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Completed

NCT Number: NCT03082872

Cemented K-wire Fixation vs Open Transfixion Pinning

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050051, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cemented K-wire

Device

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

Transfixion Pinning

Device

Fracture of proximal phalanx was treated with transfixion pinning.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

The Second Hospital of Qinhuangdao

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Mar 17, 2017
Registry last updated
Mar 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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