Cemented K-wire Fixation vs Plating for Finger Fractures

NCT ID: NCT03031015

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2014-05-01

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.

Conditions

Closed Fracture of Finger; Finger Fracture Open

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cemented K-wire Fixation

The mean age of group A was 41 years (range, 18-63 years). There were 56 male and 11 female patients. The mean time from injury to operation was 5±4.53 days. Injured digits included index (n=24), long (n=19), ring (n=9), and little (n=15) fingers. Types of fractures were transversal (n=31), oblique or spiral (n=14), and comminuted (n=22) fractures. The patients were treated with Cemented K-wire Fixation.

Group Type: EXPERIMENTAL

Cemented K-wire Fixation

Intervention Type: DEVICE

Fractures were reduced and then fixed with cemented K-wires.

Plating

Intervention Type: DEVICE

Fractures were reduced and then fixed with Plate.

Plating

The mean age of group A was 39 years (range, 19-61 years). There were 51 male and 13 female patients. The mean time from injury to operation was 6±5.53 days. Injured digits included index (n=21), long (n=17), ring (n=10), and little (n=16) fingers. Types of fractures were transversal (n=34), oblique or spiral (n=11), and comminuted (n=19) fractures.The patients were treated with Plating.

Group Type: ACTIVE_COMPARATOR

Cemented K-wire Fixation

Intervention Type: DEVICE

Fractures were reduced and then fixed with cemented K-wires.

Plating

Intervention Type: DEVICE

Fractures were reduced and then fixed with Plate.

Interventions

Cemented K-wire Fixation

Fractures were reduced and then fixed with cemented K-wires.

Intervention Type: DEVICE

Plating

Fractures were reduced and then fixed with Plate.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Qinhuangdao

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xu Zhang, MD

Role: STUDY_CHAIR

Third Hospital of Hebei Medical University

Xinzhong Shao, MD

Role: PRINCIPAL_INVESTIGATOR

Third Hospital of Hebei Medical University

Locations

Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 27702779 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27056278 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26699692 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30408421 (View on PubMed)

Other Identifiers

THHMU201701

Identifier Type: -

Identifier Source: org_study_id