The Titanium-coated PEEK Cage Maintains Better Bone Fusion With the Endplate Than the PEEK Cage 6 Months After PLIF Surgery: A Multicenter, Prospective, Randomized Study.
Adult
Aged
Benzophenones
Biocompatible Materials
/ administration & dosage
Female
Humans
Infant
Internal Fixators
/ trends
Ketones
/ administration & dosage
Lumbar Vertebrae
/ diagnostic imaging
Male
Middle Aged
Polyethylene Glycols
/ administration & dosage
Polymers
Prospective Studies
Spinal Fusion
/ instrumentation
Titanium
/ administration & dosage
Journal
Spine
ISSN: 1528-1159
Titre abrégé: Spine (Phila Pa 1976)
Pays: United States
ID NLM: 7610646
Informations de publication
Date de publication:
01 Aug 2020
01 Aug 2020
Historique:
entrez:
18
7
2020
pubmed:
18
7
2020
medline:
4
11
2020
Statut:
ppublish
Résumé
A multicenter, randomized, open-label, parallel-group trial. To investigate interbody bone fusion rates in titanium-coated polyetheretherketone (TiPEEK) and polyetheretherketone (PEEK) cages after posterior lumbar interbody fusion (PLIF) surgery. Previous clinical studies have not revealed any significant difference in bone fusion rates between TiPEEK and PEEK cages. During one-level PLIF surgery, 149 patients (84 men, 65 women, mean age 67 yr) were randomly allocated to use either a TiPEEK cage (n = 69) or PEEK cage (n = 80). Blinded radiographic evaluations were performed using computed tomography and assessed by modified intention-to-treat analysis in 149 cases and per-protocol analysis in 143 cases who were followed for 12 months. Clinical outcomes were assessed using the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and the Oswestry Disability Index. The interbody union rate at 12 months after surgery was 45% owing to a very strict definition of bone fusion. The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted modified intention-to-treat analysis and were significantly higher at 6 months in the unadjusted per-protocol analysis. Binary logistic regression analysis adjusted for sex, age, body mass index, bone mineral density, and surgical level showed that using a TiPEEK cage (odds ratio, 2.27; 95% confidence interval: 1.09-4.74; P = 0.03) was independently associated with bone fusion at 6 months after surgery. Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and Oswestry Disability Index results improved postoperatively in both groups. Using the TiPEEK cage for PLIF enabled the maintenance of better bone fusion to the endplate than using the PEEK cage at 6 months after the surgery. Our findings suggest the possibility of an earlier return to rigorous work or sports by the use of TiPEEK cage. 1.
Sections du résumé
STUDY DESIGN
METHODS
A multicenter, randomized, open-label, parallel-group trial.
OBJECTIVE
OBJECTIVE
To investigate interbody bone fusion rates in titanium-coated polyetheretherketone (TiPEEK) and polyetheretherketone (PEEK) cages after posterior lumbar interbody fusion (PLIF) surgery.
SUMMARY OF BACKGROUND DATA
BACKGROUND
Previous clinical studies have not revealed any significant difference in bone fusion rates between TiPEEK and PEEK cages.
METHODS
METHODS
During one-level PLIF surgery, 149 patients (84 men, 65 women, mean age 67 yr) were randomly allocated to use either a TiPEEK cage (n = 69) or PEEK cage (n = 80). Blinded radiographic evaluations were performed using computed tomography and assessed by modified intention-to-treat analysis in 149 cases and per-protocol analysis in 143 cases who were followed for 12 months. Clinical outcomes were assessed using the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and the Oswestry Disability Index.
RESULTS
RESULTS
The interbody union rate at 12 months after surgery was 45% owing to a very strict definition of bone fusion. The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted modified intention-to-treat analysis and were significantly higher at 6 months in the unadjusted per-protocol analysis. Binary logistic regression analysis adjusted for sex, age, body mass index, bone mineral density, and surgical level showed that using a TiPEEK cage (odds ratio, 2.27; 95% confidence interval: 1.09-4.74; P = 0.03) was independently associated with bone fusion at 6 months after surgery. Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and Oswestry Disability Index results improved postoperatively in both groups.
CONCLUSION
CONCLUSIONS
Using the TiPEEK cage for PLIF enabled the maintenance of better bone fusion to the endplate than using the PEEK cage at 6 months after the surgery. Our findings suggest the possibility of an earlier return to rigorous work or sports by the use of TiPEEK cage.
LEVEL OF EVIDENCE
METHODS
1.
Identifiants
pubmed: 32675599
doi: 10.1097/BRS.0000000000003464
pii: 00007632-202008010-00003
doi:
Substances chimiques
Benzophenones
0
Biocompatible Materials
0
Ketones
0
Polymers
0
polyetheretherketone
31694-16-3
Polyethylene Glycols
3WJQ0SDW1A
Titanium
D1JT611TNE
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
E892-E902Références
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