Cemented K-wire Fixation vs Plating for Finger Fractures

Closed Fracture of Finger Clinical Trial

— CKFPFF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031015
• Other study ID #: THHMU201701
• Status: Completed
• Phase: N/A
• First received: January 19, 2017
• Last updated: January 21, 2017
• Start date: January 1, 2011
• Est. completion date: May 1, 2014

Study information

• Verified date: January 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: May 1, 2014
• Est. primary completion date: May 1, 2014
• 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 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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Cemented K-wire Fixation
Fractures were reduced and then fixed with cemented K-wires.
• Plating
Fractures were reduced and then fixed with Plate.

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)

Borbas P, Dreu M, Poggetti A, Calcagni M, Giesen T. Treatment of proximal phalangeal fractures with an antegrade intramedullary screw: a cadaver study. J Hand Surg Eur Vol. 2016 Sep;41(7):683-7. doi: 10.1177/1753193416641319. Erratum in: J Hand Surg Eur V — View Citation

Miller L, Ada L, Crosbie J, Wajon A. Pattern of recovery after open reduction and internal fixation of proximal phalangeal fractures in the finger: a prospective longitudinal study. J Hand Surg Eur Vol. 2016 Oct 3. pii: 1753193416670591. [Epub ahead of pr — View Citation

Miller L, Crosbie J, Wajon A, Ada L. No difference between two types of exercise after proximal phalangeal fracture fixation: a randomised trial. J Physiother. 2016 Jan;62(1):12-9. doi: 10.1016/j.jphys.2015.11.006. — 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 progression 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.