A two-year study of lumbar disc replacements was published in Spine this month.
The researchers examined results from patients who underwent single level lumbar disc replacement who failed at least six months of nonsurgical management. The patients had degenerative disc disease and were treated with the activL implant or the ProDisc-L or Charite implant.
The activL implant is an investigational device while the ProDisc-L and Charite disc replacement are FDA-approved. There were 218 patients who received the activL and 106 patients who received either ProDisc-L or Charite.
The researchers found:
1. The activL implant was not inferior to the other two FDA-approved implants, according to a primary composite endpoint. A protocol-defined analysis of the primary composite endpoint showed the activL was superior to the other two discs.
2. The activeL had higher radiographic success than the other two implants — 59 percent compared with 43 percent.
3. The average back pain severity improved 74 percent with activL and 68 percent with the control discs. The Oswestry Disability Index scores decreased by 67 percent with activL and decreased 61 percent with ProDisc-L or Charite.
4. The patient satisfaction was more than 90 percent with both groups two years after surgery.
5. The patients returned to work one month earlier with the activL implant compared with the control group.
6. The device-related serious adverse events were lower — 12 percent — with the activL implant when compared with the control group — 19 percent. Surgical intervention at the index level was comparable for both groups — 2.3 percent for activL compared with 1.9 percent for the control group.