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Cemented K-wire Fixation vs Open Transfixion Pinning

Primary Purpose

Closed Fracture of Finger, Finger Fracture

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cemented K-wire
Transfixion Pinning
Sponsored by
The Second Hospital of Qinhuangdao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Closed Fracture of Finger focused on measuring Reduction, Fracture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Third Hospital of Hebei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cemented K-wire Fixation

Open Transfixion Pinning

Arm Description

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

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

Outcomes

Primary Outcome Measures

Bone healing
Time of bone healing

Secondary Outcome Measures

Joint motion
Range of motion of MCP, PIP, and DIP joints

Full Information

First Posted
March 7, 2017
Last Updated
March 12, 2017
Sponsor
The Second Hospital of Qinhuangdao
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1. Study Identification

Unique Protocol Identification Number
NCT03082872
Brief Title
Cemented K-wire Fixation vs Open Transfixion Pinning
Official Title
Randomized Comparison Between Cemented K-wire Fixation vs Open Transfixion Pinning for the Treatment of Shaft Fractures of Middle Phalanges
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2009 (Actual)
Primary Completion Date
January 30, 2015 (Actual)
Study Completion Date
January 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Qinhuangdao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed Fracture of Finger, Finger Fracture
Keywords
Reduction, Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients with middle proximal fractures of fingers
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Blinded
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cemented K-wire Fixation
Arm Type
Experimental
Arm Description
Fractures were transverse (n=32), short oblique or spiral (n=5), and comminuted (n=14) fractures.
Arm Title
Open Transfixion Pinning
Arm Type
Experimental
Arm Description
Fractures were transverse (n=28), short oblique or spiral (n=4), and comminuted (n=15) fractures.
Intervention Type
Device
Intervention Name(s)
Cemented K-wire
Intervention Description
Fracture of proximal phalanx was treated with Cemented K-wire.
Intervention Type
Device
Intervention Name(s)
Transfixion Pinning
Intervention Description
Fracture of proximal phalanx was treated with transfixion pinning.
Primary Outcome Measure Information:
Title
Bone healing
Description
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 Outcome Measure Information:
Title
Joint motion
Description
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 Pre-specified Outcome Measures:
Title
Patient satisfaction
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Third Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share the IPD data
Citations:
PubMed Identifier
7117927
Citation
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.
Results Reference
result
PubMed Identifier
16293357
Citation
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.
Results Reference
result
PubMed Identifier
22883890
Citation
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.
Results Reference
result

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Cemented K-wire Fixation vs Open Transfixion Pinning

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