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Leg Length Discrepancy Techniques for Leg Length Discrepancy

N/A

Recruiting

Led By Emily R Dodwell, MD MPH FRCSC

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Must not have

Patients undergoing additional orthopedic procedures at time of epiphysiodesis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years (end of study)

Awards & highlights

Study Summary

This trial is testing two different methods for correcting leg length discrepancy, to see which one is more successful. The primary outcome is failed epiphysiodesis, which is defined as one or more of the following: development of angular deformity > 5°, revision epiphysiodesis, or growth inhibition < 70% of expected.

Eligible Conditions

Leg Length Discrepancy

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

You are having other orthopedic procedures done at the same time as the epiphysiodesis procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years (end of study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years (end of study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years (end of study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Failure of Epiphysiodesis

Secondary outcome measures

Change in Physeal Growth

Complications

Days Until Return to Sports

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Percutaneous Screw EpiphysiodesisExperimental Treatment2 Interventions

In the distal femur, guide wires will be placed in an antegrade fashion, with an 8 mm skin incision proximal to the physis both medially and laterally. The guide wire will be placed with the medial wire crossing the physis at the junction of the middle and medial third of the physis. The lateral guide wire will cross the physis at the junction of the lateral and middle third of the physis. The wires will extend into the epiphysis, but will not enter the joint. The guide wires will be over drilled with a 5 mm drill, and 7.3 mm fully threaded cannulated screws will be placed across the growth plate. For tibias, screw placement will be retrograde, with 8 mm incisions made medially and laterally distal to the physis, with guide wires aiming proximally.

Group II: Percutaneous Drill EpiphysiodesisActive Control2 Interventions

A 5 mm incision will be made centered over the physis both medially and laterally. A 4.5 mm drill will be passed repeatedly across the physis in a divergent manner. Curettes will then be used to further remove and disrupt the growth plate. Fluoroscopy will be used throughout to ensure proper passage of the drill and curettes. Omnipaque dye will then be inserted to confirm ablation of the physis.

0 / 1Eligibility criteria met