PEDS Trial: Percutaneous Epiphysiodesis, Drill Versus Screws for Leg Length Discrepancy a Randomized Clinical Trial

Status: Terminated
Location: See all (3) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a randomized clinical trial of epiphysiodesis techniques: percutaneous transphyseal screw epiphysiodesis versus percutaneous drill epiphysiodesis for the correction of leg length discrepancy. Failed epiphysiodesis was selected as the primary outcome. Failed epiphysiodesis was defined as one or more of the following: development of angular deformity \> 5°, revision epiphysiodesis, or growth inhibition \< 70% of expected. EOS, low dose biplanar X-Ray, will be used to make all length measurements. Secondary outcomes assess mean growth at the physis following epiphysiodesis, in the subset of patients with bead implantation, fluoroscopy and operative times, length of stay, return to full weight bearing, as well as functional and quality of life outcomes. The following outcome scales will be used to measure pain (VAS), quality of life (PROMIS Pediatric Pain Interference Scale), and function (PROMIS Pediatric Mobility Scale, Pedi-FABS, and UCLA Activity Score). Each of these scales has been validated for use in children (Beyer, Denyes, \& Villarruel, 1992; DeWitt et al., 2011; Fabricant et al., 2013; Novais et al., 2014; Varni et al., 2010a). We will also determine the cost associated with each technique and perform a cost-effectiveness analysis to establish which technique is preferred from a societal perspective.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 18
Healthy Volunteers: f
View:

• Open growth plates

• Skeletally immature requiring isolated complete epiphysiodesis of the distal femur and/or proximal tibia

• At least one year of predicted growth remaining

• Less than 18 years of age

• Predicted limb length discrepancy 2-7 cm

Locations
United States
Massachusetts
Boston Children's Hospital
Boston
New York
Hospital for Special Surgery
New York
Other Locations
Canada
Hospital for Sick Children
Toronto
Time Frame
Start Date: 2015-06
Completion Date: 2023-12
Participants
Target number of participants: 170
Treatments
Active_comparator: Percutaneous Drill Epiphysiodesis
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.
Experimental: Percutaneous Screw Epiphysiodesis
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.
Sponsors
Leads: Hospital for Special Surgery, New York
Collaborators: Boston Children's Hospital, The Hospital for Sick Children

This content was sourced from clinicaltrials.gov