Clinical trial NCT03031015: Cemented K-wire Fixation vs Plating for Finger Fractures
Official title: Randomized Comparison of Cemented K-wire Fixation and Plating of Shaft Fractures of Proximal Phalanges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Closed Fracture of Finger
Finger Fracture Open
Keywords: Reduction, Fracture
Lead sponsor: The Second Hospital of Qinhuangdao
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with proximal phalangeal fractures of fingers.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone healing
timeFrame: 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 outcomes:
measure: Joint motion
timeFrame: 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.
Other outcomes:
measure: Patient satisfaction.
timeFrame: 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.
Locations:
city: Shijiazhuang
country: China
facility: Third Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: Third Hospital of Hebei Medical University
name: Xu Zhang, MD
role: STUDY_CHAIR
affiliation: Third Hospital of Hebei Medical University
name: Xinzhong Shao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. 2017 Feb;42(2):137-143. doi: 10.1177/1753193416670591. Epub 2016 Oct 4.
citation: 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. Epub 2016 Apr 7.
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. Epub 2015 Dec 14.
citation: Zhang X, Yu Y, Shao X, Dhawan V, Du W. A randomized comparison of bone-cement K-wire fixation vs. plate fixation of shaft fractures of proximal phalanges. Phys Sportsmed. 2019 May;47(2):189-198. doi: 10.1080/00913847.2018.1546106. Epub 2018 Nov 14.