[Surgical randomized controlled trial of two procedures for hallux valgus: recruitment failure]

Randomized controlled surgical trials (RCST) are the optimal way to validate new surgical treatments, yet RCSTs comprise a very small fraction of published articles in the surgical literature. One of most frequent reasons for lack of success in RCSTs is the failure to recruit an adequate number of patients.

We report the results of 14 months of recruitment for an RCST comparing two different surgical procedures for the treatment of painful hallux valgus. The study is an open-label non-inferiority parallel trial, with an accrual goal of 100 subjects in 24 months.

In the first 14 months of recruitment, 94 patients were assessed for eligibility, of which 54 were excluded and 40 were protocol-eligible. Of these 40 only 13 enrolled in the trial. Eleven patients were randomized and treated according to the protocol, the other two withdrew prior to randomization. Of the 27 eligible patients who did not enroll and the 2 eligible patients who withdrew prior to ramdomization, 22 declined to participate in the study and 7 elected to have surgical treatment but refused randomization.

The data show that investigators planning RCST's in surgery should be aware of the large amount of effort and significant financial resources needed to achieve patient recruitment goals.