NCT01055574

Physical Capability Outcomes After Single-Level PD-L vs Single-Level ALIF: a Multi-Center Clinical Trial

Physical Capability Outcomes After Single-Level ProDisc-L Total Disc Replacement or Single-Level Anterior Lumbar Interbody Fusion: a Multi-Center Clinical Trial

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: Gundersen Lutheran Medical Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the physical capability outcomes of patients who undergo single-level ProDisc-L disc replacement with those of patients who undergo stand-alone, single-level anterior lumbar interbody fusion (ALIF). This study will be the first multi-center clinical study to use clearly measurable outcomes from physical tests to compare the results of lumbar disc arthroplasty with disc fusion.

Detailed description

Physical capability testing will be conducted once before surgery and at 6 months and 1 year after surgery. Physical capability testing assesses the ability to perform a number of common tasks: the distance a subject can walk comfortably in 6 minutes; the amount of weight a subject can lift, push, pull, and carry; and the ability to squat and work bending forward in the kneeling and standing positions. The results of this testing will be evaluated to determine whether the subject's physical capability meets the physical requirements of their job, based on their responses to a pre-study questionnaire. Each physical capability testing session will require from 1 to 1 ½ hours of the subject's time. Physical capability testing will be provided without charge.

Conditions

• Physical Capability Outcomes

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2010-01-25
• Last updated: 2011-09-09

Locations

6 sites across 1 country: United States