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Treatment of Medial Epicondyle Fractures in Children and Adolescents

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ClinicalTrials.gov Identifier: NCT04531085
Recruitment Status : Not yet recruiting
First Posted : August 28, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Petra Grahn, Helsinki University Central Hospital

Brief Summary:
Cast immobilization in situ versus open reduction and internal fixation of displaced medial epicondyle fractures in children between 7 and 16 years old. A non-inferiority randomized controlled trial.

Condition or disease Intervention/treatment Phase
Elbow Fracture Procedure: Operative treatment Procedure: Long arm cast Not Applicable

Detailed Description:
This is a multicenter, controlled, prospective, randomized non-inferiority study comparing operative treatment to non-operative treatment of over 3 mm dislocated pediatric medial epicondyle fractures without joint incarceration or ulnar nerve dysfunction. A total of 120 patients will be randomized in 1:1 ratio to either operative or non-operative treatment. The study will have a parallel non-randomized patient preference arm. Non-operative treatment will be upper limb immobilization with long arm cast for 4 weeks. Operative treatment will be open reduction and internal fixation (ORIF). Data is collected at baseline and at each follow-up up to 2 years. Quick-DASH is used as primary outcome measure. Secondary outcomes are patient reported pain, differences in range of motion, PedsQL Life inventory questionnaire as well as Mayo elbow preformance score.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-inferiority RCT 1:1 ratio
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-center Comparative Study of Operative vs Nonoperative Treatment of Medial Epicondyle Fractures in Children and Adolescents
Estimated Study Start Date : August 30, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Active Comparator: RCT operative
Procedure of preference is open reduction and internal fixation (ORIF) with cannulated non-resolvable 4.0mm screw with or without washer. If the fracture fragment is too small or fragmented for screw fixation 1.6mm - 1.8mm Kirshner-wires and/or bone anchor are used. Long arm cast for 4 weeks.
Procedure: Operative treatment
Surgery

Active Comparator: RCT Non-operative
Non-operative treatment means upper limb immobilization with forearm in neutral pro-supination with a long arm cast for 4 weeks.
Procedure: Long arm cast
cast immobilization

Patient preference operative
Procedure of preference is open reduction and internal fixation (ORIF) with cannulated non-resolvable 4.0mm screw with or without washer. If the fracture fragment is too small or fragmented for screw fixation 1.6mm - 1.8mm Kirshner-wires and/or bone anchor are used. Long arm cast for 4 weeks.
Procedure: Operative treatment
Surgery

Patient preference non-operative
Non-operative treatment means upper limb immobilization with forearm in neutral pro-supination with a long arm cast for 4 weeks.
Procedure: Long arm cast
cast immobilization




Primary Outcome Measures :
  1. Quick Disabilities of the Arm, Shoulder and Hand score (QuickDASH) [ Time Frame: 24 months ]
    Minimum value is 0 and maximum 100. Higher value indicates worse function. Statistically significant difference in QuickDASH score is 6.8 (18) at 12 months FU.


Secondary Outcome Measures :
  1. Range of Motion (ROM) difference of the elbow as compared to uninjured arm [ Time Frame: 24 months ]
    Difference in active ROM in comparison to uninjured arm. Maximum value is 180, minimum 0. Lower value indicates better outcome.

  2. Measurement Model for the Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: 24 months ]
    Minimum value is 0 and maximum value is 100. Higher score indicates better health related quality of life.

  3. Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ) [ Time Frame: 24 months ]
    Minimum value 0 maximum value 10. Higher value indicates higher pain intensity

  4. Cosmetic Visual Analoque Scale (CVAS) [ Time Frame: 24 months ]
    Minimum value 0 maximum value 100. Higher value indicates better cosmetic appearance

  5. Mayo Elbow Performance Score (MEPS) [ Time Frame: 24 months ]
    Minimum value 0 maximum value 100. Higher value indicates better performance.

  6. Need for additional procedures. [ Time Frame: 24 months ]
    Minimum value 0 no maximum value. Lower value indicates better outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Diagnosis of displaced (over 3 mm) medial epicondyle fracture of humerus

Exclusion Criteria:

  • Ulnar nerve dysfunction
  • Pathological fracture
  • Open fracture
  • Systemic bone disease
  • Concomitant fracture or injury of the same upper limb requiring operative intervention
  • Other disease preventing participation in full follow-up regime or range of motion exercises
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Petra Grahn, Principal Investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT04531085    
Other Study ID Numbers: HUS/1443/2019
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries