Clinical experience with porous tantalum cervical interbody implants in a prospective randomized controlled trial.

A prospective randomized study was undertaken to evaluate the radiological appearance and clinical effectiveness of two porous tantalum (Hedrocel) implants in achieving a stable cervical interbody fusion. A prerandomization protocol was used to allocate patients to the three arms of the study: a ring implant containing autologous cancellous bone graft, a solid block implant or autologous tricortical iliac crest bone graft. Patients were followed for 2 years with plain radiological studies, SF-36, and Neck Disability Index questionnaires and neurological assessment. Early in the study the postoperative radiographs of four patients receiving Hedrocel implants showed inferior end-plate lucency raising concerns about delayed or non-fusion. Recruitment to the study was halted by the investigators to allow longer-term follow-up of the implanted patients when only 24 patients had been recruited to the study. Although fusion was subsequently noted in all patients at 12 months there was no further enrolment to the study. At 2 years the radiological and clinical outcomes of the three groups appeared comparable, but the study numbers were too small for any statistical analysis. This study highlights the difficulties that can arise when clinical caution takes precedence over objective measures of clinical progress during a study. In the absence of an independent safety monitoring committee, the investigators were under an ethical obligation to suspend recruitment to this study, until it was clear that the radiological features were not associated with poor clinical outcomes. The use of safety monitoring committees and the clarification of stopping criteria in relation to outcome measures should be considered in open randomized trials of spinal surgical techniques and implants.

RCT Entities:   Population Interventions Outcomes