Posterior lumbar interbody fusion using non resorbable poly-ether-ether-ketone versus resorbable poly-L-lactide-co-D,L-lactide fusion devices. Clinical outcome at a minimum of 2-year follow-up.
Previous papers on resorbable poly-L-lactide-co-D,L-lactide (PLDLLA) cages in spinal fusion have failed to report adequately on patient-centred clinical outcome measures. Also comparison of PLDLLA cage with a traditionally applicable counterpart has not been previously reported. This is the first randomized prospective study that assesses clinical outcome of PLDLLA cage compared with a poly-ether-ether-ketone (PEEK) implant. Twenty-six patients were randomly assigned to undergo instrumented posterior lumbar interbody fusion (PLIF) whereby either a PEEK cage or a PLDLLA cage was implanted. Clinical outcome based on visual analogue scale scores for leg pain and back pain, as well as Oswestry Disability Index (ODI) and SF-36 questionnaires were documented and analysed. When compared with preoperative values, all clinical parameters have significantly improved in the PEEK group at 2 years after surgery with the exception of SF-36 general health, SF-36 mental health and SF-36 role emotional scores. No clinical parameter showed significant improvement at 2 years after surgery compared with preoperative values in the PLDLLA patient group. Only six patients (50%) in the PLDLLA group showed improvement in the VAS scores for leg and back pain as well as the ODI, as opposed to 10 patients (71%) in the PEEK group. One-third of the patients in the PLDLLA group actually reported worsening of their pain scores and ODI. Three cases of mild to moderate osteolysis were seen in the PLDLLA group. Following up on our preliminary report, these 2-year results confirm the superiority of the PEEK implant to the resorbable PLDLLA implant in aiding spinal fusion and alleviating symptoms following PLIF in patients with degenerative spondylolisthesis associated with either canal stenosis or foramen stenosis or both and emanating from a single lumbar segment.
Jiya
Timothy U
TU
Department of Orthopaedic Surgery, VU University Medical Centre and the Skeletal Tissue Engineering Group, De Boelelaan 1117, Postbus 7057, 1007 MB, Amsterdam, The Netherlands. tu.jiya@vumc.nl
Smit
T
T
van Royen
B J
BJ
Mullender
M
M
D000328:Adult; D000368:Aged; D001577:Benzophenones; D004185:Disability Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007659:Ketones / Q000627:therapeutic use*; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011091:Polyesters / Q000627:therapeutic use*; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011108:Polymers; D011859:Radiography; D013123:Spinal Fusion / Q000379:methods*; D013130:Spinal Stenosis / Q000000981:diagnostic imaging / Q000601:surgery*; D013168:Spondylolisthesis / Q000000981:diagnostic imaging / Q000601:surgery*; D016896:Treatment Outcome
D001577:Benzophenones; D007659:Ketones; D011091:Polyesters; D011108:Polymers; C063834:polyetheretherketone; D011092:Polyethylene Glycols; C033616:poly(lactide)