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

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.

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

Study Overview

• Status: Unknown
• Conditions: Orthopaedic Surgery
• Intervention / Treatment: Procedure: :Four Not Techniques"

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Faculty of medicine Siriraj Hospital Mahidol University
    • Contact: Kamolporn kaewpornsawan, M.D, Ph.D; Phone Number: 662 4113191; Email: kamolporn.kae@mahidol.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: children who recieved "Four Not Techniques" surgery; :Four Not Techniques"	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the union rate	the healing of the fracture in percentage	1 year

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Prof.Dr.Kamolporn Kaewpornsawan, MD., Department of Orthopaedic Surgery,Faculty of Medicine,Siriraj Hospital,Mahidol University,Bangkok,Thailand

Study record dates

Study Major Dates

• Study Start (Anticipated): June 10, 2018
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): June 8, 2018
• Last Update Submitted That Met QC Criteria: June 7, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Si 355/2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No