Background/objectives:
Use of a placebo control is probably the single most important design feature trialists can add to a trial to minimise bias. However, these trials are still scarce in the field of musculoskeletal surgery with evidence supporting most surgical procedures coming from open trials. Conducting placebo trials of surgery can, however, be challenging. We are currently leading the first placebo-controlled trial of spinal surgery – the SucceSS trial – a large, government funded study that will evaluate surgical decompression for spinal stenosis. The SUcceSS trial will randomly allocate 160 people with symptomatic spinal canal stenosis to receive either decompressive surgery or placebo surgery. The placebo surgery arm receives identical treatment to the active arm except that no bone removal (decompression) is performed. Patients, investigators other than the treating surgeon, clinicians and assessors are blinded to treatment allocation. Trial recruitment has commenced at multiple sites across Sydney and Melbourne. We aim to discuss the barriers and solutions encountered when designing, implementing and conducting a placebo controlled trial of surgery in Australia.
Methods and Results: the need for placebo-controlled trials of surgery will be presented. The design implications of placebo trials of surgery, including the ASPIRE guidance on methods for placebo comparator group selection in surgical trials will be presented. The different stages of the design and implementation of placebo trials of surgery, securing surgeon buy-in, funding, ethics approval, governance approval and trial feasibility at public and private hospitals, hospital billing and surgical costs, blinding of hospital staff, minimizing crossover rates, patient recruitment and follow up will also be discussed.
Conclusion: By sharing the experience in designing and conducting the first placebo-controlled trial of spinal surgery, Prof Ferreira will aim to establish the need and feasibility of placebo-controlled trials of musculoskeletal surgery among researchers and clinicians.