Medial Epicondyle Fracture of the HumerusNCT04531085
Treatment of Medial Epicondyle Fractures in Children and Adolescents
A study testing Operative treatment and Long arm cast in people with Medial Epicondyle Fracture of the Humerus and 7 To16 Year Old Children and Adolecents, run by Helsinki University Central Hospital at 4 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Medial Epicondyle Fracture of the Humerus, 7 To16 Year Old Children and Adolecents, More Than 2 Mm of Displacement
- What is being tested?
- Operative treatment and Long arm cast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesFinland
- Study dates
- 30 Aug 2019to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Over 2 mm displaced medial epicondyle fracture of humerus on primary AP or lateral X-ray
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Finland4 sites
HUS New Childrens Hospital
Helsinki, 00029HUS
Kuopio University Hospital
Kuopio
Oulu University Hospital
Oulu
Turku University Hospital
Turku
About this study
Official title: Multi-center Comparative Study of Operative Vs Nonoperative Treatment of Medial Epicondyle Fractures in Children and Adolescents
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.
Read the 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.
- Conditions
- Medial Epicondyle Fracture of the Humerus, 7 To16 Year Old Children and Adolecents, More Than 2 Mm of Displacement
- Being tested
- Operative treatment, Long arm cast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operative treatmentProcedure or surgery
Surgery
Long arm castProcedure or surgery
cast immobilization
| Study group | Role | What they receive |
|---|---|---|
| RCT operative | Active comparator | 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. Receives: Procedure: Operative treatment |
| RCT Non-operative | Active comparator | Non-operative treatment means upper limb immobilization with forearm in neutral pro-supination with a long arm cast for 4 weeks. Receives: Procedure: Long arm cast |
| Patient preference operative | Other | 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. Receives: Procedure: Operative treatment |
| Patient preference non-operative | Other | Non-operative treatment means upper limb immobilization with forearm in neutral pro-supination with a long arm cast for 4 weeks. Receives: Procedure: Long arm cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Disabilities of the Arm, Shoulder and Hand score questionnaire(QuickDASH)
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.
Measured: 12 months
Secondary outcomes (8)
Range of Motion (ROM) degrees difference of the elbow as compared to uninjured arm
Difference in active ROM in comparison to uninjured arm. Maximum value is 160 degrees minimum 0. Lower value indicates better outcome.
Measured: 12 months
Measurement Model for the Pediatric Quality of Life Inventory questionnaire (PedsQL)
Minimum score is 0 and maximum 100. Higher score indicates better health related quality of life.
Measured: 12 months
Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ)
Minimum score 0 maximum 10. Higher value indicates higher pain intensity.
Measured: 12 months
Cosmetic Visual Analoque Scale (CVAS)
Minimum score 0 maximum 100. Higher value indicates better cosmetic appearance
Measured: 12 months
Mayo Elbow Performance Score (MEPS)
Minimum score 0 maximum 100. Higher value indicates better performance.
Measured: 12 months
Need for additional procedures (number)
Minimum value 0, no maximum value. Lower value indicates better outcome.
Measured: 12 months
Grip strength (kg) with hand held dynamometer (jamar)
compared to standard for age kg/age
Measured: 12 months
Sensation and cold intolerance
semmes-weinstein monofilaments scored as normal or abnormal
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start30 Aug 2019
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medial Epicondyle Fracture of the HumerusStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-inferiority RCT 1:1 ratio
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petra Grahn, Helsinki University Central Hospital
- Investigators
- Petra Grahn, MD, Principal investigator, Helsinki University Hospital, New Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531085
- Sponsor's protocol ID
- HUS/1443/2019
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon request. Any requests should be sent to the principal investigator.
Publications
Grahn P, Helenius I, Hamalainen T, Kivisaari R, Nietosvaara Y, Sinikumpu JJ, Jalkanen J, Loyttyniemi E, Ahonen M; Finnish Pediatric Orthopedic Study Group Investigators. Casting vs Surgical Treatment of Children With Medial Epicondyle Fractures: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e258479. doi: 10.1001/jamanetworkopen.2025.8479.
