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

NCT03545230 | Unknown

• 1 other identifier: Si 355/2016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.The dissection should not too much especially the muscle around the condyle.
3. 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. 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

Conditions

Orthopaedic Surgery

Outcome Measures

Primary Outcomes (1)

• the union rate

  the healing of the fracture in percentage

  1 year

Study Arms (1)

children who recieved "Four Not Techniques" surgery

EXPERIMENTAL

:Four Not Techniques"

Procedure: :Four Not Techniques"

Interventions

:Four Not Techniques" PROCEDURE

: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.

children who recieved "Four Not Techniques" surgery

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital Mahidol University

Bangkok, 10700, Thailand

RECRUITING

Study Officials

• Prof.Dr.Kamolporn Kaewpornsawan, MD.

  Department of Orthopaedic Surgery,Faculty of Medicine,Siriraj Hospital,Mahidol University,Bangkok,Thailand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

prof.Dr.Kamolporn Kaewpornsawan, MD

CONTACT

660814984227; kamolporn.kae@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 4, 2018
• Study Start: June 10, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: June 8, 2018

Record last verified: 2018-06

Locations

TH (1)