A Randomized Controlled Trial of Leg Length Discrepancy Techniques

NCT02260856 | Terminated DMC

• 1 other identifier: 2014-174
• Study Type: interventional
• Target: 170
• Locations: 2 countries
• Sites: 3

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.

Conditions

Leg Length Discrepancy

Keywords

RCT; Epiphysiodesis; Tantalum beads; Patient centered outcome data; Cost effective analysis

Outcome Measures

Primary Outcomes (1)

• Failure of Epiphysiodesis

  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 Outcomes (14)

• Change in Physeal Growth

  Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months

• Time to Baseline Pain

  Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months

• Quality of Life

  Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months

• Length of Hospital Stay

  An expected average of 2 days

• Time to full weight-bearing

  2- 6 weeks

Study Arms (2)

Percutaneous Drill Epiphysiodesis

ACTIVE COMPARATOR

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.

Device: Tantalum Beads & Injector; Procedure: Percutaneous Drill Epiphysiodesis

Percutaneous Screw Epiphysiodesis

EXPERIMENTAL

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.

Device: Tantalum Beads & Injector; Procedure: Percutaneous Screw Epiphysiodesis

Interventions

Tantalum Beads & Injector DEVICE

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

Also known as: 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

Percutaneous Drill Epiphysiodesis; Percutaneous Screw Epiphysiodesis

Percutaneous Drill Epiphysiodesis PROCEDURE

Percutaneous Drill Epiphysiodesis

Percutaneous Screw Epiphysiodesis PROCEDURE

Percutaneous Screw Epiphysiodesis

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Boston Children's Hospital: collaborator
• The Hospital for Sick Children: collaborator

Study Sites (3)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (14)

• Blair VP 3rd, Walker SJ, Sheridan JJ, Schoenecker PL. Epiphysiodesis: a problem of timing. J Pediatr Orthop. 1982 Aug;2(3):281-4.

  PMID: 7130384 BACKGROUND

• Little DG, Nigo L, Aiona MD. Deficiencies of current methods for the timing of epiphysiodesis. J Pediatr Orthop. 1996 Mar-Apr;16(2):173-9. doi: 10.1097/00004694-199603000-00007.

  PMID: 8742279 BACKGROUND

• 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.

  PMID: 17075098 BACKGROUND

• Haugan K, Husby OS, Klaksvik J, Foss OA. The migration pattern of the Charnley femoral stem: a five-year follow-up RSA study in a well-functioning patient group. J Orthop Traumatol. 2012 Sep;13(3):137-43. doi: 10.1007/s10195-012-0187-x. Epub 2012 May 11.

  PMID: 22576838 BACKGROUND

• 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.

  PMID: 20503949 BACKGROUND

• 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.

  PMID: 21169837 BACKGROUND

• 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.

  PMID: 21292444 BACKGROUND

• 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.

  PMID: 23893420 BACKGROUND

• 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.

  PMID: 24172673 BACKGROUND

• 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.

  PMID: 23740167 BACKGROUND

• Canale ST, Christian CA. Techniques for epiphysiodesis about the knee. Clin Orthop Relat Res. 1990 Jun;(255):81-5.

  PMID: 2347169 BACKGROUND

• 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.

  PMID: 9600565 BACKGROUND

• 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.

  PMID: 23872800 BACKGROUND

• Alzahrani AG, Behairy YM, Alhossan MH, Arab FS, Alammari AA. Percutaneous versus open epiphysiodesis. Saudi Med J. 2003 Feb;24(2):203-5.

  PMID: 12682689 BACKGROUND

MeSH Terms

Conditions

Leg Length Inequality

Interventions

Sterilization, Reproductive

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Contraception; Reproductive Techniques; Therapeutics; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Emily R Dodwell, MD MPH FRCSC

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: October 9, 2014
• Study Start: June 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (2)