Cemented K-wire Fixation vs Plating for Finger Fractures

NCT03031015 | Completed DMC

• 1 other identifier: THHMU201701
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Closed Fracture of Finger; Finger Fracture Open

Keywords

Reduction, Fracture

Outcome Measures

Primary Outcomes (1)

• Bone healing

  Time of 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.

Secondary Outcomes (1)

• 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.

Other Outcomes (1)

• 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.

Study Arms (2)

Cemented K-wire Fixation

EXPERIMENTAL

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.

Device: Cemented K-wire Fixation; Device: Plating

Plating

ACTIVE COMPARATOR

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.

Device: Cemented K-wire Fixation; Device: Plating

Interventions

Cemented K-wire Fixation DEVICE

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

Cemented K-wire Fixation; Plating

Plating DEVICE

Fractures were reduced and then fixed with Plate.

Cemented K-wire Fixation; Plating

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Qinhuangdao: lead

Study Sites (1)

Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050051, China

Location

Related Publications (4)

• 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.

  PMID: 27702779 RESULT

• 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.

  PMID: 27056278 RESULT

• 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.

  PMID: 26699692 RESULT

• 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.

  PMID: 30408421 DERIVED

MeSH Terms

Conditions

Fractures, Bone

Interventions

Electroplating

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electrolysis; Electrochemical Techniques; Investigative Techniques

Study Officials

• Xu Zhang, MD

  Third Hospital of Hebei Medical University

  STUDY CHAIR

• Xinzhong Shao, MD

  Third Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with proximal phalangeal fractures of fingers.

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 25, 2017
• Study Start: January 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: January 25, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)