Cemented K-wire Fixation vs Open Transfixion Pinning

Finger Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082872
• Other study ID #: THHMU201763
• Status: Completed
• Phase: N/A
• First received: March 7, 2017
• Last updated: March 12, 2017
• Start date: January 1, 2009
• Est. completion date: January 30, 2015

Study information

• Verified date: March 2017
• Source: The Second Hospital of Qinhuangdao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 30, 2015
• Est. primary completion date: January 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Closed Fracture of Finger
• Finger Fracture
• Fractures, Bone
• Fractures, Closed

Intervention

Device:
• Cemented K-wire
Fracture of proximal phalanx was treated with Cemented K-wire.
• Transfixion Pinning
Fracture of proximal phalanx was treated with transfixion pinning.

Locations

Country	Name	City	State
China	Third Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Qinhuangdao

Country where clinical trial is conducted

China, 

References & Publications (3)

Edwards GS Jr, O'Brien ET, Heckman MM. Retrograde cross-pinning of transverse metacarpal and phalangeal fractures. Hand. 1982 Jun;14(2):141-8. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction	Patient self assessment based on 100-mm visual analogue scale.	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.
Primary	Bone healing	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	Joint motion	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.