Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial

B. Gareb; N. B. van Bakelen; G. J. Buijs; J. Jansma; J. G. A. M. de Visscher; Th. J. M. Hoppenreijs; J. E. Bergsma; B. van Minnen; B. Stegenga; R. R. M. Bos

doi:10.1371/journal.pone.0177152

Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial

B. Gareb^*, N. B. van Bakelen, G. J. Buijs, J. Jansma, J. G. A. M. de Visscher, Th. J. M. Hoppenreijs, J. E. Bergsma, B. van Minnen, B. Stegenga, R. R. M. Bos

^*Corresponding author for this work

Personalized Healthcare Technology (PHT)

Research output: Contribution to journal › Article › Academic › peer-review

11 Citations (Scopus)

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Abstract

Background

Biodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation.

Aim

The aim of this study was to compare the long-term (i.e. >5 years postoperatively) clinical performance of a titanium and a biodegradable system in oral and maxillofacial surgery.

Materials and methods

The present multicenter Randomized Controlled Trial (RCT) was performed in four hospitals in the Netherlands. Patients treated with a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy, and those treated for fractures of the mandible, maxilla, or zygoma were included from December 2006 to July 2009. The patients were randomly assigned to either a titanium (KLS Martin) or a biodegradable group (Inion CPS).

Results

After >5 years postoperatively, plate removal was performed in 22 of the 134 (16.4%) patients treated with titanium and in 23 of the 87 (26.4%) patients treated with the biodegradable system (P = 0.036, hazard ratio (HR) biodegradable (95% CI) = 2.0 (1.05-3.8), HR titanium = 1). Occlusion, VAS pain scores, and MFIQ showed good and (almost) pain free mandibular function in both groups.

Conclusion

In conclusion, the performance of the Inion CPS biodegradable system was inferior compared to the KLS Martin titanium system regarding plate/screws removal in the abovementioned surgical procedures.

Original language	English
Number of pages	12
Journal	PLoS ONE
Volume	12
Issue number	5
DOIs	https://doi.org/10.1371/journal.pone.0177152
Publication status	Published - 11-May-2017

Keywords

POLY(L-LACTIDE) BONE PLATES
ORTHOGNATHIC SURGERY
MANDIBULAR FRACTURES
IN-VITRO
REMOVAL
DEVICES
SCREWS
OSTEOSYNTHESIS
COMPLICATIONS
VIVO

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Cite this

Gareb, B., van Bakelen, N. B., Buijs, G. J., Jansma, J., de Visscher, J. G. A. M., Hoppenreijs, T. J. M., Bergsma, J. E., van Minnen, B., Stegenga, B., & Bos, R. R. M. (2017). Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial. PLoS ONE, 12(5). https://doi.org/10.1371/journal.pone.0177152

Gareb, B. ; van Bakelen, N. B. ; Buijs, G. J. ; Jansma, J. ; de Visscher, J. G. A. M. ; Hoppenreijs, Th. J. M. ; Bergsma, J. E. ; van Minnen, B. ; Stegenga, B. ; Bos, R. R. M. / Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery : A multicenter randomized controlled trial. In: PLoS ONE. 2017 ; Vol. 12, No. 5.

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title = "Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial",

abstract = "BackgroundBiodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation.AimThe aim of this study was to compare the long-term (i.e. >5 years postoperatively) clinical performance of a titanium and a biodegradable system in oral and maxillofacial surgery.Materials and methodsThe present multicenter Randomized Controlled Trial (RCT) was performed in four hospitals in the Netherlands. Patients treated with a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy, and those treated for fractures of the mandible, maxilla, or zygoma were included from December 2006 to July 2009. The patients were randomly assigned to either a titanium (KLS Martin) or a biodegradable group (Inion CPS).ResultsAfter >5 years postoperatively, plate removal was performed in 22 of the 134 (16.4%) patients treated with titanium and in 23 of the 87 (26.4%) patients treated with the biodegradable system (P = 0.036, hazard ratio (HR) biodegradable (95% CI) = 2.0 (1.05-3.8), HR titanium = 1). Occlusion, VAS pain scores, and MFIQ showed good and (almost) pain free mandibular function in both groups.ConclusionIn conclusion, the performance of the Inion CPS biodegradable system was inferior compared to the KLS Martin titanium system regarding plate/screws removal in the abovementioned surgical procedures.",

keywords = "POLY(L-LACTIDE) BONE PLATES, ORTHOGNATHIC SURGERY, MANDIBULAR FRACTURES, IN-VITRO, REMOVAL, DEVICES, SCREWS, OSTEOSYNTHESIS, COMPLICATIONS, VIVO",

author = "B. Gareb and {van Bakelen}, {N. B.} and Buijs, {G. J.} and J. Jansma and {de Visscher}, {J. G. A. M.} and Hoppenreijs, {Th. J. M.} and Bergsma, {J. E.} and {van Minnen}, B. and B. Stegenga and Bos, {R. R. M.}",

