Fracture ArmNCT03112447
Treatment of Medial Humeral Epicondyle Fractures in Children With Absorbable Cartilage Nails
A study testing absorbable cartilage nail and traditional Kirschner wires in people with Fracture Arm, run by Children's Hospital of Chongqing Medical University.
Trial summary
To compare surgical outcomes from medial epicondyle fracture fixation with absorbable cartilage nails to those from traditional Kirschner wire fixation. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Fracture Arm
- What is being tested?
- absorbable cartilage nail and traditional Kirschner wires
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2007to 1 Aug 2012
- 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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- fractures with more than 2 mm of displacement were treated with cast immobilization
Who cannot join
- fractures with less than 2 mm of displacement were treated with cast immobilization
About this study
To compare surgical outcomes from medial epicondyle fracture fixation with absorbable cartilage nails to those from traditional Kirschner wire fixation.
Read the detailed description
From August 2007 to January 2012, 32 patients undergoing surgery for medial humeral epicondyle fractures in our hospital were randomized into group A (traditional Kirschner wire) or group B (absorbable cartilage nail). The same surgical team performed the operations, and patients were followed for over a year. Group A had open reduction with K-wire fixation, and group B was fixed with absorbable cartilage nails. The Bede scoring system was used to evaluate elbow function at follow-up.
- Conditions
- Fracture Arm
- Being tested
- absorbable cartilage nail, traditional Kirschner wires
- Keywords
- medial epicondyle humerus, absorbable cartilage nail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
absorbable cartilage nailProcedure or surgery
The experiment group patients were fixed with absorbable cartilage nails
traditional Kirschner wiresProcedure or surgery
The control group were fixed with traditional Kirschner wires
| Study group | Role | What they receive |
|---|---|---|
| absorbable cartilage nail Group | Experimental | 10 males and 7 females, ages 7-15 years (average, 11.8), and 3 patients with elbow dislocation, the fractures were fixed by absorbable cartilage nail Receives: Procedure: absorbable cartilage nail |
| traditional Kirschner wire Group | Active comparator | 10 males and 5 females, ages 8-14 years (average, 12.6), and 4 patients with elbow dislocation, the fractures were fixed by traditional Kirschner wires Receives: Procedure: traditional Kirschner wires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain Intensity assessed with the Bede Scoring System
Measured: on 12th month
Elbow Motion
Elbow Motion assessed in degrees
Measured: on 12th month
Stability
Stability assessed using the following scoring system: Stable, Moderate Instability, Grossly Unstable.
Measured: on 12th month
Elbow Function evaluation
A specific physician check the patients and ask them to perform the following activity.(comb hair,eat;perform hygiene;don shirt;don shoe)
Measured: on 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start1 Aug 2007
- Primary completion1 Aug 2012
- Study completion1 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture ArmStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoxin Nan, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112447
- Sponsor's protocol ID
- CHChongqingMU2016
- Status last verified
- Apr 2017
- First submitted
- 6 Mar 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Medial Humeral Epicondyle Fractures in Children With Absorbable Cartilage Nails
- ClinicalTrials.gov ID
- NCT03112447
- Acronym / sponsor ID
- CHChongqingMU2016
- Conditions
- Fracture Arm
- Keywords
- medial epicondyle humerus, absorbable cartilage nail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2007 (actual)
- Primary completion
- 1 Aug 2012 (actual)
- Study completion
- 1 Aug 2012 (actual)
- First posted
- 13 Apr 2017 (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.
To compare surgical outcomes from medial epicondyle fracture fixation with absorbable cartilage nails to those from traditional Kirschner wire fixation.
Detailed description
From August 2007 to January 2012, 32 patients undergoing surgery for medial humeral epicondyle fractures in our hospital were randomized into group A (traditional Kirschner wire) or group B (absorbable cartilage nail). The same surgical team performed the operations, and patients were followed for over a year. Group A had open reduction with K-wire fixation, and group B was fixed with absorbable cartilage nails. The Bede scoring system was used to evaluate elbow function at follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| absorbable cartilage nail Group | Experimental | Procedure: absorbable cartilage nail10 males and 7 females, ages 7-15 years (average, 11.8), and 3 patients with elbow dislocation, the fractures were fixed by absorbable cartilage nail |
| traditional Kirschner wire Group | Active comparator | Procedure: traditional Kirschner wires10 males and 5 females, ages 8-14 years (average, 12.6), and 4 patients with elbow dislocation, the fractures were fixed by traditional Kirschner wires |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- fractures with more than 2 mm of displacement were treated with cast immobilization
Key exclusion criteria (1 listed)
- fractures with less than 2 mm of displacement were treated with cast immobilization
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 |
|---|---|---|
| absorbable cartilage nailThe experiment group patients were fixed with absorbable cartilage nails | Procedure or surgery | absorbable cartilage nail Group |
| traditional Kirschner wiresThe control group were fixed with traditional Kirschner wires | Procedure or surgery | traditional Kirschner wire Group |
Primary outcome
Pain Intensity
Time frame: on 12th month
Pain Intensity assessed with the Bede Scoring System
Elbow Motion
Time frame: on 12th month
Elbow Motion assessed in degrees
Stability
Time frame: on 12th month
Stability assessed using the following scoring system: Stable, Moderate Instability, Grossly Unstable.
Elbow Function evaluation
Time frame: on 12th month
A specific physician check the patients and ask them to perform the following activity.(comb hair,eat;perform hygiene;don shirt;don shoe)
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 13 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Fracture Arm
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Active, not recruiting
Treatment of Olecranon Fractures in the Elderly
Olecranon Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing absorbable cartilage nail and traditional Kirschner wires in people with Fracture Arm, run by Children's Hospital of Chongqing Medical University.
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 1 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 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain Intensity (time frame: on 12th month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2017.