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Cemented K-wire Fixation vs Open Transfixion Pinning

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03082872
Enrollment
98
Registered
2017-03-17
Start date
2009-01-01
Completion date
2015-01-30
Last updated
2017-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Closed Fracture of Finger, Finger Fracture

Keywords

Reduction, Fracture

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.

Interventions

DEVICECemented K-wire

Fracture of proximal phalanx was treated with Cemented K-wire.

DEVICETransfixion Pinning

Fracture of proximal phalanx was treated with transfixion pinning.

Sponsors

The Second Hospital of Qinhuangdao
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Blinded

Intervention model description

Patients with middle proximal fractures of fingers

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Bone healingUp 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

MeasureTime frameDescription
Joint motionUp 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

Other

MeasureTime frameDescription
Patient satisfactionUp to 2 years. From date of randomization until the date of third documented progrssion from any cause, which is assessed up to 2 years.Patient self assessment based on 100-mm visual analogue scale.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026