Closed Fracture of Finger, Finger Fracture Open
Conditions
Keywords
Reduction, Fracture
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.
Interventions
DEVICECemented K-wire Fixation
Fractures were reduced and then fixed with cemented K-wires.
DEVICEPlating
Fractures were reduced and then fixed with Plate.
Sponsors
The Second Hospital of Qinhuangdao
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 proximal phalangeal 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Time of bone healing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Joint motion | 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. | Range of motion of MCP, PIP, and DIP joints. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction. | 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. | Patient self assessment based on 100-mm visual analogue scale. |
Countries
China
Outcome results
None listed