Clinical trial NCT03082872: Cemented K-wire Fixation vs Open Transfixion Pinning
Official title: Randomized Comparison Between Cemented K-wire Fixation vs Open Transfixion Pinning for the Treatment of Shaft Fractures of Middle Phalanges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Closed Fracture of Finger
Finger Fracture
Keywords: Reduction, Fracture
Lead sponsor: The Second Hospital of Qinhuangdao
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 98
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 middle proximal fractures of fingers
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

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 progrssion 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:
References:
citation: Edwards GS Jr, O'Brien ET, Heckman MM. Retrograde cross-pinning of transverse metacarpal and phalangeal fractures. Hand. 1982 Jun;14(2):141-8. doi: 10.1016/s0072-968x(82)80005-3. No abstract available.
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. doi: 10.1016/j.jhsb.2005.09.013. Epub 2005 Nov 15.
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. Epub 2012 Jun 26.