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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031015
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
The Second Hospital of Qinhuangdao

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.

Condition or disease Intervention/treatment Phase
Closed Fracture of Finger Finger Fracture Open Device: Cemented K-wire Fixation Device: Plating Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients with proximal phalangeal fractures of fingers.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: blinded
Primary Purpose: Treatment
Official Title: Randomized Comparison of Cemented K-wire Fixation and Plating of Shaft Fractures of Proximal Phalanges
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : May 1, 2014
Actual Study Completion Date : May 1, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: 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.
Device: Cemented K-wire Fixation
Fractures were reduced and then fixed with cemented K-wires.

Device: Plating
Fractures were reduced and then fixed with Plate.

Active Comparator: 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.
Device: Cemented K-wire Fixation
Fractures were reduced and then fixed with cemented K-wires.

Device: Plating
Fractures were reduced and then fixed with Plate.




Primary Outcome Measures :
  1. 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. ]
    Time of bone healing.


Secondary Outcome Measures :
  1. Joint motion [ 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. ]
    Range of motion of MCP, PIP, and DIP joints.


Other Outcome Measures:
  1. Patient satisfaction. [ 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. ]
    Patient self assessment based on 100-mm visual analogue scale.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031015


Locations
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China, Hebei
Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050051
Sponsors and Collaborators
The Second Hospital of Qinhuangdao
Investigators
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Study Chair: Xu Zhang, MD Third Hospital of Hebei Medical University
Principal Investigator: Xinzhong Shao, MD Third Hospital of Hebei Medical University
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Second Hospital of Qinhuangdao
ClinicalTrials.gov Identifier: NCT03031015    
Other Study ID Numbers: THHMU201701
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share the IPD data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Second Hospital of Qinhuangdao:
Reduction, Fracture
Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Closed
Wounds and Injuries