A Randomized Controlled Trial of Leg Length Discrepancy Techniques

March 15, 2023 updated by: Hospital for Special Surgery, New York

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

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.

Study Overview

Detailed Description

Drill and screw epiphysiodesis are the two most common techniques for surgical correction of predicted limb length discrepancies 2-5cm. Both procedures require minimal incisions, less than 1cm, (Canale & Christian, 1990; Metaizeau et al., 1998). Previous studies have demonstrated that both drill and screw epiphysiodesis result in improved outcomes compared to open techniques (Alzahrani, Behairy, Alhossan, Arab, & Alammari, 2003; Canale & Christian, 1990). Moreover, alternative approaches such as medial and lateral 8 plates may not sufficiently tether growth, or cause peripheral but not central growth arrest (Stewart et al., 2013). We selected drill vs. screw epiphysiodesis as the two treatment groups as they are both minimally invasive, relatively effective, in common usage, and are thought to differ in costs and other characteristics.

Although outcomes of drill and screw epiphysiodesis exist{{10 Campens,C. 2010; 11 Ghanem,I. 2011}} , the assessments are retrospective non-randomized series, which may be at risk for selection bias, and may not adequately capture all of the outcomes of interest, depending on what data is routinely collected and documented in the medical chart. To our knowledge, no prospective randomized comparison of epiphysiodesis techniques and clinical outcomes has been published accurately assessing how effective each technique is in disabling growth at the physis, or taking into account patient-centered outcomes or cost. Operative measures such as the surgical time and radiation exposure from intra-operative fluoroscopy have not previously been compared. Patient-centered outcomes such as level of pain, activity, and function by measures such PROMIS and Ped-FABS, have not been previously assessed in this population. The proposed research study aims to fill this gap.

This study was designed as a multicenter randomized trial to answer an important clinical question and to do so with a clearly defined objective and validated outcomes. This trial can be executed on a relatively small budget with simple outcome measures, and recruitment of a moderate number of patients at each of a few centers well equipped for research. By involving multiple surgeons and patients from various geographies, we improve the generalizability of this study. Our institution and collaborating institutions have been successful in completing randomized clinical trials in the past. This study will answer a clinical question that is important and current, providing orthopedic surgeons with an evidence-based identification of the ideal technique for treating predicted limb length discrepancies 2-7cm.

This study will also be the first to accurately measure mean growth following both epiphysiodesis techniques, through implantation of tantalum beads in consenting participants. These beads will provide stationary landmarks by which growth can be measured directly, and not inferred. Previous methods of judging epiphysiodesis success have primarily relied on assessing efficacy by estimating growth inhibition through calculation. Tantalum beads have been successfully used in adults and children (Lauge-Pedersen,H. 2006), and although it requires implantation of small radio-opaque beads, it is considered the gold standard when making detailed radiographic measures, and the optimal technique for physeal growth measurements.(Lauge-Pedersen,H. 2006)(Haugan,K. 2012). Over 300 000 beads have been inserted in vivo without significant complications.

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Emily R Dodwell, MD MPH FRCSC
  • Phone Number: 212-606-1451
  • Email: dodwelle@hss.edu

Study Contact Backup

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Not yet recruiting
        • Hospital for Sick Children
        • Contact:
        • Principal Investigator:
          • Martin Gargan, MD FRCSC
        • Sub-Investigator:
          • James G Wright, MD MPH FRCSC
        • Sub-Investigator:
          • Simon Kelley, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Sub-Investigator:
          • Stephen Lyman, PhD
        • Contact:
          • Emily Dodwell, MD MPH FRCSC
          • Phone Number: 212-606-1451
          • Email: dodwelle@hss.edu
        • Contact:
        • Principal Investigator:
          • Emily R Dodwell, MD MPH FRCSC
        • Sub-Investigator:
          • Roger F Widmann, MD
        • Sub-Investigator:
          • Jo Hannafin, MD PhD
        • Sub-Investigator:
          • Robert Marx, MD
        • Sub-Investigator:
          • Douglas Mintz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients undergoing additional orthopedic procedures at time of epiphysiodesis
  • Metabolic bone disease or "sick physis" syndrome, that may cause bone to grow in an unpredictable manner.
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
To measure growth at physis, four tantalum beads will be implanted per physis at baseline and take radiostereometric analysis measurements at all follow up timepoints. Tantalum beads have been used to make detailed three dimensional radiographic measurements in orthopedic and other specialties
Other Names:
  • RSA Biomedical.
  • One (1) UmRSA® Injectors Conventional design, Mussle loaded
  • Robust design, Easy to clean and sterilize, Modular design
  • (for Tantalum Markers diameter 0.8 or1.0mm)
  • 500 RSA ®Tantalum Markers diameter 0.8mm or 1.0mm
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.
To measure growth at physis, four tantalum beads will be implanted per physis at baseline and take radiostereometric analysis measurements at all follow up timepoints. Tantalum beads have been used to make detailed three dimensional radiographic measurements in orthopedic and other specialties
Other Names:
  • RSA Biomedical.
  • One (1) UmRSA® Injectors Conventional design, Mussle loaded
  • Robust design, Easy to clean and sterilize, Modular design
  • (for Tantalum Markers diameter 0.8 or1.0mm)
  • 500 RSA ®Tantalum Markers diameter 0.8mm or 1.0mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure of Epiphysiodesis
Time Frame: 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
development of angular deformity > 5°, revision epiphysiodesis, or growth inhibition < 70% of expected
2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physeal Growth
Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Distance between tantalum beads.
Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Time to Baseline Pain
Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Visual Analog Scale
Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Quality of Life
Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
PROMIS Pain Interference and Mobility
Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Length of Hospital Stay
Time Frame: An expected average of 2 days
participants will be followed for the duration of hospital stay (discharge date - admission date)
An expected average of 2 days
Time to full weight-bearing
Time Frame: 2- 6 weeks
Documenting the number of days until patient could weight-bear without using devices as crutches or wheelchairs.
2- 6 weeks
Need for Splint or Cast
Time Frame: 2- 6 weeks
Documenting days worn.
2- 6 weeks
Days Until Return to Sports
Time Frame: 2-6 weeks
Documenting how many days elapsed before the patient returned to sports. This information will be recorded in a post-operative pain and function diary. Return to sports is typically surgeon driven, but timing for return to sports is not standardized in clinical practice. In the current study patients will be allowed to return to sports when pain free, no longer limping and strength is equivalent to the non-operative side
2-6 weeks
Need for Secondary Surgery
Time Frame: 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Assessed in follow up clinical visits and documented in clinical records
2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Physical Activity Level
Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Pediatric activity scale assessment measured by HSS Pedi-FABS.
Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Physical Activity Level
Time Frame: Baseline, 2-6 weeks, 6 months, 12 months, 24 months, and 60 months
UCLA Activity Scale
Baseline, 2-6 weeks, 6 months, 12 months, 24 months, and 60 months
Complications
Time Frame: 2-6 weeks, 6 months, 12 months, 24 months, and 60 months
Complications will be tracked for two years post surgery. Due to previous research, which is outlined below, the following complications will be included in the data collection follow up sheets: angular deformity, revision surgery, time until return to sports, hospital stay, failure/incomplete epiphysiodesis, time until weight bearing, infection, use of aid, number of days using the aid, and osteochondral damage.
2-6 weeks, 6 months, 12 months, 24 months, and 60 months
Medical Costs
Time Frame: 5 years (end of study)
Costs will be collected through hospital administration. In hospital costs and outpatients costs will be included. Indirect costs, such as lost days of parental work will not be considered. Only costs from the United States centers in this protocol will be assessed.
5 years (end of study)
Operative Outcomes
Time Frame: intra-operative
radiation, total time during surgery, skin dose, blood loss, surgeon experience, epiphysiodesis technique, fluoroscopy time
intra-operative
Radiographic Assessments
Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Mechanical Tibial-Femoral Angle, Mechanical Axis Deviation, mLDFA, MPTA, PPTA
Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Emily R Dodwell, MD MPH FRCSC, Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

June 26, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (Estimate)

October 9, 2014

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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