Spondylolisthesis Clinical Trial
Official title:
SurgerySMART: Studying Melatonin and Recovery in Teens
The goal of this feasibility clinical trial is to learn if melatonin can help teens having major musculoskeletal surgery by promoting healthy sleep. Melatonin is available as a dietary supplement that may be effective in promoting longer, higher quality sleep. This study will assess the feasibility and acceptability of melatonin for teens undergoing major musculoskeletal surgery, as well as determine optimal measured outcomes (sleep, pain, health-related quality of life) at short- and long-term follow-up.
The investigators will enroll a total of 45 adolescents ages 12-18 years old who are scheduled to undergo major musculoskeletal surgery and one of their caregivers who meet inclusion and exclusion criteria. Participants will be asked to: 1. Take melatonin or a placebo before and after surgery. All participants will receive sleep hygiene instructions. 2. Wear a watch-like actigraphy device before and after surgery 3. Complete 1-minute check-in surveys twice each day, for about 5 weeks total before and after surgery 4. Complete 10-20-minute online surveys 3 times over 4 months. Researchers will compare participants randomized to the placebo arm and melatonin arm to see if the trial design and outcomes are both feasible and acceptable to patients and their families. The main aims are: Aim 1. To assess the feasibility and acceptability of melatonin for youth undergoing musculoskeletal surgery Aim 2. To determine optimal primary and secondary outcomes (sleep, pain, health-related quality of life) at short-term (during the initial 21 days) and at final follow-up (3 months after surgery). The investigators will examine completion rates, the extent and pattern of missing data, and gather data to provide effect estimates, variances, and 95% confidence intervals. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03883022 -
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
|
N/A | |
| Active, not recruiting |
NCT04542577 -
PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D
|
||
| Recruiting |
NCT04477447 -
PMCF Study on the Safety and Performance of CESPACE 3D
|
||
| Completed |
NCT02558621 -
New Robotic Assistance System for Spinal Fusion Surgery
|
N/A | |
| Terminated |
NCT01461005 -
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
|
N/A | |
| Completed |
NCT00405691 -
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
|
Phase 3 | |
| Completed |
NCT00205101 -
Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
|
||
| Enrolling by invitation |
NCT04204135 -
The Course of Hip Flexion Weakness Following LLIF or ALIF
|
||
| Recruiting |
NCT05238740 -
Comparison of Standalone Anterior Lumbar Interbody Fusion (ALIF) L5/S1 Performed With Either rhBMP-2 or ViviGen®
|
N/A | |
| Completed |
NCT02931279 -
PASS OCT® Post-market Clinical Follow-up
|
||
| Not yet recruiting |
NCT02805985 -
Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device
|
N/A | |
| Completed |
NCT02966639 -
Validation of Appropriateness Criteria for the Surgical Treatment of Lumbar Degenerative Spondylolisthesis
|
||
| Active, not recruiting |
NCT02057744 -
MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries
|
||
| Completed |
NCT01711203 -
The Addition of a Pilates Program for Short-Term Improvements in Patients With Spondylolysis or Spondylolisthesis
|
N/A | |
| Completed |
NCT00549913 -
Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)
|
Phase 1/Phase 2 | |
| Terminated |
NCT00254852 -
Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft
|
N/A | |
| Terminated |
NCT00095095 -
Lumbar Interbody Fusion Using the Telamon® Peek™ Versus the Telamon® Hydrosorb™ Fusion Device
|
Phase 4 | |
| Active, not recruiting |
NCT03956537 -
PMCF Neo Pedicle Screw and Cage Systems
|
||
| Recruiting |
NCT05182489 -
Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages
|
N/A | |
| Completed |
NCT02884440 -
Transverse Abdominis Plane Block for Anterior Approach Spine Surgery
|
Phase 2 |