Orthopaedic SurgeryNCT03545230
Results of "Four Not Techniques" in Delayed and Nonunion Fractures of Lateral Humeral Condyle in Children
A study testing :Four Not Techniques" in people with Orthopaedic Surgery, run by Mahidol University at 1 site in Thailand.
Trial summary
Fracture of lateral humeral condyle in children is not uncommon.The nonunion means no healing of the fracture after 3 months from the injury.Delayed union means no healing from 6 weels to less than 3 months after injury. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Orthopaedic Surgery
- What is being tested?
- :Four Not Techniques"
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 10 Jun 2018to 30 Jun 2019
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- all children less than 18 years old with delayed union and nonunion of fracture lateral humeral condyle
Who cannot join
- any previous surgery at the same elbow
- refuse to participate the research
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital Mahidol University
Bangkok, 10700
Kamolporn kaewpornsawan, M.D, Ph.D, 662 4113191, kamolporn.kae@mahidol.ac.th
Kamolporn kaewpornsawan, M.D, Ph.D
About this study
Official title: Four "Not" Technique in Delayed and Nonunion of Lateral Humeral Condyle Fracture in
Fracture of lateral humeral condyle in children is not uncommon.The nonunion means no healing of the fracture after 3 months from the injury.Delayed union means no healing from 6 weels to less than 3 months after injury.
The treatment is difficult even surgery because of lack of blood supply of lateral condyle,unstability from muscle force and the articular fluid inhibition of union.
Read more
The author try to improve the healing of the fracture after surgery by "4 not techniques",
- the surgical approach should not enter posteriorly because the blood supply of lateral condyle enter posteriorly in order to avoid cut the vessels.
- The dissection should not too much especially the muscle around the condyle.
- It is not necessary to perfectly reduced the fracture after nonunion to avoid too much dissection the muscle and allow only healing of the fragment.
- Bone graft is not necessary. The author wants to know the results after perform "4 not technique" in delayed union and nonunion of lateral humeral condyle fracture
Read the detailed description
All children with delayed union or nonunion fracture lateral humeral condyle fractures will be inclued in the study.
The children who received the previous surgery of the same elbow will be excluded.
After full explanation and discussion to the children and parents.The surgery in "4 not technique" will be performed.
- the lateral approach of the affected elbow and enter the fracture anteriorly. The approach should not enter posteriorly because the blood supply of lateral condyle enter posteriorly in order to avoid cut the vessels.
- The dissection should not too much especially the muscle around the condyle. The nonunon fragment will be cleaned,washed and made until the healthy bone surface of fracture appear in both side of fracture.
- It is not necessary to perfectly reduced the fracture after nonunion to avoid too much dissection the muscle and allow only healing of the fragment.The fixation by K-wires or screw in older children until the fragment is stable enough.
- Bone graft is not necessary but in valgus deformity the correctuve osteotomy should be performed to correct the valgus.
The skin is closed,the long arm cast is put and change in 2 weeks interval until bone union.
The measurement will be
- The union rate
- The carrying angle , Baumann angle,shaft condylar angle
- ROM
- Complication of surgery such as infection,AVN of troclear etc.
- Conditions
- Orthopaedic Surgery
- Being tested
- :Four Not Techniques"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
:Four Not Techniques"Procedure or surgery
:Four Not Techniques"
- Not enter posteriorly
- Not too much dissection the muscle around the lateral condyle during surgery
- Not perfect anatomical reduction
- Not using bone graft.
| Study group | Role | What they receive |
|---|---|---|
| children who recieved "Four Not Techniques" surgery | Experimental | :Four Not Techniques" Receives: Procedure: :Four Not Techniques" |
What is being measured
The primary outcome is the main question the study is designed to answer.
the union rate
the healing of the fracture in percentage
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start10 Jun 2018 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopaedic SurgeryStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- all childre with delayed union and nonunion lateral humeral condyle will be included. After informed consent and full explanation.The Four Not Techniques""will be done
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof.Dr.Kamolporn Kaewpornsawan, MD., Principal investigator, Department of Orthopaedic Surgery,Faculty of Medicine,Siriraj Hospital,Mahidol University,Bangkok,Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545230
- Sponsor's protocol ID
- Si 355/2016
- Status last verified
- Jun 2018
- First submitted
- 22 May 2018
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four "Not" Technique in Delayed and Nonunion of Lateral Humeral Condyle Fracture in
- ClinicalTrials.gov ID
- NCT03545230
- Acronym / sponsor ID
- Si 355/2016
- Conditions
- Orthopaedic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 10 Jun 2018 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 4 Jun 2018 (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.
