Expert Consensus and Equipoise: Planning a Randomized Controlled Trial of Magnetically Controlled Growing Rods

Area of Science:

• Pediatric Orthopedics
• Spine Surgery
• Medical Device Technology

Background:

• Magnetically controlled growing rods (MCGRs) represent a novel technology for treating early-onset scoliosis (EOS).
• Significant uncertainty exists regarding optimal MCGR use, including construct design, lengthening timing, and distraction amount.
• Expert consensus is crucial for guiding the development of clinical research, such as randomized controlled trials (RCTs).

Purpose of the Study:

• To assess the current expert equipoise regarding MCGR utilization in EOS treatment.
• To establish consensus among pediatric spine surgeons for designing a future RCT evaluating MCGRs.
• To identify key areas of uncertainty that warrant further investigation.

Main Methods:

• A combined Delphi method and Nominal group technique approach was employed.
• Two rounds of surveys with case examples were administered to experienced pediatric spine surgeons.
• Face-to-face meetings were conducted to refine consensus and plan a potential RCT for MCGRs.

Main Results:

• Experts reached a consensus on standardizing MCGRs to bidirectional constructs for an RCT.
• The planned RCT will randomize patients to either 6-week or 16-week lengthening intervals.
• A standardized equation was agreed upon for calculating total yearly lengthening to mimic natural spine growth.

Conclusions:

• Expert opinion supports the use of MCGRs for children over 6 years with scoliosis curves exceeding 60 degrees.
• The identified uncertainties regarding lengthening frequency provide a strong rationale for conducting an RCT.
• This consensus-building process facilitates the advancement of MCGR technology and its application in pediatric spine care.