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CompletedNCT03082872Updated Mar 17, 2017

Cemented K-wire Fixation vs Open Transfixion Pinning

An interventional study of Cemented K-wire and Transfixion Pinning in Closed Fracture of Finger and Finger Fracture, sponsored by The Second Hospital of Qinhuangdao. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-03-17.

Sponsored by The Second Hospital of Qinhuangdao · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 years 2 months after the study started (first participant enrolled Jan 2009, registered Mar 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 23 studies in Fractures, Bone with a site in China — 4 open to participants now, 5 under way, none of them phase 3. Fractures, Bone · China.

Enrollment
9th of 20
98 · median 86
Started
2009
with 1 other
No phase
11 of 23
3 open now
Registered
12th of 23
by date
Lead sponsor
2 of 23
The Second Hospital of Qinhuangdao

Among the 23 studies in Fractures, Bone with a site in China, this one is the 9th largest by enrollment of the 20 interventional ones that give a count, is one of 2 that started in 2009, is one of 11 with no phase, and was the 12th registered.

Fractures, Bone

725 studies on the registry are indexed under Fractures, Bone; 116 are open to participants now.

Browse Fractures, Bone studies →

Open to participants now

4 of the 23 studies in Fractures, Bone with a site in China are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 72 Fractures, Bone studies recruiting now, 36 (50%) set no upper age limit and 22 (31%) stop at 75 or younger; 17 take children under 18; 14 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

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02

Study summary

To introduce a novel external-fixation technique using the combination of K-wires and cement, and the objective of this report is also to compare the technique with conventional open transfixion pinning.

Read the detailed description

Shaft fractures of the middle phalanx are common injuries that are often difficult to treat. Currently, fracture fixation is usually achieved by using K-wire, but pin configurations are controversial.The objective of this report is to introduce treatment of shaft fractures of middle phalanx with a novel external-fixation technique using combined K-wires and cement. For comparison, we also included another group of patients who were treated using open transfixion pinning.A total of 98 patients (98 fingers) with shaft fractures of middle phalanx were randomly allocated to group A (n=51) and B (n=47). Fingers in group A were treated with cemented K-wire fixation, and fingers in group B were treated using conventional open transfixion pinning. Time of bone healing, range of motion of the fingers, and joint motion were assessed. A p\<0.05 was considered statistically significant.

03

Conditions studied

  • Closed Fracture of Finger
  • Finger Fracture

Browse trials for

Keywords

  • Reduction, Fracture
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patient aged between 18 and 65 years;
  • acute fractures within 15 days;
  • closed fractures or fractures with small open wound less than 1.5 cm;
  • involvement of single middle phalanges of index to little fingers;
  • shaft fractures; at least 5 mm in length of the most distal and proximal fragments so that K-wires can be secured;
  • transversal, short oblique or spiral fractures;
  • comminuted fractures of middle third phalanx;
  • normal opposite hand for comparison.

Exclusion criteria

Exclusion Criteria:

  • patients younger than 18 years are excluded because of skeletal immaturity;
  • patients older than 65 years are excluded because of possible osteoporosis;
  • multiple finger involvement; severe open injury or crush injuries;
  • combined tendon or neurovascular injuries; involvement of articular surface;
  • old fractures exceeding 15 days because close reduction most likely became difficult;
  • combined tendon, nerve, or artery injuries or diseases;
  • diabetes, gout, ganglion;
  • osseous tumors, and other disease affecting bony structures and joint motion;
  • patients who declined to participate.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
98 participants (actual)

Study arms

  • Experimental
    Cemented K-wire Fixation

    Fractures were transverse (n=32), short oblique or spiral (n=5), and comminuted (n=14) fractures.

    Device: Cemented K-wire · Device: Transfixion Pinning

  • Experimental
    Open Transfixion Pinning

    Fractures were transverse (n=28), short oblique or spiral (n=4), and comminuted (n=15) fractures.

    Device: Cemented K-wire · Device: Transfixion Pinning

Interventions

  • DeviceCemented K-wire

    Fracture of proximal phalanx was treated with Cemented K-wire.

  • DeviceTransfixion Pinning

    Fracture of proximal phalanx was treated with transfixion pinning.

06

What researchers measure

Primary outcomes

  1. Bone healing

    Time of bone healing

    Time frame: Up to 12 weeks. From date of randomization until the date of first documented progression from any cause, which is assessed up to 12 weeks.

Secondary outcomes

  1. Joint motion

    Range of motion of MCP, PIP, and DIP joints

    Time frame: Up to 2 years. From date of randomization until the date of second documented progression from any cause, which is assessed up to 2 years.

Other outcomes

  1. Patient satisfaction

    Patient self assessment based on 100-mm visual analogue scale.

    Time frame: Up to 2 years. From date of randomization until the date of third documented progrssion from any cause, which is assessed up to 2 years.

07

Study locations

1 site
  • Third Hospital of Hebei Medical University
    Shijiazhuang, Hebei 050051, China
08

References and documents

Publications

  • Edwards GS Jr, O'Brien ET, Heckman MM. Retrograde cross-pinning of transverse metacarpal and phalangeal fractures. Hand. 1982 Jun;14(2):141-8. doi: 10.1016/s0072-968x(82)80005-3. No abstract available. PubMed 7117927 ↗
  • Margic K. External fixation of closed metacarpal and phalangeal fractures of digits. A prospective study of one hundred consecutive patients. J Hand Surg Br. 2006 Feb;31(1):30-40. doi: 10.1016/j.jhsb.2005.09.013. Epub 2005 Nov 15. PubMed 16293357 ↗
  • Gaston RG, Chadderdon C. Phalangeal fractures: displaced/nondisplaced. Hand Clin. 2012 Aug;28(3):395-401, x. doi: 10.1016/j.hcl.2012.05.032. Epub 2012 Jun 26. PubMed 22883890 ↗

Individual participant data

Plan to share: No — No plan to share the IPD data

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2009 to primary completion in Jan 2015, 72 months.

Of 148 non-industry interventional studies with no phase under Fractures, Bone, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 57. This study's 72 months is above that.

Counting every sponsor, half of 166 studies reached it within 29 months; a quarter within 12 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2017
First posted
Mar 17, 2017
StartActual
Jan 1, 2009
Primary completionActual
Jan 30, 2015
CompletionActual
Jan 30, 2015
Last update
Mar 17, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03082872
Lead sponsor
The Second Hospital of Qinhuangdao
Responsible party
Sponsor
First posted
Mar 17, 2017
Start date
Jan 1, 2009
Primary completion
Jan 30, 2015
Completion
Jan 30, 2015
Last update
Mar 17, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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