Leg Length DiscrepancyNCT02260856
A Randomized Controlled Trial of Leg Length Discrepancy Techniques
A study testing Tantalum Beads & Injector, Percutaneous Drill Epiphysiodesis and Percutaneous Screw Epiphysiodesis in people with Leg Length Discrepancy, run by Hospital for Special Surgery, New York at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Leg Length Discrepancy
- What is being tested?
- Tantalum Beads & Injector, Percutaneous Drill Epiphysiodesis and Percutaneous Screw Epiphysiodesis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2015to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: 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.
Read the 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.
- Conditions
- Leg Length Discrepancy
- Being tested
- Tantalum Beads & Injector, Percutaneous Drill Epiphysiodesis, Percutaneous Screw Epiphysiodesis
- Keywords
- RCT, Epiphysiodesis, Tantalum beads, Patient centered outcome data, Cost effective analysis
- Medical subject headings
- Leg Length Inequality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tantalum Beads & InjectorDevice
Also called 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)
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
Percutaneous Drill EpiphysiodesisProcedure or surgery
Percutaneous Screw EpiphysiodesisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Tantalum Beads & Injector; Procedure: Percutaneous Screw Epiphysiodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of Epiphysiodesis
development of angular deformity > 5°, revision epiphysiodesis, or growth inhibition < 70% of expected
Measured: 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Secondary outcomes (14)
Change in Physeal Growth
Distance between tantalum beads.
Measured: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Time to Baseline Pain
Visual Analog Scale
Measured: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Quality of Life
PROMIS Pain Interference and Mobility
Measured: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Length of Hospital Stay
participants will be followed for the duration of hospital stay (discharge date - admission date)
Measured: An expected average of 2 days
Time to full weight-bearing
Documenting the number of days until patient could weight-bear without using devices as crutches or wheelchairs.
Measured: 2- 6 weeks
Need for Splint or Cast
Documenting days worn.
Measured: 2- 6 weeks
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
Measured: 2-6 weeks
Need for Secondary Surgery
Assessed in follow up clinical visits and documented in clinical records
Measured: 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Physical Activity Level
Pediatric activity scale assessment measured by HSS Pedi-FABS.
Measured: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Physical Activity Level
UCLA Activity Scale
Measured: Baseline, 2-6 weeks, 6 months, 12 months, 24 months, and 60 months
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.
Measured: 2-6 weeks, 6 months, 12 months, 24 months, and 60 months
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.
Measured: 5 years (end of study)
Operative Outcomes
radiation, total time during surgery, skin dose, blood loss, surgeon experience, epiphysiodesis technique, fluoroscopy time
Measured: intra-operative
Radiographic Assessments
Mechanical Tibial-Femoral Angle, Mechanical Axis Deviation, mLDFA, MPTA, PPTA
Measured: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startJun 2015
- Primary completionDec 2023
- Study completionDec 2023
Why it stopped: Study expired December 16, 2023 and inactivated due to non response to continuing review 2/1/24. Study never reactivated so it was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Leg Length DiscrepancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, The Hospital for Sick Children
- Responsible party
- Sponsor
- Investigators
- Emily R Dodwell, MD MPH FRCSC, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260856
- Sponsor's protocol ID
- 2014-174
- Status last verified
- Jan 2025
- First submitted
- 26 Jun 2014
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Blair VP 3rd, Walker SJ, Sheridan JJ, Schoenecker PL. Epiphysiodesis: a problem of timing. J Pediatr Orthop. 1982 Aug;2(3):281-4.
PubMed 7130384Little 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.
PubMed 8742279Lauge-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.
PubMed 17075098Haugan 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.
PubMed 22576838Campens 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.
PubMed 20503949Ghanem 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.
PubMed 21169837DeWitt 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.
PubMed 21292444Fabricant 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.
PubMed 23893420Novais 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.
PubMed 24172673Varni 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.
PubMed 23740167Canale ST, Christian CA. Techniques for epiphysiodesis about the knee. Clin Orthop Relat Res. 1990 Jun;(255):81-5.
