Cemented K-wire Fixation vs Plating for Finger Fractures

Not Applicable

Completed

• Conditions: Closed Fracture of Finger; Finger Fracture Open

• Registration Number: NCT03031015
• Lead Sponsor: The Second Hospital of Qinhuangdao

Brief Summary

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.

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 Timeline

• Study Start: 2011-01-01
• Primary Completion: 2014-05-01
• Study Completion: 2014-05-01
• Status Verified: 2017-01
• Study First Submitted: 2017-01-19
• Study First Submitted QC: 2017-01-21
• Last Update Submitted: 2017-01-21
• Study First Posted: 2017-01-25
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	Time of bone healing.

Secondary Outcome Measures

Name	Time	Method
Joint motion	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.

Trial Locations

Locations (1)

Third Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China