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

Orthopaedic Surgery Clinical Trial

Official title:

Four "Not" Technique in Delayed and Nonunion of Lateral Humeral Condyle Fracture in

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03545230
• Other study ID #: Si 355/2016
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: June 2018
• Source: Mahidol University
• Contact: prof.Dr.Kamolporn Kaewpornsawan, MD
• Phone: 660814984227
• Email: kamolporn.kae[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• any previous surgery at the same elbow

• refuse to participate the research

Related Conditions & MeSH terms

• Orthopaedic Surgery

Intervention

Procedure:
• :Four Not Techniques"
: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.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the union rate	the healing of the fracture in percentage	1 year