PubMed 2347169Metaizeau JP, Wong-Chung J, Bertrand H, Pasquier P. Percutaneous epiphysiodesis using transphyseal screws (PETS). J Pediatr Orthop. 1998 May-Jun;18(3):363-9.
PubMed 9600565Stewart 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.
PubMed 23872800Alzahrani AG, Behairy YM, Alhossan MH, Arab FS, Alammari AA. Percutaneous versus open epiphysiodesis. Saudi Med J. 2003 Feb;24(2):203-5.
PubMed 12682689
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEDS Trial: Percutaneous Epiphysiodesis, Drill Versus Screws for Leg Length Discrepancy a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02260856
- Acronym / sponsor ID
- 2014-174
- Conditions
- Leg Length Discrepancy
- Keywords
- RCT, Epiphysiodesis, Tantalum beads, Patient centered outcome data, Cost effective analysis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study expired December 16, 2023 and inactivated due to non response to continuing review 2/1/24. Study never reactivated so it was terminated.
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, The Hospital for Sick Children
- Study start
- Jun 2015
- Primary completion
- Dec 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Drill Epiphysiodesis | Active comparator | Device: Tantalum Beads & Injector, Procedure: Percutaneous Drill EpiphysiodesisA 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. |
| Percutaneous Screw Epiphysiodesis | Experimental | Device: Tantalum Beads & Injector, Procedure: Percutaneous Screw EpiphysiodesisIn 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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tantalum Beads & InjectorAlso: 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)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 | Device | Percutaneous Drill Epiphysiodesis, Percutaneous Screw Epiphysiodesis |
| Percutaneous Drill Epiphysiodesis | Procedure or surgery | Percutaneous Drill Epiphysiodesis |
| Percutaneous Screw Epiphysiodesis | Procedure or surgery | Percutaneous Screw Epiphysiodesis |
Primary outcome
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
14 secondary outcomes
Change in Physeal Growth
Time frame: 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
Quality of Life
Time frame: 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
Time to full weight-bearing
Time frame: 2- 6 weeks
Need for Splint or Cast
Time frame: 2- 6 weeks
Days Until Return to Sports
Time frame: 2-6 weeks
Need for Secondary Surgery
Time frame: 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
Physical Activity Level
Time frame: 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
Medical Costs
Time frame: 5 years (end of study)
Operative Outcomes
Time frame: intra-operative
Radiographic Assessments
Time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
Results and safety
The study was stopped early (reason given: Study expired December 16, 2023 and inactivated due to non response to continuing review 2/1/24. Study never reactivated so it was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Background: PubMed 7130384Blair VP 3rd, Walker SJ, Sheridan JJ, Schoenecker PL. Epiphysiodesis: a problem of timing. J Pediatr Orthop. 1982 Aug;2(3):281-4.
- Background: PubMed 8742279Little 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.
- Background: PubMed 17075098Lauge-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.
- Background: PubMed 22576838Haugan 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.
- Background: PubMed 20503949Campens 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.
- Background: PubMed 21169837Ghanem 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.
- Background: PubMed 21292444DeWitt 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.
- Background: PubMed 23893420Fabricant 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.
- Background: PubMed 24172673Novais 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.
- Background: PubMed 23740167Varni 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.
- Background: PubMed 2347169Canale ST, Christian CA. Techniques for epiphysiodesis about the knee. Clin Orthop Relat Res. 1990 Jun;(255):81-5.
- Background: PubMed 9600565Metaizeau JP, Wong-Chung J, Bertrand H, Pasquier P. Percutaneous epiphysiodesis using transphyseal screws (PETS). J Pediatr Orthop. 1998 May-Jun;18(3):363-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily R Dodwell, MD MPH FRCSC principal investigator
Hospital for Special Surgery, New York
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tantalum Beads & Injector, Percutaneous Drill Epiphysiodesis and Percutaneous Screw Epiphysiodesis in people with Leg Length Discrepancy, run by Hospital for Special Surgery, New York at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study expired December 16, 2023 and inactivated due to non response to continuing review 2/1/24. Study never reactivated so it was terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of Epiphysiodesis (time frame: 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02260856, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.