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A Randomized Controlled Trial of Leg Length Discrepancy Techniques

Primary Purpose

Leg Length Discrepancy

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Tantalum Beads & Injector
Percutaneous Drill Epiphysiodesis
Percutaneous Screw Epiphysiodesis
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Length Discrepancy focused on measuring RCT, Epiphysiodesis, Tantalum beads, Patient centered outcome data, Cost effective analysis

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's Hospital
  • Hospital for Special SurgeryRecruiting
  • Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Percutaneous Drill Epiphysiodesis

Percutaneous Screw Epiphysiodesis

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Failure of Epiphysiodesis
development of angular deformity > 5°, revision epiphysiodesis, or growth inhibition < 70% of expected

Secondary Outcome Measures

Change in Physeal Growth
Distance between tantalum beads.
Time to Baseline Pain
Visual Analog Scale
Quality of Life
PROMIS Pain Interference and Mobility
Length of Hospital Stay
participants will be followed for the duration of hospital stay (discharge date - admission date)
Time to full weight-bearing
Documenting the number of days until patient could weight-bear without using devices as crutches or wheelchairs.
Need for Splint or Cast
Documenting days worn.
Days Until Return to Sports
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
Need for Secondary Surgery
Assessed in follow up clinical visits and documented in clinical records
Physical Activity Level
Pediatric activity scale assessment measured by HSS Pedi-FABS.
Physical Activity Level
UCLA Activity Scale
Complications
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.
Medical Costs
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.
Operative Outcomes
radiation, total time during surgery, skin dose, blood loss, surgeon experience, epiphysiodesis technique, fluoroscopy time
Radiographic Assessments
Mechanical Tibial-Femoral Angle, Mechanical Axis Deviation, mLDFA, MPTA, PPTA

