[Artificial Disc Replacement] Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up

[Justin]

European Spine Journal.
Volume 18, Number 10 / October, 2009 / Pages 1512-1519

Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up

Svante Berg1 , Tycho Tullberg1, Björn Branth1, Claes Olerud1 and Hans Tropp2
(1) Stockholm Spine Center, Löwenströmska Hospital, 19489 Upplands Väsby, Sweden
(2) University Hospital, 581 85 Linköping, Sweden
© 2009, Springer-Verlag

The study design includes a prospective, randomised controlled study comparing total disc replacement (TDR) with posterior fusion. The main objective of this study is to compare TDR with lumbar spinal fusion, in terms of clinical outcome, in patients referred to a spine clinic for surgical evaluation. Fusion is effective for treating chronic low back pain (LBP), but has drawbacks, such as stiffness and possibly adjacent level degradation. Motion-preserving options have emerged, of which TDR is frequently used because of these drawbacks. How the results of TDR compare to fusion, however, is uncertain. One hundred and fifty-two patients with a mean age of 40 years (21–55) were included: 90 were women, and 80 underwent TDR. The patients had not responded to a conservative treatment programme and suffered from predominantly LBP, with varying degrees of leg pain. Diagnosis was based on clinical examination, radiographs, MRI, and in unclear cases, diagnostic injections. Outcome measures were global assessment (GA), VAS for back and leg pain, Oswestry Disability Index, SF36 and EQ5D at 1 and 2 years. Follow-up rate was 100%, at both 1 and 2 years. All outcome variables improved in both groups between preoperative and follow-up assessment. The primary outcome measure, GA, revealed that 30% in the TDR group and 15% in the fusion group were totally pain-free at 2 years (P = 0.031). TDR patients had reached maximum recovery in virtually all variables at 1 year, with significant differences compared to the fusion group. The fusion patients continued to improve and at 2 years had results similar to TDR patients apart from numbers of pain-free. Complications and reoperations were similar in both groups, but pedicle screw removal as additive surgery, was frequent in the fusion group. One year after surgery, TDR was superior to spinal fusion in clinical outcome, but this difference had diminished by 2 years, apart from (VAS for back pain and) numbers of pain-free. The long-term benefits have yet to be examined.

Degenerative disc disease - Prospective randomised controlled trial - Total disc replacement - Spinal fusion - Patients global assessment of back pain

[KBear]

Very interesting. It's nice to know that the TDR patients were virtually done healing at 1 year, versus the 2 years for fusion. I am surprised that only 30% were pain free. I expected that number to be alot higher.