BACKGROUND: Low back pain is one of the most prevalent problems in industrialized countries, affecting as many as 80% of all adults at some time in their lives. Among the significant contributors to low back pain is degenerative disc disease (DDD). Although fusion has been well accepted for treatment of DDD, high rates of complications and stress to adjacent segments remain a concern. Lumbar total disc replacement (TDR) was developed with a goal of preserving motion and avoiding various fusion-related complications, but the relative merits of single vs. multiple level arthroplasty remain unclear. METHODS: This is a multi-center, single arm, prospective post-market registry of the M6-L, consisting of consecutive patients presenting with lumbar DDD who agreed to participate. This paper reports on those patients who have completed at least 24 months of followup to date. Clinical outcome measures include the Oswestry Disability Index (ODI) and back and leg Visual Analogue Scales (VAS). Radiographic analysis of disc angle and range of motion (ROM) was also performed. RESULTS: Results for 83 patients comprising 121 implants in two cohorts (49 single level (SL), 34 multiple levels (ML)) are reported. Both cohorts experienced significant improvement at 24 months including significant decreases in ODI and VAS. Relative to SL procedures, ML procedures demonstrated either comparable results, or results that trended favorably towards the ML procedures. Index and global ROM at 24 months were not significantly different between the two cohorts, while the disc angles were larger in the SL cohort regardless of index level. CONCLUSIONS: This is the first study to report clinical and radiographic outcomes of TDR with the M6-L in SL vs ML procedures with two years of followup. The results suggest initial device safety and effectiveness when used for the treatment of lumbar degenerative disc disease at one or more levels.
BACKGROUND:Low back pain is one of the most prevalent problems in industrialized countries, affecting as many as 80% of all adults at some time in their lives. Among the significant contributors to low back pain is degenerative disc disease (DDD). Although fusion has been well accepted for treatment of DDD, high rates of complications and stress to adjacent segments remain a concern. Lumbar total disc replacement (TDR) was developed with a goal of preserving motion and avoiding various fusion-related complications, but the relative merits of single vs. multiple level arthroplasty remain unclear. METHODS: This is a multi-center, single arm, prospective post-market registry of the M6-L, consisting of consecutive patients presenting with lumbar DDD who agreed to participate. This paper reports on those patients who have completed at least 24 months of followup to date. Clinical outcome measures include the Oswestry Disability Index (ODI) and back and leg Visual Analogue Scales (VAS). Radiographic analysis of disc angle and range of motion (ROM) was also performed. RESULTS: Results for 83 patients comprising 121 implants in two cohorts (49 single level (SL), 34 multiple levels (ML)) are reported. Both cohorts experienced significant improvement at 24 months including significant decreases in ODI and VAS. Relative to SL procedures, ML procedures demonstrated either comparable results, or results that trended favorably towards the ML procedures. Index and global ROM at 24 months were not significantly different between the two cohorts, while the disc angles were larger in the SL cohort regardless of index level. CONCLUSIONS: This is the first study to report clinical and radiographic outcomes of TDR with the M6-L in SL vs ML procedures with two years of followup. The results suggest initial device safety and effectiveness when used for the treatment of lumbar degenerative disc disease at one or more levels.
Entities:
Keywords:
Low Back Pain; lumbar disc disease; total disc replacement
Authors: Rudolf Bertagnoli; James J Yue; Rahul V Shah; Regina Nanieva; Frank Pfeiffer; Andrea Fenk-Mayer; Trace Kershaw; Daniel S Husted Journal: Spine (Phila Pa 1976) Date: 2005-10-01 Impact factor: 3.468
Authors: Rudolf Bertagnoli; James J Yue; Rahul V Shah; Regina Nanieva; Frank Pfeiffer; Andrea Fenk-Mayer; Trace Kershaw; Daniel S Husted Journal: Spine (Phila Pa 1976) Date: 2005-10-01 Impact factor: 3.468
Authors: Scott Blumenthal; Paul C McAfee; Richard D Guyer; Stephen H Hochschuler; Fred H Geisler; Richard T Holt; Rolando Garcia; John J Regan; Donna D Ohnmeiss Journal: Spine (Phila Pa 1976) Date: 2005-07-15 Impact factor: 3.468
Authors: Christoph J Siepe; Wolfgang Hitzl; Peter Meschede; Ajay K Sharma; Mohamed F Khattab; Michael H Mayer Journal: Spine (Phila Pa 1976) Date: 2009-04-20 Impact factor: 3.468
Authors: Matthew Hannibal; Derek J Thomas; Jeffrey Low; Ken Y Hsu; James Zucherman Journal: Spine (Phila Pa 1976) Date: 2007-10-01 Impact factor: 3.468
Authors: Matthew Scott-Young; So Mang Simon Lee; David Nielsen; Evelyne Rathbone; Matthew Rackham; Wayne Hing Journal: Spine (Phila Pa 1976) Date: 2022-03-01 Impact factor: 3.468
Authors: Amparo Vanaclocha-Saiz; Carlos M Atienza; Vicente Vanaclocha; Vicente Belloch; Juan Manuel Santabarbara; Pablo Jordá-Gómez; Leyre Vanaclocha Journal: N Am Spine Soc J Date: 2020-07-20