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Gareb, B, van Bakelen, NB, Buijs, GJ, Jansma, J, de Visscher, JGAM, Hoppenreijs, TJM, Bergsma, JE, van Minnen, B, Stegenga, B & Bos, RRM 2017, 'Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial', PLoS ONE, vol. 12, no. 5. https://doi.org/10.1371/journal.pone.0177152

Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery : A multicenter randomized controlled trial. / Gareb, B.; van Bakelen, N. B.; Buijs, G. J.; Jansma, J.; de Visscher, J. G. A. M.; Hoppenreijs, Th. J. M.; Bergsma, J. E.; van Minnen, B.; Stegenga, B.; Bos, R. R. M.

In: PLoS ONE, Vol. 12, No. 5, 11.05.2017.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery

T2 - A multicenter randomized controlled trial

AU - Gareb, B.

AU - van Bakelen, N. B.

AU - Buijs, G. J.

AU - Jansma, J.

AU - de Visscher, J. G. A. M.

AU - Hoppenreijs, Th. J. M.

AU - Bergsma, J. E.

AU - van Minnen, B.

AU - Stegenga, B.

AU - Bos, R. R. M.

PY - 2017/5/11

Y1 - 2017/5/11

N2 - BackgroundBiodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation.AimThe aim of this study was to compare the long-term (i.e. >5 years postoperatively) clinical performance of a titanium and a biodegradable system in oral and maxillofacial surgery.Materials and methodsThe present multicenter Randomized Controlled Trial (RCT) was performed in four hospitals in the Netherlands. Patients treated with a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy, and those treated for fractures of the mandible, maxilla, or zygoma were included from December 2006 to July 2009. The patients were randomly assigned to either a titanium (KLS Martin) or a biodegradable group (Inion CPS).ResultsAfter >5 years postoperatively, plate removal was performed in 22 of the 134 (16.4%) patients treated with titanium and in 23 of the 87 (26.4%) patients treated with the biodegradable system (P = 0.036, hazard ratio (HR) biodegradable (95% CI) = 2.0 (1.05-3.8), HR titanium = 1). Occlusion, VAS pain scores, and MFIQ showed good and (almost) pain free mandibular function in both groups.ConclusionIn conclusion, the performance of the Inion CPS biodegradable system was inferior compared to the KLS Martin titanium system regarding plate/screws removal in the abovementioned surgical procedures.

AB - BackgroundBiodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation.AimThe aim of this study was to compare the long-term (i.e. >5 years postoperatively) clinical performance of a titanium and a biodegradable system in oral and maxillofacial surgery.Materials and methodsThe present multicenter Randomized Controlled Trial (RCT) was performed in four hospitals in the Netherlands. Patients treated with a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy, and those treated for fractures of the mandible, maxilla, or zygoma were included from December 2006 to July 2009. The patients were randomly assigned to either a titanium (KLS Martin) or a biodegradable group (Inion CPS).ResultsAfter >5 years postoperatively, plate removal was performed in 22 of the 134 (16.4%) patients treated with titanium and in 23 of the 87 (26.4%) patients treated with the biodegradable system (P = 0.036, hazard ratio (HR) biodegradable (95% CI) = 2.0 (1.05-3.8), HR titanium = 1). Occlusion, VAS pain scores, and MFIQ showed good and (almost) pain free mandibular function in both groups.ConclusionIn conclusion, the performance of the Inion CPS biodegradable system was inferior compared to the KLS Martin titanium system regarding plate/screws removal in the abovementioned surgical procedures.

KW - POLY(L-LACTIDE) BONE PLATES

KW - ORTHOGNATHIC SURGERY

KW - MANDIBULAR FRACTURES

KW - IN-VITRO

KW - REMOVAL

KW - DEVICES

KW - SCREWS

KW - OSTEOSYNTHESIS

KW - COMPLICATIONS

KW - VIVO

U2 - 10.1371/journal.pone.0177152

DO - 10.1371/journal.pone.0177152

M3 - Article

C2 - 28493922

VL - 12

JO - PLOS-One

JF - PLOS-One

SN - 1932-6203

IS - 5

ER -