158.
The Challenges of Recruiting Patients into a Sham Surgery Trial
Kristoffer Hare, Stefan Lohmander, Ewa Roos
Dep. of Orthopedics Institute of Sports Science and Clinical Biomechanics,
University of Southern Denmark/Slagelse Hosp; Dep. of Orthopedics, Clinical
Sciences Lund, University of Lund, Sweden; , Institute of Sports Science and
Clinical Biomechanics, University of Southern Denmark
Background:
The few available orthopaedic placebo controlled surgical trials,
recent editorials and reviews emphasize that comparison against placebo is
needed to examine the true efficacy also of surgical interventions.
Purpose / Aim of Study:
To examine the feasibility of and to identify the
challenges in recruiting patients into a placebo controlled surgical trial of
arthroscopic partial meniscectomy.
Materials and Methods:
Results presented are from an ongoing RCT where
patients aged 35-55 with an MRI confirmed degenerative medial meniscus tear
were randomized to arthroscopic partial meniscectomy or placebo surgery.
Patients referred from general practitioners were screened. If eligible, oral and
written information about the study including a 10 minute video was given to
the patients and they were subsequently invited to participate. If willing they
were referred to an MRI to confirm a meniscus lesion. Only when MRI
confirmed a meniscus lesion were the patients finally included.
Findings / Results:
261
patients have been screened. 109 had clinical signs of
a medial meniscus lesion. 13 declined to receive the patient information, 39
declined after reviewing the patient material and 55 agreed to participate. 2
patients underwent MRI which was negative before being informed of the
study. All 55 patients who were willing to participate underwent MRI. Of
these only 34 had a medial meniscus tear confirmed by MRI (2 pending). In
total 25 patients were finally included from the 261 initially screened.
Conclusions:
Fifty percent of eligible patients agreed to participate in the
study. The number is somewhat higher than earlier surgical placebo controlled
trials from other countries. A high proportion of these patients were later
excluded due to the absence of a medial meniscus lesion on MRI, confirming a
poor correlation between clinical signs and MRI findings.
