Bunionectomy is a highly standardized, rapidly recruiting boney pain model.

 

As a CRO and research site, Lotus Clinical Research is nationally recognized for its experience and proficiency in bunionectomy research.

For bunionectomy trials, Lotus Clinical Research provides both site and CRO services. We can perform single-center bunionectomy studies within our own walls. When a multicenter environment is required, Lotus Clinical Research utilizes a network of five well-vetted, geographically diverse bunionectomy sites.

The key to success in bunionectomy research is minimization of variability and placebo response. To accomplish this, our CRO and site utilize the Lotus Clinical Research subject placebo response education toolkit. This toolkit has been successfully deployed when we serve as the single bunionectomy center and/or in multicenter bunionectomy trials when Lotus Clinical Research serves as the CRO.

Efforts are made to reduce variability among subjects in multicenter experiments by homogenizing the:

  • Surgical techniques: first metatarsal Austin bunionectomy without collateral procedures
  • Anesthetic technique: propofol sedation with may block; procedure performed with or without popiteal block depending on protocol requirements
  • Recovery room procedures: standardized analgesic regimens, avoidance of ice, ambulation disallowed
  • Inpatient stay: private rooms, comingling discouraged, restricted ambulation, no visitation from family or friends.

Enrollment

Average enrollment is 30 randomized subjects per month at the Lotus Clinical Research site. Screen failure rates are typically low, but are dependent on the specifics of the clinical protocol and its inclusion/exclusion criteria.

PhaseSponsorEnrolled by LotusTotal Study NClinical Trials.gov Identifier
2Heron53100NCT02471898
2AcelRx50110NCT01710345
2Recro50150NCT02284243
3Covidien89320NCT01484652
3Covidien89320NCT01743625
4Regenesis70300NCT01694199
3J&J155897NCT00613938
3Teva53560NCT02487108