Cemented K-wire Fixation vs Plating for Finger Fractures (CKFPFF)

January 21, 2017 updated by: The Second Hospital of Qinhuangdao

Randomized Comparison of Cemented K-wire Fixation and Plating of Shaft Fractures of Proximal Phalanges

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

131

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

18 years to 65 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 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:

  • 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.

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
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
Fractures were reduced and then fixed with cemented K-wires.
Device: Plating
Fractures were reduced and then fixed with Plate.
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
Fractures were reduced and then fixed with cemented K-wires.
Device: Plating
Fractures were reduced and then fixed with Plate.

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 progression 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 progression 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

Investigators

  • Study Chair: Xu Zhang, MD, Third Hospital of Hebei Medical University
  • Principal Investigator: Xinzhong Shao, MD, Third Hospital of Hebei Medical University

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, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

January 19, 2017

First Submitted That Met QC Criteria

January 21, 2017

First Posted (Estimate)

January 25, 2017

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 21, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THHMU201701

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.

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