Developing a placebo-controlled trial in surgery: Issues of design, acceptability and feasibility
2011

Designing a Surgical Placebo-Controlled Trial for Knee Osteoarthritis

Sample size: 49 publication Evidence: moderate

Author Information

Author(s): MK Campbell, VA Entwistle, BH Cuthbertson, ZC Skea, AG Sutherland, AM McDonald, JD Norrie, RV Carlson, S Bridgman

Primary Institution: Health Services Research Unit, University of Aberdeen, Aberdeen, UK

Hypothesis

Can a surgical placebo-controlled trial be designed to evaluate the effectiveness of arthroscopic lavage for knee osteoarthritis?

Conclusion

A placebo-controlled trial for arthroscopic lavage can be conducted, but it faces significant feasibility challenges.

Supporting Evidence

  • Surgeons and anaesthetists showed broad acceptance of the need for further evaluation of arthroscopic lavage.
  • Patients expressed willingness to participate in a trial with a placebo arm despite some apprehension.
  • Ethics committee approval was challenging to obtain, indicating the controversial nature of surgical placebos.

Takeaway

The study looked at whether it's possible to do a surgery trial where some patients get a fake surgery instead of the real one, and found it could work but is really complicated.

Methodology

The study involved focus groups and surveys with surgeons, anaesthetists, and patients to assess the acceptability and feasibility of a surgical placebo.

Potential Biases

Potential biases in participant selection and the subjective nature of pain assessment.

Limitations

The study faced challenges in gaining ethics approval and local authorizations, which limited the pilot's execution.

Participant Demographics

Participants included surgeons, anaesthetists, and patients with knee osteoarthritis.

Digital Object Identifier (DOI)

10.1186/1745-6215-12-50

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