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NCT02260856 · ClinicalTrials.gov registry record · NA
A Randomized Controlled Trial of Leg Length Discrepancy Techniques
A NA study, sponsored by Hospital for Special Surgery, New York.
- Terminated
- Registry status
- NA
- Development phase
- 170
- Enrollment target
NCT02260856 is a NA study that was terminated before completion, run by Hospital for Special Surgery, New York. The registered enrollment target is 170 participants.
The verdict
NCT02260856, a NA study, was terminated before completion, sponsored by Hospital for Special Surgery, New York.
- TERMINATED
- Registry status
- NA
- Development phase
- 170 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Tantalum Beads & Injector
- PROCEDURE Percutaneous Drill Epiphysiodesis
- PROCEDURE Percutaneous Screw Epiphysiodesis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2015-06 |
| Est. Completion | 2023-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02260856
The ClinicalTrials.gov registry entry for NCT02260856 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Tantalum Beads & Injector is the first listed.
NCT02260856 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02260856 about?
NCT02260856 is a clinical study titled "A Randomized Controlled Trial of Leg Length Discrepancy Techniques". 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 ...
What is the current status of trial NCT02260856?
This trial is currently terminated. It is a NA study. The enrollment target is 170 participants. The study started on 2015-06. Estimated completion is 2023-12.
What interventions are being tested in trial NCT02260856?
The interventions under investigation include: Tantalum Beads & Injector (DEVICE), Percutaneous Drill Epiphysiodesis (PROCEDURE), Percutaneous Screw Epiphysiodesis (PROCEDURE).
Who is sponsoring clinical trial NCT02260856?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
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