Distribution of in vivo and in vitro range of motion following 1-level arthroplasty with the CHARITE artificial disc compared with fusion.

Object: One of the goals of lumbar arthroplasty is to restore and maintain range of motion (ROM) and to protect adjacent levels from abnormal motion, which may be a factor in transition syndrome following arthrodesis. In this study, in vitro ROM results were compared with in vivo, 2-year postoperative radiographic ROM evaluations.

Methods: Radiographs of patients enrolled in the CHARITE investigational device exemption study were analyzed at baseline and at 2 years postoperatively.

Prevalence of heterotopic ossification following total disc replacement. A prospective, randomized study of two hundred and seventy-six patients.

Background: Despite reports of good clinical outcomes in patients treated with lumbar and cervical disc replacements, varying degrees of heterotopic bone have been observed around these devices. The purposes of the present study were to determine the prevalence of heterotopic ossification following lumbar disc replacement and to investigate whether heterotopic ossification results in loss of motion or negatively affects clinical outcome.

Methods: All preoperative and postoperative radiographs from a completed prospective, randomized, United States Food and Drug Administration-regulated trial comparing replacement with the CHARITE Artificial Disc with anterior interbody arthrodesis were analyzed.

A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes.

Study Design: A prospective, randomized, multicenter, Food and Drug Administration-regulated, investigational device exemption clinical trial.

Objectives: To compare the safety and effectiveness of lumbar total disc replacement (TDR) with the CHARITE artificial disc (DePuy Spine, Raynham, MA) to anterior lumbar interbody fusion for the treatment of single-level degenerative disc disease from L4-S1 unresponsive to nonoperative treatment. In addition, to evaluate the radiographic outcomes of lumbar artificial disc replacement at either L4-L5 or L5-S1 with the CHARITE artificial disc as compared to anterior lumbar interbody fusion with cylindrical cages and iliac crest bone graft; and to determine if a correlation exists between clinical outcomes and surgical accuracy of TDR placement within the disc space.