CClinicalTrials.gg
Status unknownNCT03545230Updated Jun 8, 2018

Results of "Four Not Techniques" in Delayed and Nonunion Fractures of Lateral Humeral Condyle in Children

An interventional study of :Four Not Techniques" in Orthopaedic Surgery, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2018-06-08.

Sponsored by Mahidol University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
01

Study 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.

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",

  1. the surgical approach should not enter posteriorly because the blood supply of lateral condyle enter posteriorly in order to avoid cut the vessels.
  2. The dissection should not too much especially the muscle around the condyle.
  3. 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.
  4. 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.

  1. 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.
  2. 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.
  3. 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.
  4. 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

  1. The union rate
  2. The carrying angle , Baumann angle,shaft condylar angle
  3. ROM
  4. Complication of surgery such as infection,AVN of troclear etc.
02

Conditions studied

  • Orthopaedic Surgery
03

In context

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • all children less than 18 years old with delayed union and nonunion of fracture lateral humeral condyle

Exclusion criteria

Exclusion Criteria:

  • any previous surgery at the same elbow
  • refuse to participate the research
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    children who recieved "Four Not Techniques" surgery

    :Four Not Techniques"

    Procedure: :Four Not Techniques"

Interventions

  • Procedure: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.

06

What researchers measure

Primary outcomes

  1. the union rate

    the healing of the fracture in percentage

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Faculty of Medicine Siriraj Hospital Mahidol University
    Bangkok, 10700, Thailand
    • Kamolporn kaewpornsawan, M.D, Ph.D · Contact · kamolporn.kae@mahidol.ac.th · 662 4113191
    • Kamolporn kaewpornsawan, M.D, Ph.D · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03545230
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
Jun 4, 2018
Start date
Jun 10, 2018 (estimated)
Primary completion
Jun 30, 2019 (estimated)
Completion
Jun 30, 2019 (estimated)
Last update
Jun 8, 2018

Study contacts

prof.Dr.Kamolporn Kaewpornsawan, MD
Contact
kamolporn.kae@mahidol.ac.th
660814984227
Prof.Dr.Kamolporn Kaewpornsawan, MD.
principal investigator · Department of Orthopaedic Surgery,Faculty of Medicine,Siriraj Hospital,Mahidol University,Bangkok,Thailand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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