Full Information

First Posted
June 26, 2014
Last Updated
March 15, 2023
Sponsor
Hospital for Special Surgery, New York
Collaborators
Boston Children's Hospital, The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT02260856
Brief Title
A Randomized Controlled Trial of Leg Length Discrepancy Techniques
Official Title
PEDS Trial: Percutaneous Epiphysiodesis, Drill Versus Screws for Leg Length Discrepancy A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
Collaborators
Boston Children's Hospital, The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Length Discrepancy
Keywords
RCT, Epiphysiodesis, Tantalum beads, Patient centered outcome data, Cost effective analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous Drill Epiphysiodesis
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Percutaneous Screw Epiphysiodesis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Tantalum Beads & Injector
Other Intervention Name(s)
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
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Drill Epiphysiodesis
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Screw Epiphysiodesis
Primary Outcome Measure Information:
Title
Failure of Epiphysiodesis
Description
development of angular deformity > 5°, revision epiphysiodesis, or growth inhibition < 70% of expected
Time Frame
2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Secondary Outcome Measure Information:
Title
Change in Physeal Growth
Description
Distance between tantalum beads.
Time Frame
Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Title
Time to Baseline Pain
Description
Visual Analog Scale
Time Frame
Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Title
Quality of Life
Description
PROMIS Pain Interference and Mobility
Time Frame
Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Title
Length of Hospital Stay
Description
participants will be followed for the duration of hospital stay (discharge date - admission date)
Time Frame
An expected average of 2 days
Title
Time to full weight-bearing
Description
Documenting the number of days until patient could weight-bear without using devices as crutches or wheelchairs.
Time Frame
2- 6 weeks
Title
Need for Splint or Cast
Description
Documenting days worn.
Time Frame
2- 6 weeks
Title
Days Until Return to Sports
Description
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
Time Frame
2-6 weeks
Title
Need for Secondary Surgery
Description
Assessed in follow up clinical visits and documented in clinical records
Time Frame
2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Title
Physical Activity Level
Description
Pediatric activity scale assessment measured by HSS Pedi-FABS.
Time Frame
Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Title
Physical Activity Level
Description
UCLA Activity Scale
Time Frame
Baseline, 2-6 weeks, 6 months, 12 months, 24 months, and 60 months
Title
Complications
Description
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.
Time Frame
2-6 weeks, 6 months, 12 months, 24 months, and 60 months
Title
Medical Costs
Description
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.
Time Frame
5 years (end of study)
Title
Operative Outcomes
Description
radiation, total time during surgery, skin dose, blood loss, surgeon experience, epiphysiodesis technique, fluoroscopy time
Time Frame
intra-operative
Title
Radiographic Assessments
Description
Mechanical Tibial-Femoral Angle, Mechanical Axis Deviation, mLDFA, MPTA, PPTA
Time Frame
Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily R Dodwell, MD MPH FRCSC
Phone
212-606-1451
Email
dodwelle@hss.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kunal N Agarwal, MS
Phone
212-774-2121
Email
agarwalk@hss.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily R Dodwell, MD MPH FRCSC
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Snyder, MD PhD
Phone
617-355-6021
Email
Brian.Snyder@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Benton Heyworth, MD
Phone
617-355-6021
Email
Benton.Heyworth@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Benton Heyworth, MD
First Name & Middle Initial & Last Name & Degree
Brian Snyder, MD PhD
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Dodwell, MD MPH FRCSC
Phone
212-606-1451
Email
dodwelle@hss.edu
First Name & Middle Initial & Last Name & Degree
Roger Widmann, MD
Phone
212- 606-1325
Email
widmannr@hss.edu
First Name & Middle Initial & Last Name & Degree
Emily R Dodwell, MD MPH FRCSC
First Name & Middle Initial & Last Name & Degree
Roger F Widmann, MD
First Name & Middle Initial & Last Name & Degree
Daniel W Green, MD
First Name & Middle Initial & Last Name & Degree
John S Blanco, MD
First Name & Middle Initial & Last Name & Degree
Shevaun M Doyle, MD
First Name & Middle Initial & Last Name & Degree
David M Scher, MD
First Name & Middle Initial & Last Name & Degree
Jo Hannafin, MD PhD
First Name & Middle Initial & Last Name & Degree
Robert Marx, MD
First Name & Middle Initial & Last Name & Degree
Stephen Lyman, PhD
First Name & Middle Initial & Last Name & Degree
Douglas Mintz, MD
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Gargan, MD FRCSC
Phone
416-813-7980
Email
martin.gargan@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Martin Gargan, MD FRCSC
First Name & Middle Initial & Last Name & Degree
James G Wright, MD MPH FRCSC
First Name & Middle Initial & Last Name & Degree
Simon Kelley, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
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Citation
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Citation
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17075098
Citation
Lauge-Pedersen H, Hagglund G, Johnsson R. Radiostereometric analysis for monitoring percutaneous physiodesis. A preliminary study. J Bone Joint Surg Br. 2006 Nov;88(11):1502-7. doi: 10.1302/0301-620X.88B11.17730.
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Citation
Campens C, Mousny M, Docquier PL. Comparison of three surgical epiphysiodesis techniques for the treatment of lower limb length discrepancy. Acta Orthop Belg. 2010 Apr;76(2):226-32.
Results Reference
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PubMed Identifier
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Citation
Ghanem I, Karam JA, Widmann RF. Surgical epiphysiodesis indications and techniques: update. Curr Opin Pediatr. 2011 Feb;23(1):53-9. doi: 10.1097/MOP.0b013e32834231b3.
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DeWitt EM, Stucky BD, Thissen D, Irwin DE, Langer M, Varni JW, Lai JS, Yeatts KB, Dewalt DA. Construction of the eight-item patient-reported outcomes measurement information system pediatric physical function scales: built using item response theory. J Clin Epidemiol. 2011 Jul;64(7):794-804. doi: 10.1016/j.jclinepi.2010.10.012. Epub 2011 Feb 2.
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PubMed Identifier
23893420
Citation
Fabricant PD, Robles A, Downey-Zayas T, Do HT, Marx RG, Widmann RF, Green DW. Development and validation of a pediatric sports activity rating scale: the Hospital for Special Surgery Pediatric Functional Activity Brief Scale (HSS Pedi-FABS). Am J Sports Med. 2013 Oct;41(10):2421-9. doi: 10.1177/0363546513496548. Epub 2013 Jul 26.
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Novais EN, Heyworth BE, Stamoulis C, Sullivan K, Millis MB, Kim YJ. Open surgical treatment of femoroacetabular impingement in adolescent athletes: preliminary report on improvement of physical activity level. J Pediatr Orthop. 2014 Apr-May;34(3):287-94. doi: 10.1097/BPO.0000000000000093.
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Varni JW, Thissen D, Stucky BD, Liu Y, Magnus B, Quinn H, Irwin DE, DeWitt EM, Lai JS, Amtmann D, Gross HE, DeWalt DA. PROMIS(R) Parent Proxy Report Scales for children ages 5-7 years: an item response theory analysis of differential item functioning across age groups. Qual Life Res. 2014 Feb;23(1):349-61. doi: 10.1007/s11136-013-0439-0. Epub 2013 Jun 6.
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Metaizeau JP, Wong-Chung J, Bertrand H, Pasquier P. Percutaneous epiphysiodesis using transphyseal screws (PETS). J Pediatr Orthop. 1998 May-Jun;18(3):363-9.
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Stewart D, Cheema A, Szalay EA. Dual 8-plate technique is not as effective as ablation for epiphysiodesis about the knee. J Pediatr Orthop. 2013 Dec;33(8):843-6. doi: 10.1097/BPO.0b013e3182a11d23.
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A Randomized Controlled Trial of Leg Length Discrepancy Techniques

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