PubMed 40327343Hamalainen T, Ahonen M, Helenius I, Jalkanen J, Lastikka M, Nietosvaara Y, Salonen A, Sinikumpu JJ, Grahn P. Cast immobilisation in situ versus open reduction and internal fixation of displaced medial epicondyle fractures in children between 7 and 16 years old. A study protocol for a randomised controlled trial. BMJ Open. 2021 May 3;11(5):e044627. doi: 10.1136/bmjopen-2020-044627.
PubMed 33941629
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Comparative Study of Operative Vs Nonoperative Treatment of Medial Epicondyle Fractures in Children and Adolescents
- ClinicalTrials.gov ID
- NCT04531085
- Acronym / sponsor ID
- HUS/1443/2019
- Conditions
- Medial Epicondyle Fracture of the Humerus, 7 To16 Year Old Children and Adolecents, More Than 2 Mm of Displacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Non-inferiority RCT 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| RCT operative | Active comparator | Procedure: Operative treatmentProcedure 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. |
| RCT Non-operative | Active comparator | Procedure: Long arm castNon-operative treatment means upper limb immobilization with forearm in neutral pro-supination with a long arm cast for 4 weeks. |
| Patient preference operative | Other | Procedure: Operative treatmentProcedure 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. |
| Patient preference non-operative | Other | Procedure: Long arm castNon-operative treatment means upper limb immobilization with forearm in neutral pro-supination with a long arm cast for 4 weeks. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Over 2 mm displaced medial epicondyle fracture of humerus on primary AP or lateral X-ray
Key exclusion criteria (6 listed)
- Ulnar nerve dysfunction
- Pathological fracture
- Open fracture
- Systemic bone disease
- Concomitant fracture or injury of the same upper limb requiring operative intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Operative treatmentSurgery | Procedure or surgery | Patient preference operative, RCT operative |
| Long arm castcast immobilization | Procedure or surgery | Patient preference non-operative, RCT Non-operative |
Primary outcome
Quick Disabilities of the Arm, Shoulder and Hand score questionnaire(QuickDASH)
Time frame: 12 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.
8 secondary outcomes
Range of Motion (ROM) degrees difference of the elbow as compared to uninjured arm
Time frame: 12 months
Measurement Model for the Pediatric Quality of Life Inventory questionnaire (PedsQL)
Time frame: 12 months
Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ)
Time frame: 12 months
Cosmetic Visual Analoque Scale (CVAS)
Time frame: 12 months
Mayo Elbow Performance Score (MEPS)
Time frame: 12 months
Need for additional procedures (number)
Time frame: 12 months
Grip strength (kg) with hand held dynamometer (jamar)
Time frame: 12 months
Sensation and cold intolerance
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 40327343Grahn P, Helenius I, Hamalainen T, Kivisaari R, Nietosvaara Y, Sinikumpu JJ, Jalkanen J, Loyttyniemi E, Ahonen M; Finnish Pediatric Orthopedic Study Group Investigators. Casting vs Surgical Treatment of Children With Medial Epicondyle Fractures: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e258479. doi: 10.1001/jamanetworkopen.2025.8479.
- Derived from this study: PubMed 33941629Hamalainen T, Ahonen M, Helenius I, Jalkanen J, Lastikka M, Nietosvaara Y, Salonen A, Sinikumpu JJ, Grahn P. Cast immobilisation in situ versus open reduction and internal fixation of displaced medial epicondyle fractures in children between 7 and 16 years old. A study protocol for a randomised controlled trial. BMJ Open. 2021 May 3;11(5):e044627. doi: 10.1136/bmjopen-2020-044627.
- Protocol publicationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be available upon request. Any requests should be sent to the principal investigator.
Related trials for Medial Epicondyle Fracture of the Humerus
RecruitingObservational study
Technique and Preliminary Results of Medial Epicondyle Fracture Fixation Using Anchors and Review of the Literature
Medial Epicondyle Fractures of the Elbow
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Grahn, MD principal investigator
Helsinki University Hospital, New Childrens Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operative treatment and Long arm cast in people with Medial Epicondyle Fracture of the Humerus and 7 To16 Year Old Children and Adolecents, run by Helsinki University Central Hospital at 4 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Disabilities of the Arm, Shoulder and Hand score questionnaire(QuickDASH) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04531085, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.