Cemented K-wire Fixation vs Open Transfixion Pinning

NCT03082872 | Completed DMC

• 1 other identifier: THHMU201763
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Closed Fracture of Finger; Finger Fracture

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 progrssion from any cause, which is assessed up to 2 years.

Study Arms (2)

Cemented K-wire Fixation

EXPERIMENTAL

Fractures were transverse (n=32), short oblique or spiral (n=5), and comminuted (n=14) fractures.

Device: Cemented K-wire; Device: Transfixion Pinning

Open Transfixion Pinning

EXPERIMENTAL

Fractures were transverse (n=28), short oblique or spiral (n=4), and comminuted (n=15) fractures.

Device: Cemented K-wire; Device: Transfixion Pinning

Interventions

Cemented K-wire DEVICE

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

Cemented K-wire Fixation; Open Transfixion Pinning

Transfixion Pinning DEVICE

Fracture of proximal phalanx was treated with transfixion pinning.

Cemented K-wire Fixation; Open Transfixion Pinning

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 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.

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;
• 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.

Sponsors & Collaborators

• The Second Hospital of Qinhuangdao: lead

Study Sites (1)

Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050051, China

Location

Related Publications (3)

• 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.

  PMID: 7117927 RESULT

• 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.

  PMID: 16293357 RESULT

• 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.

  PMID: 22883890 RESULT

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

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 middle proximal fractures of fingers

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 17, 2017
• Study Start: January 1, 2009
• Primary Completion: January 30, 2015
• Study Completion: January 30, 2015
• Last Updated: March 17, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)