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CompletedNCT03031015CKFPFFUpdated Jan 25, 2017

Cemented K-wire Fixation vs Plating for Finger Fractures

An interventional study of Cemented K-wire Fixation and Plating in Closed Fracture of Finger and Finger Fracture Open, 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 2017-01-25.

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

From the registry’s dates

  • Registered 6 years after the study started (first participant enrolled Jan 2011, registered Jan 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
131
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
6th of 20
131 · median 86
Started
2011
with 1 other
No phase
11 of 23
3 open now
Registered
11th 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 6th largest by enrollment of the 20 interventional ones that give a count, is one of 2 that started in 2011, is one of 11 with no phase, and was the 11th 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. For comparison, we also included another group of patients who were treated using a mini plate and screw system. Bone healing, range of motion of the fingers, costs of treatments, and patient satisfaction were assessed.

Read the detailed description

Shaft fractures of the proximal phalanx are common injuries that may significantly affect hand function. Good fracture stability to allow early mobilization of joints and thus early return of function. The objective of this report is to introduce a novel external-fixation technique using the combination of K-wires and cement. For comparison, we also included another group of patients who were treated using a mini plate and screw system. A total of 104 patients (131 fingers) were randomly allocated into group A (56 patients) and B (51 patients). Patients in group A were treated with cemented K-wire fixation; and patients in group B were treated with conventional mini-plate. Bone healing, range of motion of the fingers, costs of treatments, and patient satisfaction were assessed.

03

Conditions studied

  • Closed Fracture of Finger
  • Finger Fracture Open

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 fracture or open injury with small wound less than 1.5 cm;
  • involvement of proximal phalanges of index to little fingers; shaft fractures;
  • at least 5 mm in length of the most distal and proximal fragments so that the K-wires or screws can be engaged;
  • oblique, spiral, and comminuted fractures;
  • 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;
  • severe open injury or crush injuries; tendon or neurovascular injuries; - involvement of articular surface;
  • old fractures exceeding 15 days because close reduction was most likely difficult;
  • a 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
131 participants (actual)

Study arms

  • Experimental
    Cemented K-wire Fixation

    The mean age of group A was 41 years (range, 18-63 years). There were 56 male and 11 female patients. The mean time from injury to operation was 5±4.53 days. Injured digits included index (n=24), long (n=19), ring (n=9), and little (n=15) fingers. Types of fractures were transversal (n=31), oblique or spiral (n=14), and comminuted (n=22) fractures. The patients were treated with Cemented K-wire Fixation.

    Device: Cemented K-wire Fixation · Device: Plating

  • Active comparator
    Plating

    The mean age of group A was 39 years (range, 19-61 years). There were 51 male and 13 female patients. The mean time from injury to operation was 6±5.53 days. Injured digits included index (n=21), long (n=17), ring (n=10), and little (n=16) fingers. Types of fractures were transversal (n=34), oblique or spiral (n=11), and comminuted (n=19) fractures.The patients were treated with Plating.

    Device: Cemented K-wire Fixation · Device: Plating

Interventions

  • DeviceCemented K-wire Fixation

    Fractures were reduced and then fixed with cemented K-wires.

  • DevicePlating

    Fractures were reduced and then fixed with Plate.

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 progression 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

  • Miller L, Ada L, Crosbie J, Wajon A. Pattern of recovery after open reduction and internal fixation of proximal phalangeal fractures in the finger: a prospective longitudinal study. J Hand Surg Eur Vol. 2017 Feb;42(2):137-143. doi: 10.1177/1753193416670591. Epub 2016 Oct 4. PubMed 27702779 ↗
  • Borbas P, Dreu M, Poggetti A, Calcagni M, Giesen T. Treatment of proximal phalangeal fractures with an antegrade intramedullary screw: a cadaver study. J Hand Surg Eur Vol. 2016 Sep;41(7):683-7. doi: 10.1177/1753193416641319. Epub 2016 Apr 7. Erratum In: J Hand Surg Eur Vol. 2016 Sep;41(7):NP1. doi: 10.1177/1753193416648263. PubMed 27056278 ↗
  • Miller L, Crosbie J, Wajon A, Ada L. No difference between two types of exercise after proximal phalangeal fracture fixation: a randomised trial. J Physiother. 2016 Jan;62(1):12-9. doi: 10.1016/j.jphys.2015.11.006. Epub 2015 Dec 14. PubMed 26699692 ↗
  • Zhang X, Yu Y, Shao X, Dhawan V, Du W. A randomized comparison of bone-cement K-wire fixation vs. plate fixation of shaft fractures of proximal phalanges. Phys Sportsmed. 2019 May;47(2):189-198. doi: 10.1080/00913847.2018.1546106. Epub 2018 Nov 14. PubMed 30408421 ↗

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 2011 to primary completion in May 2014, 40 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 40 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
Jan 19, 2017
First posted
Jan 25, 2017
StartActual
Jan 1, 2011
Primary completionActual
May 1, 2014
CompletionActual
May 1, 2014
Last update
Jan 25, 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 Jan 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03031015
Lead sponsor
The Second Hospital of Qinhuangdao
Responsible party
Sponsor
First posted
Jan 25, 2017
Start date
Jan 1, 2011
Primary completion
May 1, 2014
Completion
May 1, 2014
Last update
Jan 25, 2017

Study contacts

Xu Zhang, MD
study chair · Third Hospital of Hebei Medical University
Xinzhong Shao, MD
principal investigator · Third Hospital of Hebei Medical University

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 Jan 2017. You cannot join it, but the record below documents what was studied.

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