Fracture of lateral humeral condyle in children is not uncommon.The nonunion means no healing of the fracture after 3 months from the injury.Delayed union means no healing from 6 weels to less than 3 months after injury.
The treatment is difficult even surgery because of lack of blood supply of lateral condyle,unstability from muscle force and the articular fluid inhibition of union.
The author try to improve the healing of the fracture after surgery by "4 not techniques",
- the surgical approach should not enter posteriorly because the blood supply of lateral condyle enter posteriorly in order to avoid cut the vessels.
- The dissection should not too much especially the muscle around the condyle.
- It is not necessary to perfectly reduced the fracture after nonunion to avoid too much dissection the muscle and allow only healing of the fragment.
- Bone graft is not necessary. The author wants to know the results after perform "4 not technique" in delayed union and nonunion of lateral humeral condyle fracture
Detailed description
All children with delayed union or nonunion fracture lateral humeral condyle fractures will be inclued in the study.
The children who received the previous surgery of the same elbow will be excluded.
After full explanation and discussion to the children and parents.The surgery in "4 not technique" will be performed.
- the lateral approach of the affected elbow and enter the fracture anteriorly. The approach should not enter posteriorly because the blood supply of lateral condyle enter posteriorly in order to avoid cut the vessels.
- The dissection should not too much especially the muscle around the condyle. The nonunon fragment will be cleaned,washed and made until the healthy bone surface of fracture appear in both side of fracture.
- It is not necessary to perfectly reduced the fracture after nonunion to avoid too much dissection the muscle and allow only healing of the fragment.The fixation by K-wires or screw in older children until the fragment is stable enough.
- Bone graft is not necessary but in valgus deformity the correctuve osteotomy should be performed to correct the valgus.
The skin is closed,the long arm cast is put and change in 2 weeks interval until bone union.
The measurement will be
- The union rate
- The carrying angle , Baumann angle,shaft condylar angle
- ROM
- Complication of surgery such as infection,AVN of troclear etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all childre with delayed union and nonunion lateral humeral condyle will be included. After informed consent and full explanation.The Four Not Techniques""will be done
| Arm | Type | Receives |
|---|---|---|
| children who recieved "Four Not Techniques" surgery | Experimental | Procedure: :Four Not Techniques":Four Not Techniques" |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all children less than 18 years old with delayed union and nonunion of fracture lateral humeral condyle
Key exclusion criteria (2 listed)
- any previous surgery at the same elbow
- refuse to participate the research
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 |
|---|---|---|
| :Four Not Techniques":Four Not Techniques" 1. Not enter posteriorly 2. Not too much dissection the muscle around the lateral condyle during surgery 3. Not perfect anatomical reduction 4. Not using bone graft. | Procedure or surgery | children who recieved "Four Not Techniques" surgery |
Primary outcome
the union rate
Time frame: 1 year
the healing of the fracture in percentage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
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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.
Prof.Dr.Kamolporn Kaewpornsawan, MD. principal investigator
Department of Orthopaedic Surgery,Faculty of Medicine,Siriraj Hospital,Mahidol University,Bangkok,Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing :Four Not Techniques" in people with Orthopaedic Surgery, run by Mahidol University at 1 site in Thailand.
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 2 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: status not confirmed, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact prof.Dr.Kamolporn Kaewpornsawan, MD (660814984227, kamolporn.kae@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the union rate (time frame: 1 year). 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 8 Jun 2018.