull-out wire fixation to carry out 54 closed bony mallet finger in 54 patients. The bony mallet finger was applicated both Kirschner wire and pull-out wire fixation.
- Conditions
- Bony Mallet Finger
- Being tested
- K wire
- Keywords
- Mallet finger, extensor tendon, Kirschner wire, Fracture Fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K wireProcedure or surgery
Also called stainless steel wire
Mallet finger treatment
| Study group | Role | What they receive |
|---|---|---|
| K wire | Experimental | Not described Receives: Procedure: K wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The digits were assessed for skin necrosis, skin breakdown, infection.
Measured: 15 days
Secondary outcomes (1)
The patients rated their pain experience by a visual analogue scale. The results were graded by Crawford's criteria.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startMay 2003
- Primary completionDec 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bony Mallet FingerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Qinhuangdao
- Sponsor type
- University, hospital or other
- Investigators
- Sumin Wen, M.D., Principal investigator, The Second Hospital of Qinhuangdao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072760
- Sponsor's protocol ID
- QHD201002
- Other IDs
- QHD20010201
- Status last verified
- Feb 2010
- First submitted
- 12 Feb 2010
- Last updated
- 22 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee YH, Kim JY, Chung MS, Baek GH, Gong HS, Lee SK. Two extension block Kirschner wire technique for mallet finger fractures. J Bone Joint Surg Br. 2009 Nov;91(11):1478-81. doi: 10.1302/0301-620X.91B11.22478.
PubMed 19880893
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kirschner Wire and Pull-out Wire Fixation for the Treatment of Bony Mallet Finger
- ClinicalTrials.gov ID
- NCT01072760
- Acronym / sponsor ID
- QHD201002
- Conditions
- Bony Mallet Finger
- Keywords
- Mallet finger, extensor tendon, Kirschner wire, Fracture Fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- The Second Hospital of QinhuangdaoUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 22 Feb 2010 (estimated)
- 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.
The objective of this report is to describe a new surgical technique for the treatment of bony mallet finger which involves the application of both Kirschner wire and pull-out wire fixation. It is believed to decrease the risk of the complications.
Detailed description
From May 2003 to December 2008, we used Kirschner wire and pull-out wire fixation to carry out 54 closed bony mallet finger in 54 patients. The bony mallet finger was applicated both Kirschner wire and pull-out wire fixation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| K wire | Experimental | Procedure: K wire |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- bony mallet finger;
- patient had failed trials of nonsurgical treatment;
- fracture involving more than 1/3 of the joint surface;
- fragment displacement or subluxation of the DIP joint.
Key exclusion criteria (4 listed)
- tendinous mallet finger;
- success of nonsurgical treatment;
- comminuted fracture;
- fracture involving at or less than 1/3 of the joint surface which could be successfully replaced with nonsurgical treatment.
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 |
|---|---|---|
| K wireAlso: stainless steel wireMallet finger treatment | Procedure or surgery | K wire |
Primary outcome
The digits were assessed for skin necrosis, skin breakdown, infection.
Time frame: 15 days
1 secondary outcome
The patients rated their pain experience by a visual analogue scale. The results were graded by Crawford's criteria.
Time frame: 1 year
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 22 Feb 2010.
- Results publication: PubMed 19880893Lee YH, Kim JY, Chung MS, Baek GH, Gong HS, Lee SK. Two extension block Kirschner wire technique for mallet finger fractures. J Bone Joint Surg Br. 2009 Nov;91(11):1478-81. doi: 10.1302/0301-620X.91B11.22478.
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.
Sumin Wen, M.D. principal investigator
The Second Hospital of Qinhuangdao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing K wire in people with Bony Mallet Finger, run by The Second Hospital of Qinhuangdao at 1 site in China.
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 4 inclusion and 4 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 22 Feb 2010. 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 China. 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?
The digits were assessed for skin necrosis, skin breakdown, infection. (time frame: 15 days). 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 NCT01072760, which also lists 1 linked publication.
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 22 Feb 2010.