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OpenTrials
Completed

NCT Number: NCT03031015

Cemented K-wire Fixation vs Plating for Finger Fractures

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.

Completed

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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 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.

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 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.

Treatment and study plan

Cemented K-wire Fixation

Device

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

Plating

Device

Fractures were reduced and then fixed with Plate.

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

Acronym: CKFPFF

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 25, 2017
Registry last updated
Jan 25, 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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