Cemented K-wire Fixation vs Open Transfixion Pinning

March 12, 2017 updated by: The Second Hospital of Qinhuangdao

Randomized Comparison Between Cemented K-wire Fixation vs Open Transfixion Pinning for the Treatment of Shaft Fractures of Middle Phalanges

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • Third Hospital of Hebei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Fracture of proximal phalanx was treated with Cemented K-wire.
Device: Transfixion Pinning
Fracture of proximal phalanx was treated with 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
Fracture of proximal phalanx was treated with Cemented K-wire.
Device: Transfixion Pinning
Fracture of proximal phalanx was treated with transfixion pinning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time of bone healing
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Joint motion
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.
Range of motion of MCP, PIP, and DIP joints
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
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.
Patient self assessment based on 100-mm visual analogue scale.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Qinhuangdao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

January 30, 2015

Study Completion (Actual)

January 30, 2015

Study Registration Dates

First Submitted

March 7, 2017

First Submitted That Met QC Criteria

March 12, 2017

First Posted (Actual)

March 17, 2017

Study Record Updates

Last Update Posted (Actual)

March 17, 2017

Last Update Submitted That Met QC Criteria

March 12, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THHMU201763

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan to share the IPD data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Finger Fracture

Clinical Trials on Cemented K-wire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe