A Randomized Controlled Trial of Leg Length Discrepancy Techniques



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:7 - 18
Updated:10/12/2018
Start Date:June 2015
End Date:June 2020
Contact:Emily R Dodwell, MD MPH FRCSC
Email:dodwelle@hss.edu
Phone:212-606-1451

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
3
sites
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Phone: 617-355-6021
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
?
mi
from
Boston, MA
Click here to add this to my saved trials
535 E 70th St
New York, New York 10021
(212) 606-1000
Principal Investigator: Emily R Dodwell, MD MPH FRCSC
Phone: 212-606-1451
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
?
mi
from
New York, NY
Click here to add this to my saved trials
555 University Avenue
Toronto, Ontario M5G 1X8
Principal Investigator: Martin Gargan, MD FRCSC
Phone: 416-813-7980
?
mi
from
Toronto,
Click here to add this to my saved trials