Back to results

Cemented K-wire Fixation vs Plating for Finger Fractures (CKFPFF)

Primary Purpose

Closed Fracture of Finger, Finger Fracture Open

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Cemented K-wire Fixation

Plating

About this trial

This is an interventional treatment trial for Closed Fracture of Finger focused on measuring Reduction, Fracture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Third Hospital of Hebei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cemented K-wire Fixation

Plating

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Bone healing

Time of bone healing.

Secondary Outcome Measures

Joint motion

Range of motion of MCP, PIP, and DIP joints.

Full Information

NCT ID

NCT03031015

First Posted

January 19, 2017

Last Updated

January 21, 2017

Sponsor

The Second Hospital of Qinhuangdao

1. Study Identification

Unique Protocol Identification Number

NCT03031015

Brief Title

Cemented K-wire Fixation vs Plating for Finger Fractures

Acronym

CKFPFF

Official Title

Randomized Comparison of Cemented K-wire Fixation and Plating of Shaft Fractures of Proximal Phalanges

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

January 1, 2011 (Actual)

Primary Completion Date

May 1, 2014 (Actual)

Study Completion Date

May 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Second Hospital of Qinhuangdao

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Closed Fracture of Finger, Finger Fracture Open

Keywords

Reduction, Fracture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Patients with proximal phalangeal fractures of fingers.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

blinded

Allocation

Randomized

Enrollment

131 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cemented K-wire Fixation

Arm Type

Experimental

Arm Description

Arm Title

Plating

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Cemented K-wire Fixation

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Plating

Intervention Description

Fractures were reduced and then fixed with Plate.

Primary Outcome Measure Information:

Title

Bone healing

Description

Time of bone healing.

Time Frame

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 Outcome Measure Information:

Title

Joint motion

Description

Range of motion of MCP, PIP, and DIP joints.

Time Frame

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 Pre-specified Outcome Measures:

Title

Patient satisfaction.

Description

Patient self assessment based on 100-mm visual analogue scale.

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xu Zhang, MD

Organizational Affiliation

Third Hospital of Hebei Medical University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Xinzhong Shao, MD

Organizational Affiliation

Third Hospital of Hebei Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Third Hospital of Hebei Medical University

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050051

Country

China

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plan to share the IPD data.

Citations:

PubMed Identifier

27702779

Citation

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.

Results Reference

result

PubMed Identifier

27056278

Citation

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. Erratum In: J Hand Surg Eur Vol. 2016 Sep;41(7):NP1.

Results Reference

result

PubMed Identifier

26699692

Citation

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.

Results Reference

result

PubMed Identifier

30408421

Citation

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.

Results Reference

derived

Learn more about this trial

Cemented K-wire Fixation vs Plating for Finger Fractures

We'll reach out to this number within 24 hrs